<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/NCT03000075</url>
  </required_header>
  <id_info>
    <org_study_id>M16-004</org_study_id>
    <secondary_id>1311.38</secondary_id>
    <nct_id>NCT03000075</nct_id>
  </id_info>
  <brief_title>BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis</brief_title>
  <official_title>A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized double blind, double dummy, placebo controlled, parallel design study&#xD;
      that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were randomized to receive either placebo, risankizumab 75 mg, or risankizumab&#xD;
      150 mg in Part A. All participants received 2 injections to maintain the blind: the placebo&#xD;
      arm received 2 injections of placebo, the risankizumab 75 mg arm received one injection of&#xD;
      risankizumab 75 mg and one injection of placebo, and the risankizumab 150 mg arm received 2&#xD;
      injections of risankizumab 75 mg. Participants who received placebo in Part A switched to&#xD;
      risankizumab in Part B; participants who received risankizumab (75 mg or 150 mg) in Part A&#xD;
      continued to receive the same treatment (risankizumab 75 mg or 150 mg) in Part B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2016</start_date>
  <completion_date type="Actual">June 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 21, 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI90 at Week 52 (Part B)</measure>
    <time_frame>Week 52</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. Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)</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. Nonresponder imputation (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 52 (Part B)</measure>
    <time_frame>Week 52</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. Nonresponder imputation (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 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI75 at Week 52 (Part B)</measure>
    <time_frame>Week 52</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. Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI100 at Week 52 (Part B)</measure>
    <time_frame>Week 52</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)</measure>
    <time_frame>Week 16</time_frame>
    <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)</measure>
    <time_frame>Week 52</time_frame>
    <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risankizumab 75 mg (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risankizumab 150 mg (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>risankizumab</intervention_name>
    <description>Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection</description>
    <arm_group_label>Risankizumab 150 mg (Part A)</arm_group_label>
    <arm_group_label>Risankizumab 75 mg (Part A)</arm_group_label>
    <other_name>ABBV-066</other_name>
    <other_name>BI 655066</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo for risankizumab</intervention_name>
    <description>Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_label>Risankizumab 75 mg (Part A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for&#xD;
             at least 6 months before the first administration of study drug. Duration of diagnosis&#xD;
             may be reported by the patient.&#xD;
&#xD;
          -  Have stable moderate to severe chronic plaque psoriasis with or without psoriatic&#xD;
             arthritis at both Screening and Baseline (Randomisation):&#xD;
&#xD;
               1. Have an involved body surface area (BSA) ≥10% and&#xD;
&#xD;
               2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and&#xD;
&#xD;
               3. Have a Static Physician Global Assessment (sPGA) score of ≥3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with&#xD;
&#xD;
               1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)&#xD;
&#xD;
               2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta&#xD;
                  blockers, calcium channel blockers, or lithium)&#xD;
&#xD;
               3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis&#xD;
                  that might confound trial evaluations according to investigator's judgment&#xD;
&#xD;
          -  Previous exposure to BI 655066&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <removed_countries>
    <country>Japan</country>
  </removed_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>September 6, 2018</results_first_submitted>
  <results_first_submitted_qc>September 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 6, 2019</results_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BI 655066</keyword>
  <keyword>ABBV-066</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>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <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>June 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03000075/Prot_002.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 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03000075/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 182 subjects were enrolled; 11 subjects failed screening and are excluded from the analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="P2">
          <title>Risankizumab 75 mg (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="P3">
          <title>Risankizumab 150 mg (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="P4">
          <title>Placebo/Risankizumab 75 mg (Part B)</title>
          <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="P5">
          <title>Placebo/Risankizumab 150 mg (Part B)</title>
          <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="P6">
          <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
          <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="P7">
          <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
          <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" 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="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="27">Participants who received placebo in Part A received risankizumab 75 mg in Part B</participants>
                <participants group_id="P5" count="27">Participants who received placebo in Part A received risankizumab 150 mg in Part B</participants>
                <participants group_id="P6" count="58">Participants who received risankizumab 75 mg in Part A received risankizumab 75 mg in Part B</participants>
                <participants group_id="P7" count="55">Participants who received risankizumab 150 mg in Part A received risankizumab 150 mg in Part B</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="26"/>
                <participants group_id="P6" count="56"/>
                <participants group_id="P7" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not dosed due to AE</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population: all participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="B2">
          <title>Risankizumab 75 mg (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="B3">
          <title>Risankizumab 150 mg (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="B4">
          <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="58"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="55"/>
            <count group_id="B4" value="171"/>
          </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="50.9" spread="11.24"/>
                    <measurement group_id="B2" value="51.5" spread="12.33"/>
                    <measurement group_id="B3" value="53.3" spread="11.94"/>
                    <measurement group_id="B4" value="51.9" spread="11.82"/>
                  </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="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="143"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="171"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="171"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" 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 group_id="B4" 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 (PASI) Score (PASI90) at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Intent-to-treat (ITT) population: all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 75 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 150 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>Intent-to-treat (ITT) population: 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="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="55"/>
              </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="75.9"/>
                    <measurement group_id="O3" value="74.5"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>73.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.2</ci_lower_limit>
            <ci_upper_limit>85.0</ci_upper_limit>
            <estimate_desc>95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>72.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.6</ci_lower_limit>
            <ci_upper_limit>84.1</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PASI90 at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O4">
            <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PASI90 at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.5"/>
                    <measurement group_id="O2" value="85.2"/>
                    <measurement group_id="O3" value="86.2"/>
                    <measurement group_id="O4" value="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 75 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 150 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3"/>
                    <measurement group_id="O2" value="86.2"/>
                    <measurement group_id="O3" value="92.7"/>
                  </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>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>75.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>63.8</ci_lower_limit>
            <ci_upper_limit>86.2</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>82.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72.2</ci_lower_limit>
            <ci_upper_limit>92.6</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O4">
            <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.3"/>
                    <measurement group_id="O2" value="88.9"/>
