<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255382</url>
  </required_header>
  <id_info>
    <org_study_id>M16-178</org_study_id>
    <secondary_id>2016-003718-28</secondary_id>
    <nct_id>NCT03255382</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy</brief_title>
  <official_title>A Randomized, Controlled, Multicenter, Open Label Study With Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)&#xD;
      risankizumab and oral FUMADERM provided as study medication in participants with moderate to&#xD;
      severe plaque psoriasis who are naïve to and candidates for systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy analysis was performed in the Intent to Treat (ITT) set which included all&#xD;
      participants who were randomized. The safety analysis was performed in the safety set which&#xD;
      included all participants who received at least one dose of study drug. No participants were&#xD;
      excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued&#xD;
      after randomization prior to receiving any study drug and were thus not included in the&#xD;
      safety set.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI: Change From Baseline to Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI: Change From Baseline to Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI: Change From Baseline to Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 20</measure>
    <time_frame>Week 20</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA Score of Clear at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PSS Score of 0 at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSS Total Score: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSS Total Score: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Patient Benefit Index (PBI) at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of PBI at Week 24</measure>
    <time_frame>Baseline Week 24</time_frame>
    <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NAPPA-CLIN Total Score: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PPASI: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA Affected by Psoriasis: Change From Baseline to Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA Affected by Psoriasis: Change From Baseline to Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA Affected by Psoriasis: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA Affected by Psoriasis: Change From Baseline to Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA Affected by Psoriasis: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 V2 PCS Score: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 V2 MCS Score: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Global Assessment (PtGA): Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PtGA: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety &amp; Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADS Total Score-Anxiety: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADS Total Score-Depression: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADS Total Score-Depression: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DLQI Total Score: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DLQI: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSSI: Change From Baseline at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L Total Score: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L VAS: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NAPSI: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Risankizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fumaderm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fumaderm</intervention_name>
    <description>Fumaderm tablet administered orally</description>
    <arm_group_label>Fumaderm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>risankizumab</intervention_name>
    <description>Risankizumab administered by subcutaneous (SC) injection</description>
    <arm_group_label>Risankizumab</arm_group_label>
    <other_name>ABBV-066</other_name>
    <other_name>BI 655066</other_name>
    <other_name>SKYRIZI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first&#xD;
             administration of study drug. Duration since diagnosis may be reported by the&#xD;
             participant&#xD;
&#xD;
          -  Participant has stable moderate to severe plaque psoriasis (body surface area [BSA]&#xD;
             &gt;10, Psoriasis Area and Severity Index [PASI] &gt;10, and Dermatology Quality of Life&#xD;
             Index [DLQI] &gt;10) with or without psoriatic arthritis at Baseline&#xD;
&#xD;
          -  Must be naïve to and candidate for systemic therapy, as assessed by the investigator&#xD;
&#xD;
          -  Participant has an inadequate response, intolerance or contraindication to topical&#xD;
             psoriasis treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with non-plaque forms of psoriasis&#xD;
&#xD;
          -  Participant has previously received systemic therapy for psoriasis, whether biologic&#xD;
             or non-biologic or photochemotherapy&#xD;
&#xD;
          -  Active systemic infection during the last 2 weeks (exception: common cold) prior to&#xD;
             screening.&#xD;
&#xD;
          -  Any documented active or suspected malignancy or history of malignancy within 5 years&#xD;
             prior to screening, except appropriately treated basal or squamous cell carcinoma of&#xD;
             the skin or in situ carcinoma of uterine cervix&#xD;
&#xD;
          -  Participant has any condition or contraindication to Fumaderm that would preclude the&#xD;
             patient's participation in the present study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitaetsklinik Heidelberg /ID# 161014</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Erlangen /ID# 161035</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt /ID# 161036</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Munster /ID# 165739</name>
      <address>
        <city>Munster</city>
        <state>Niedersachsen</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Wesling Klin Minden /ID# 161015</name>
      <address>
        <city>Minden</city>
        <state>Nordrhein-Westfalen</state>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMS3 Company for Medical Study /ID# 161103</name>
      <address>
        <city>Selters (Westerwald)</city>
        <state>Rheinland-Pfalz</state>
        <zip>56242</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Hosp Schleswig-Holstein /ID# 160995</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 161102</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24148</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Campus Mitte /ID# 165621</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISA GmbH /ID# 165619</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis /ID# 161037</name>
      <address>
        <city>Blankenfeld-mahlow</city>
        <zip>15831</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautzentrum Niesmann Othlingha /ID# 161034</name>
      <address>
        <city>Bochum</city>
        <zip>44803</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn /ID# 165618</name>
      <address>
        <city>Bonn</city>
        <zip>53113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautklinik Klinikum Darmstadt /ID# 164940</name>
      <address>
        <city>Darmstadt</city>
        <zip>64297</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetklinikum Dresden /ID# 160983</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Klinik Eppendorf Hamburg /ID# 161038</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tfs /Id# 160994</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik fur Dermatologie /ID# 161101</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Johannes Gutenberg /ID# 161104</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TU Uniklinik Munchen /ID# 160996</name>
      <address>
        <city>Munich</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Tubingen /ID# 165620</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoffmann, Witten, DE /ID# 165622</name>
      <address>
        <city>Witten</city>
        <zip>58453</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centroderm Wuppertal /ID# 165615</name>
      <address>
        <city>Wuppertal</city>
        <zip>42287</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>May 3, 2019</results_first_submitted>
  <results_first_submitted_qc>August 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2019</results_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ABBV-0066</keyword>
  <keyword>BI 655066</keyword>
  <keyword>risankizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Fumarate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03255382/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03255382/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).</recruitment_details>
      <pre_assignment_details>A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fumaderm</title>
          <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
        </group>
        <group group_id="P2">
          <title>Risankizumab</title>
          <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) analysis set: all participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Fumaderm</title>
          <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
        </group>
        <group group_id="B2">
          <title>Risankizumab</title>
          <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.5" spread="12.71"/>
                    <measurement group_id="B2" value="42.0" spread="13.75"/>
                    <measurement group_id="B3" value="42.3" spread="13.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24</title>
        <description>The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>Intent to Treat (ITT) analysis set: all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24</title>
          <description>The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.</description>
          <population>Intent to Treat (ITT) analysis set: all participants who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>73.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>61.3</ci_lower_limit>
            <ci_upper_limit>85.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>46.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.8</ci_lower_limit>
            <ci_upper_limit>60.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3"/>
                    <measurement group_id="O2" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>63.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>50.2</ci_lower_limit>
            <ci_upper_limit>76.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>53.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>40.4</ci_lower_limit>
            <ci_upper_limit>65.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>39.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.3</ci_lower_limit>
            <ci_upper_limit>51.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.3"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>36.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.1</ci_lower_limit>
            <ci_upper_limit>48.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>46.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.7</ci_lower_limit>
            <ci_upper_limit>59.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>9.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>19.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>66.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.8</ci_lower_limit>
            <ci_upper_limit>79.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>66.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.3</ci_lower_limit>
            <ci_upper_limit>79.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                    <measurement group_id="O2" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>66.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.8</ci_lower_limit>
            <ci_upper_limit>79.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>56.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.0</ci_lower_limit>
            <ci_upper_limit>70.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>64.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>52.5</ci_lower_limit>
            <ci_upper_limit>77.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.392</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>36.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.8</ci_lower_limit>
            <ci_upper_limit>49.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="61.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>56.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>43.2</ci_lower_limit>
            <ci_upper_limit>70.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7"/>
                    <measurement group_id="O2" value="76.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>64.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>51.5</ci_lower_limit>
            <ci_upper_limit>78.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>66.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.3</ci_lower_limit>
            <ci_upper_limit>79.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.991</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.323</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>3.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>21.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.4</ci_lower_limit>
            <ci_upper_limit>32.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>33.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.7</ci_lower_limit>
            <ci_upper_limit>45.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>41.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.3</ci_lower_limit>
            <ci_upper_limit>55.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>44.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.9</ci_lower_limit>
            <ci_upper_limit>58.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.37" spread="0.669"/>
                    <measurement group_id="O2" value="-9.56" spread="0.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-7.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.825</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.82</ci_lower_limit>
            <ci_upper_limit>-5.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PASI: Change From Baseline to Week 8</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PASI: Change From Baseline to Week 8</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.61" spread="0.759"/>
                    <measurement group_id="O2" value="-15.18" spread="0.763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-9.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.936</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.43</ci_lower_limit>
            <ci_upper_limit>-7.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PASI: Change From Baseline to Week 12</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PASI: Change From Baseline to Week 12</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.69" spread="0.788"/>
                    <measurement group_id="O2" value="-16.49" spread="0.793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-8.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.972</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.72</ci_lower_limit>
            <ci_upper_limit>-6.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PASI: Change From Baseline to Week 16</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PASI: Change From Baseline to Week 16</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.11" spread="0.777"/>
                    <measurement group_id="O2" value="-16.89" spread="0.782"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-7.78</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.958</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.68</ci_lower_limit>
            <ci_upper_limit>-5.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PASI: Change From Baseline to Week 20</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PASI: Change From Baseline to Week 20</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.46" spread="0.894"/>