                    <measurement group_id="O3" value="84.5"/>
                    <measurement group_id="O4" value="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 75 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 150 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="89.7"/>
                    <measurement group_id="O3" value="94.5"/>
                  </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>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>80.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.1</ci_lower_limit>
            <ci_upper_limit>90.4</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>86.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.8</ci_lower_limit>
            <ci_upper_limit>95.1</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PASI75 at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O4">
            <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PASI75 at Week 52 (Part B)</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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="88.9"/>
                    <measurement group_id="O3" value="94.8"/>
                    <measurement group_id="O4" value="96.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 75 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 150 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="22.4"/>
                    <measurement group_id="O3" value="32.7"/>
                  </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>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>22.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.8</ci_lower_limit>
            <ci_upper_limit>33.4</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>32.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.0</ci_lower_limit>
            <ci_upper_limit>45.0</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PASI100 at Week 52 (Part B)</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O4">
            <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PASI100 at Week 52 (Part B)</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 a 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. Nonresponder imputation (NRI) was used for missing data.</description>
          <population>ITT population</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="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="44.4"/>
                    <measurement group_id="O3" value="43.1"/>
                    <measurement group_id="O4" value="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)</title>
        <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Among participants with confirmed diagnosis of PsA using classification criteria for psoriatic arthritis (CASPAR) and with baseline total tender joint count (TJC) and swollen joint count (SJC) counts ≥ 3 at selected study sites of the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 75 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 150 mg (Part A)</title>
            <description>Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)</title>
          <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
          <population>Among participants with confirmed diagnosis of PsA using classification criteria for psoriatic arthritis (CASPAR) and with baseline total tender joint count (TJC) and swollen joint count (SJC) counts ≥ 3 at selected study sites of the ITT population.</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="3"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" 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>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.131</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>39.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.6</ci_lower_limit>
            <ci_upper_limit>90.1</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs &gt; 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.</non_inferiority_desc>
            <p_value>0.269</p_value>
            <p_value_desc>P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted percentage difference</param_type>
            <param_value>31.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.2</ci_lower_limit>
            <ci_upper_limit>86.7</ci_upper_limit>
            <estimate_desc>95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)</title>
        <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>Among participants with confirmed diagnosis of PsA using CASPAR criteria and with baseline TJC and SJC counts ≥ 3 at selected study sites of the ITT population,</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
          <group group_id="O4">
            <title>Risankizumab150 mg /Risankizumab 150 mg (Part B)</title>
            <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)</title>
          <description>Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.</description>
          <population>Among participants with confirmed diagnosis of PsA using CASPAR criteria and with baseline TJC and SJC counts ≥ 3 at selected study sites of the ITT population,</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="1"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="60.0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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 16 weeks after the last dose of study drug (up to 56 weeks).</time_frame>
      <desc>TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="E2">
          <title>Risankizumab 75 mg (Part A)</title>
          <description>Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="E3">
          <title>Risankizumab 150 mg (Part A)</title>
          <description>): Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).</description>
        </group>
        <group group_id="E4">
          <title>Placebo/Risankizumab 75 mg (Part B)</title>
          <description>Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="E5">
          <title>Placebo/Risankizumab 150 mg (Part B)</title>
          <description>Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="E6">
          <title>Risankizumab 75 mg/Risankizumab 75 mg (Part B)</title>
          <description>Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
        <group group_id="E7">
          <title>Risankizumab 150 mg/Risankizumab 150 mg (Part B)</title>
          <description>Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 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="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rectal polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Erythrodermic psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 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="22" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </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="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="58"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="55"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E5" events="12" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E6" events="13" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E7" events="12" subjects_affected="11" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </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="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Asteatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="58"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </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/NCT03000075
org study id: M16-004
secondary id: 1311.38
nct id: NCT03000075
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized double blind, double dummy, placebo controlled, parallel design study
      that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
Participants were randomized to receive either placebo, risankizumab 75 mg, or risankizumab
      150 mg in Part A. All participants received 2 injections to maintain the blind: the placebo
      arm received 2 injections of placebo, the risankizumab 75 mg arm received one injection of
      risankizumab 75 mg and one injection of placebo, and the risankizumab 150 mg arm received 2
      injections of risankizumab 75 mg. Participants who received placebo in Part A switched to
      risankizumab in Part B; participants who received risankizumab (75 mg or 150 mg) in Part A
      continued to receive the same treatment (risankizumab 75 mg or 150 mg) in Part B.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving PASI90 at Week 52 (Part B)
time frame: Week 52
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)
time frame: Week 52
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving PASI75 at Week 52 (Part B)
time frame: Week 52
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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)
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 a 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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants Achieving PASI100 at Week 52 (Part B)
time frame: Week 52
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 a 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. Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)
time frame: Week 16
description: Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
measure: Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)
time frame: Week 52
description: Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
description: Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
arm group label: Risankizumab 75 mg (Part A)
arm group type: Experimental
description: Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
arm group label: Risankizumab 150 mg (Part A)
arm group type: Experimental
description: Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
intervention type: Drug
intervention name: risankizumab
description: Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
arm group label: Risankizumab 150 mg (Part A)
arm group label: Risankizumab 75 mg (Part A)
other name: ABBV-066
other name: BI 655066
intervention type: Drug
intervention name: placebo for risankizumab
description: Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
arm group label: Placebo (Part A)
arm group label: Risankizumab 75 mg (Part A)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
country: Japan
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Antibodies, Monoclonal
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 