                    <measurement group_id="O2" value="-17.35" spread="0.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-7.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.101</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.07</ci_lower_limit>
            <ci_upper_limit>-5.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PASI: Change From Baseline to Week 24</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PASI: Change From Baseline to Week 24</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.31" spread="0.953"/>
                    <measurement group_id="O2" value="-17.69" spread="0.959"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-8.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.175</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.71</ci_lower_limit>
            <ci_upper_limit>-6.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>29.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.1</ci_lower_limit>
            <ci_upper_limit>42.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0"/>
                    <measurement group_id="O2" value="81.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>66.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.4</ci_lower_limit>
            <ci_upper_limit>80.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>56.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42.7</ci_lower_limit>
            <ci_upper_limit>70.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7"/>
                    <measurement group_id="O2" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>59.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.3</ci_lower_limit>
            <ci_upper_limit>73.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.3"/>
                    <measurement group_id="O2" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>44.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.8</ci_lower_limit>
            <ci_upper_limit>59.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>55.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>41.2</ci_lower_limit>
            <ci_upper_limit>68.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 4</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 4</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.392</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 8</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 8</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>8.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>16.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 12</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 12</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>18.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.1</ci_lower_limit>
            <ci_upper_limit>29.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 16</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 16</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>33.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.2</ci_lower_limit>
            <ci_upper_limit>45.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 20</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 20</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 20</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>41.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.3</ci_lower_limit>
            <ci_upper_limit>55.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear at Week 24</title>
        <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear at Week 24</title>
          <description>The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean &gt;0, &lt;1.5; Mild (2) = mean ≥1.5, &lt;2.5; Moderate (3) = mean ≥2.5, &lt;3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>46.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.6</ci_lower_limit>
            <ci_upper_limit>60.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16</title>
        <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16</title>
          <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>19.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.6</ci_lower_limit>
            <ci_upper_limit>31.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PSS Score of 0 at Week 24</title>
        <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PSS Score of 0 at Week 24</title>
          <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>38.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.0</ci_lower_limit>
            <ci_upper_limit>51.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSS Total Score: Change From Baseline to Week 16</title>
        <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PSS Total Score: Change From Baseline to Week 16</title>
          <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="0.52"/>
                    <measurement group_id="O2" value="-8.7" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated by stratified van Elteren test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>van Elteren test</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>-2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSS Total Score: Change From Baseline to Week 24</title>
        <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PSS Total Score: Change From Baseline to Week 24</title>
          <description>The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.6" spread="0.49"/>
                    <measurement group_id="O2" value="-9.5" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated by stratified van Elteren test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>van Elteren test</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>-2.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Patient Benefit Index (PBI) at Week 16</title>
        <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Patient Benefit Index (PBI) at Week 16</title>
          <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.970" spread="1.1971"/>
                    <measurement group_id="O2" value="3.118" spread="0.8246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>1.146</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.764</ci_lower_limit>
            <ci_upper_limit>1.528</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of PBI at Week 24</title>
        <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of PBI at Week 24</title>
          <description>The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;did not apply to me&quot; (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.997" spread="1.2710"/>
                    <measurement group_id="O2" value="3.316" spread="0.7487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>1.320</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.936</ci_lower_limit>
            <ci_upper_limit>1.704</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16</title>
        <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16</title>
          <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.51"/>
                    <measurement group_id="O2" value="-2.7" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-2.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NAPPA-CLIN Total Score: Change From Baseline to Week 24</title>
        <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>NAPPA-CLIN Total Score: Change From Baseline to Week 24</title>
          <description>The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.53"/>
                    <measurement group_id="O2" value="-3.7" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16</title>
        <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16</title>
          <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.76" spread="0.251"/>
                    <measurement group_id="O2" value="-1.04" spread="0.249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.352</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.307</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PPASI: Change From Baseline to Week 24</title>
        <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PPASI: Change From Baseline to Week 24</title>
          <description>The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.87" spread="0.242"/>
                    <measurement group_id="O2" value="-1.17" spread="0.240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.315</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.296</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.86"/>
                    <measurement group_id="O2" value="-5.2" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-4.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>-2.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BSA Affected by Psoriasis: Change From Baseline to Week 8</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>BSA Affected by Psoriasis: Change From Baseline to Week 8</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="1.33"/>
                    <measurement group_id="O2" value="-12.8" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-9.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.6</ci_lower_limit>
            <ci_upper_limit>-6.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BSA Affected by Psoriasis: Change From Baseline to Week 12</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>BSA Affected by Psoriasis: Change From Baseline to Week 12</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0" spread="1.22"/>
                    <measurement group_id="O2" value="-16.2" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-10.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.2</ci_lower_limit>
            <ci_upper_limit>-7.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BSA Affected by Psoriasis: Change From Baseline to Week 16</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>BSA Affected by Psoriasis: Change From Baseline to Week 16</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="1.22"/>
                    <measurement group_id="O2" value="-18.0" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-9.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>-6.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BSA Affected by Psoriasis: Change From Baseline to Week 20</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>BSA Affected by Psoriasis: Change From Baseline to Week 20</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="1.13"/>
                    <measurement group_id="O2" value="-19.3" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-9.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.4</ci_lower_limit>
            <ci_upper_limit>-6.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BSA Affected by Psoriasis: Change From Baseline to Week 24</title>
        <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>BSA Affected by Psoriasis: Change From Baseline to Week 24</title>
          <description>BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>percentage estimated body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" spread="1.19"/>
                    <measurement group_id="O2" value="-19.8" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-10.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.9</ci_lower_limit>
            <ci_upper_limit>-7.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16</title>
        <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16</title>
          <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.87" spread="1.153"/>
                    <measurement group_id="O2" value="7.36" spread="1.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>4.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.385</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.74</ci_lower_limit>
            <ci_upper_limit>7.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SF-36 V2 PCS Score: Change From Baseline to Week 24</title>
        <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>SF-36 V2 PCS Score: Change From Baseline to Week 24</title>
          <description>The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.68" spread="1.104"/>
                    <measurement group_id="O2" value="8.31" spread="1.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>4.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.322</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.01</ci_lower_limit>
            <ci_upper_limit>7.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16</title>
        <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16</title>
          <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="1.493"/>
                    <measurement group_id="O2" value="10.86" spread="1.472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>6.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.787</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.11</ci_lower_limit>
            <ci_upper_limit>10.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SF-36 V2 MCS Score: Change From Baseline to Week 24</title>
        <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>SF-36 V2 MCS Score: Change From Baseline to Week 24</title>
          <description>The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="1.494"/>
                    <measurement group_id="O2" value="11.41" spread="1.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>7.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.784</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.31</ci_lower_limit>
            <ci_upper_limit>11.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Global Assessment (PtGA): Change From Baseline to Week 16</title>
        <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Global Assessment (PtGA): Change From Baseline to Week 16</title>
          <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.11"/>
                    <measurement group_id="O2" value="-1.9" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PtGA: Change From Baseline to Week 24</title>
        <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PtGA: Change From Baseline to Week 24</title>
          <description>The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (&quot;complete disease control&quot;) to 3 (&quot;uncontrolled disease&quot;). LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.11"/>
                    <measurement group_id="O2" value="-2.0" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety &amp; Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16</title>
        <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety &amp; Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16</title>
          <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="0.48"/>
                    <measurement group_id="O2" value="-4.3" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-2.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>-0.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HADS Total Score-Anxiety: Change From Baseline to Week 24</title>
        <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>HADS Total Score-Anxiety: Change From Baseline to Week 24</title>
          <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.49"/>
                    <measurement group_id="O2" value="-4.0" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-2.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HADS Total Score-Depression: Change From Baseline to Week 16</title>
        <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>HADS Total Score-Depression: Change From Baseline to Week 16</title>
          <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.50"/>
                    <measurement group_id="O2" value="-4.9" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.61</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HADS Total Score-Depression: Change From Baseline to Week 24</title>
        <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>HADS Total Score-Depression: Change From Baseline to Week 24</title>
          <description>The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="0.54"/>
                    <measurement group_id="O2" value="-4.8" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.65</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16</title>
        <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16</title>
          <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>38.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.6</ci_lower_limit>
            <ci_upper_limit>53.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24</title>
        <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24</title>
          <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.</description>
          <population>ITT analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>56.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42.7</ci_lower_limit>
            <ci_upper_limit>70.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DLQI Total Score: Change From Baseline to Week 16</title>
        <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>DLQI Total Score: Change From Baseline to Week 16</title>
          <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="0.94"/>
                    <measurement group_id="O2" value="-17.0" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-7.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.6</ci_lower_limit>
            <ci_upper_limit>-5.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DLQI: Change From Baseline to Week 24</title>
        <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>DLQI: Change From Baseline to Week 24</title>
          <description>The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" spread="0.87"/>
                    <measurement group_id="O2" value="-18.8" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-7.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.7</ci_lower_limit>
            <ci_upper_limit>-5.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16</title>
        <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16</title>
          <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.6" spread="1.01"/>
                    <measurement group_id="O2" value="-21.2" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-6.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.0</ci_lower_limit>
            <ci_upper_limit>-4.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSSI: Change From Baseline at Week 24</title>
        <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>PSSI: Change From Baseline at Week 24</title>
          <description>The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.9" spread="1.25"/>
                    <measurement group_id="O2" value="-22.0" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-8.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.1</ci_lower_limit>
            <ci_upper_limit>-5.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16</title>
        <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16</title>
          <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.083" spread="0.0179"/>
                    <measurement group_id="O2" value="0.171" spread="0.0176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.087</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0215</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.045</ci_lower_limit>
            <ci_upper_limit>0.130</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L Total Score: Change From Baseline to Week 24</title>
        <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L Total Score: Change From Baseline to Week 24</title>
          <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.106" spread="0.0155"/>
                    <measurement group_id="O2" value="0.165" spread="0.0152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.059</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0186</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.022</ci_lower_limit>
            <ci_upper_limit>0.096</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16</title>
        <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16</title>
          <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="2.32"/>
                    <measurement group_id="O2" value="26.0" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>14.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.4</ci_lower_limit>
            <ci_upper_limit>20.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L VAS: Change From Baseline to Week 24</title>
        <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L VAS: Change From Baseline to Week 24</title>
          <description>The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="2.29"/>
                    <measurement group_id="O2" value="28.4" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>16.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.73</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.4</ci_lower_limit>
            <ci_upper_limit>22.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16</title>
        <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16</title>
          <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="2.13"/>
                    <measurement group_id="O2" value="-13.6" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-11.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.64</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.6</ci_lower_limit>
            <ci_upper_limit>-6.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NAPSI: Change From Baseline to Week 24</title>
        <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>NAPSI: Change From Baseline to Week 24</title>
          <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="2.18"/>
                    <measurement group_id="O2" value="-18.1" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-13.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.1</ci_lower_limit>
            <ci_upper_limit>-8.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16</title>
        <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16</title>
          <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="3.11"/>
                    <measurement group_id="O2" value="-21.4" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-17.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.8</ci_lower_limit>
            <ci_upper_limit>-9.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24</title>
        <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fumaderm</title>
            <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab</title>
            <description>Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24</title>
          <description>The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.</description>
          <population>ITT analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0" spread="3.03"/>
                    <measurement group_id="O2" value="-27.5" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-21.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.8</ci_lower_limit>
            <ci_upper_limit>-14.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of risankizumab (up to 31 weeks) or until 1 week after the last dose of Fumaderm(R) (up to 25 weeks).</time_frame>
      <desc>Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).</desc>
      <group_list>
        <group group_id="E1">
          <title>Fumaderm</title>
          <description>Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.</description>
        </group>
        <group group_id="E2">
          <title>Risankizumab</title>
          <description>Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="34" subjects_affected="26" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="57" subjects_affected="32" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="32" subjects_affected="26" subjects_at_risk="57"/>
                <counts group_id="E2" events="47" subjects_affected="35" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="15" subjects_affected="7" subjects_at_risk="57"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="28" subjects_affected="23" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255382
org study id: M16-178
secondary id: 2016-003718-28
nct id: NCT03255382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)
      risankizumab and oral FUMADERM provided as study medication in participants with moderate to
      severe plaque psoriasis who are naïve to and candidates for systemic therapy.
The efficacy analysis was performed in the Intent to Treat (ITT) set which included all
      participants who were randomized. The safety analysis was performed in the safety set which
      included all participants who received at least one dose of study drug. No participants were
      excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued
      after randomization prior to receiving any study drug and were thus not included in the
      safety set.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
time frame: Week 24
description: The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4
time frame: Week 4
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8
time frame: Week 8
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12
time frame: Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16
time frame: Week 16
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20
time frame: Week 20
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24
time frame: Week 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4
time frame: Week 4
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8
time frame: Week 8
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12
time frame: Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
time frame: Week 16
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20
time frame: Week 20
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24
time frame: Week 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4
time frame: Week 4
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8
time frame: Week 8
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12
time frame: Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16
time frame: Week 16
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20
time frame: Week 20
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4
time frame: Week 4
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8
time frame: Week 8
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12
time frame: Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16
time frame: Week 16
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20
time frame: Week 20
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24
time frame: Week 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
measure: Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4
time frame: Baseline, Week 4
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.
measure: PASI: Change From Baseline to Week 8
time frame: Baseline, Week 8
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
measure: PASI: Change From Baseline to Week 12
time frame: Baseline, Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
measure: PASI: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
measure: PASI: Change From Baseline to Week 20
time frame: Baseline, Week 20
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
measure: PASI: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4
time frame: Week 4
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8
time frame: Week 8
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12
time frame: Week 12
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16
time frame: Week 16
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20
time frame: Week 20
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24
time frame: Week 24
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 4
time frame: Week 4
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 8
time frame: Week 8
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 12
time frame: Week 12
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 16
time frame: Week 16
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 20
time frame: Week 20
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear at Week 24
time frame: Week 24
description: The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
measure: Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16
time frame: Week 16
description: The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
measure: Percentage of Participants With PSS Score of 0 at Week 24
time frame: Week 24
description: The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
measure: PSS Total Score: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
measure: PSS Total Score: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
measure: Summary of Patient Benefit Index (PBI) at Week 16
time frame: Baseline, Week 16
description: The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
measure: Summary of PBI at Week 24
time frame: Baseline Week 24
description: The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
measure: Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
measure: NAPPA-CLIN Total Score: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
measure: Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
measure: PPASI: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
measure: Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4
time frame: Baseline, Week 4
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: BSA Affected by Psoriasis: Change From Baseline to Week 8
time frame: Baseline, Week 8
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: BSA Affected by Psoriasis: Change From Baseline to Week 12
time frame: Baseline, Week 12
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: BSA Affected by Psoriasis: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: BSA Affected by Psoriasis: Change From Baseline to Week 20
time frame: Baseline, Week 20
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: BSA Affected by Psoriasis: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
measure: Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: SF-36 V2 PCS Score: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16
time frame: Baseline, Week 16
description: The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: SF-36 V2 MCS Score: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: Patient's Global Assessment (PtGA): Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 ("complete disease control") to 3 ("uncontrolled disease"). LOCF imputation was used for missing data.
measure: PtGA: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 ("complete disease control") to 3 ("uncontrolled disease"). LOCF imputation was used for missing data.
measure: Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
measure: HADS Total Score-Anxiety: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
measure: HADS Total Score-Depression: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
measure: HADS Total Score-Depression: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
measure: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
time frame: Week 16
description: The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
measure: Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24
time frame: Week 24
description: The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
measure: DLQI Total Score: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
measure: DLQI: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
measure: Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16
time frame: Baseline, Week 16
description: The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: PSSI: Change From Baseline at Week 24
time frame: Baseline, Week 24
description: The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
measure: EQ-5D-5L Total Score: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
measure: EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
measure: EQ-5D-5L VAS: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
measure: Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: NAPSI: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16
time frame: Baseline, Week 16
description: The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
measure: Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24
time frame: Baseline, Week 24
description: The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
arm group label: Risankizumab
arm group type: Experimental
description: Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
arm group label: Fumaderm
arm group type: Active Comparator
description: Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.
intervention type: Drug
intervention name: Fumaderm
description: Fumaderm tablet administered orally
arm group label: Fumaderm
intervention type: Drug
intervention name: risankizumab
description: Risankizumab administered by subcutaneous (SC) injection
arm group label: Risankizumab
other name: ABBV-066
other name: BI 655066
other name: SKYRIZI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: Germany
url: http://rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Dimethyl Fumarate
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
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