<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/NCT02203851</url>
  </required_header>
  <id_info>
    <org_study_id>M16-009</org_study_id>
    <secondary_id>2014-001687-36</secondary_id>
    <secondary_id>1311.13</secondary_id>
    <nct_id>NCT02203851</nct_id>
  </id_info>
  <brief_title>Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis</brief_title>
  <official_title>An Open Label Extension Trial Assessing the Safety and Efficacy of BI 655066/ ABBV-066/Risankizumab Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of Study M16-009 was to investigate the safety of risankizumab in&#xD;
      participants with moderate to severe chronic plaque psoriasis who were receiving long-term&#xD;
      treatment. Additional study objectives were to further investigate the long-term efficacy,&#xD;
      tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who had successfully completed Study 1311.2 (NCT02054481; the lead-in study) and&#xD;
      met the eligibility criteria for Study M16-009 (extension study) had the option to enter the&#xD;
      extension study. Participants were allowed to have the End of Study Visit in the lead in&#xD;
      study combined with the Week 0 Visit for the extension study. At the Week 12 visit,&#xD;
      participants were assigned to treatment based on 90% improvement in Psoriasis Area and&#xD;
      Severity Index (PASI90) Score: participants with ≥PASI90 Score at Week 12 continued to&#xD;
      receive risankizumab 90 mg by subcutaneous (SC) injection; participants with &lt;PASI90 Score at&#xD;
      Week 12 switched to risankizumab 180 mg by SC injection.&#xD;
&#xD;
      Efficacy results are summarized by the 4 treatment groups from the lead-in study, which&#xD;
      included the following: Participants who received risankizumab 18 mg in the lead-in study and&#xD;
      risankizumab in the extension study (Risankizumab 18 mg/Risankizumab); participants who&#xD;
      received risankizumab 90 mg in the lead-in study and risankizumab in the extension study&#xD;
      (Risankizumab 90 mg/Risankizumab); participants who received risankizumab 180 mg in the&#xD;
      lead-in study and risankizumab in the extension study (Risankizumab 180 mg/Risankizumab); and&#xD;
      participants who received ustekinumab (Stelara) 45 or 90 mg in the lead-in study and&#xD;
      risankizumab in the extension study (Ustekinumab/Risankizumab).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2014</start_date>
  <completion_date type="Actual">September 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 4, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Drug-related TEAEs</measure>
    <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period</measure>
    <time_frame>Week 48</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period</measure>
    <time_frame>Baseline, Week 48</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period</measure>
    <time_frame>Baseline, Week 48</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period</measure>
    <time_frame>Week 48</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Risankizumab 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved ≥90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 continued to receive open-label (OL) risankizumab 90 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risankizumab 180 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved &lt;90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 switched to open-label (OL) risankizumab 180 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risankizumab</intervention_name>
    <description>Risankizumab administered by subcutaneous (SC) injection</description>
    <arm_group_label>Risankizumab 180 mg</arm_group_label>
    <arm_group_label>Risankizumab 90 mg</arm_group_label>
    <other_name>BI 655066</other_name>
    <other_name>ABBV-066</other_name>
    <other_name>SKYRIZI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Participants with moderate to severe chronic plaque psoriasis, who have successfully&#xD;
             completed Study 1311.2 (NCT02054481; the lead-in study). Successful completion of the&#xD;
             lead-in study is defined as either of the following:&#xD;
&#xD;
               1. Completion of the entire follow up period, thus reaching End-of-study (EOS)&#xD;
                  visit.&#xD;
&#xD;
               2. Loss of response, defined as decrease in response to achieving &lt; 50% improvement&#xD;
                  in Psoriasis Area and Severity Index Score (PASI50) at any time from Week 24.&#xD;
&#xD;
          -  Participant must give informed consent and sign an approved consent form prior to any&#xD;
             study procedures in accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
          -  Applicable only for female participants:&#xD;
&#xD;
          -  Negative urine pregnancy dip stick test at the roll-over visit, and if available at&#xD;
             roll-over visit, negative Serum ß-Human Chorionic Gonadotropin (ß-HCG) test.&#xD;
&#xD;
        In addition:&#xD;
&#xD;
        Women of childbearing potential (not surgically sterilized and between menarche and 1 year&#xD;
        postmenopausal), that, if sexually active agree to use one of the appropriate medically&#xD;
        accepted methods of birth control in addition to the consistent and correct use of a condom&#xD;
        from date of the roll-over visit until 12 weeks after last treatment in this study.&#xD;
        Medically accepted methods of contraception are: ethinyl estradiol containing&#xD;
        contraceptives, diaphragm with spermicide substance, and intra-uterine-device.&#xD;
&#xD;
        OR&#xD;
&#xD;
        Female participants which have vasectomized sexual partner(s) (vasectomy at least 1 year&#xD;
        prior to enrollment).&#xD;
&#xD;
        OR&#xD;
&#xD;
        Surgically sterilized female participants with documentation of prior hysterectomy, tubal&#xD;
        ligation or complete bilateral oophorectomy.&#xD;
&#xD;
        OR&#xD;
&#xD;
        Postmenopausal women with postmenopausal is defined as permanent cessation ≥ 1 year of&#xD;
        previously occurring menses.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participants who experienced any drug related serious adverse event (SAE) in the&#xD;
             lead-in study&#xD;
&#xD;
          -  Participants who have developed guttate, erythrodermic or pustular psoriasis or&#xD;
             drug-induced psoriasis (as diagnosed by the investigator), during the lead-in study.&#xD;
&#xD;
          -  Evidence of current or previous clinically significant disease, medical condition&#xD;
             other than psoriasis, or finding of the medical examination (including vital signs and&#xD;
             electrocardiography [ECG]), that in the opinion of the investigator, would compromise&#xD;
             the safety of the participant or the quality of the data.&#xD;
&#xD;
          -  Known clinically important acute or chronic infections including hepatitis, human&#xD;
             immunodeficiency virus (HIV). In regards to tuberculosis (TB), the following applies:&#xD;
&#xD;
          -  Signs or symptoms suggestive of current active or latent TB upon medical history,&#xD;
             physical examination and/or a chest radiograph (both posterior-anterior and lateral&#xD;
             views, taken within 3 months prior to the first administration of study drug and read&#xD;
             by a qualified radiologist).&#xD;
&#xD;
          -  History of latent or active TB prior to screening, except for participants with&#xD;
             documented completion of an adequate treatment regimen, at least 6 months prior to the&#xD;
             first administration of study agent.&#xD;
&#xD;
          -  Positive QuantiFERON-TB Gold In-Tube test (IGRA) within 2 months prior to the&#xD;
             roll-over visit (if available), in which active TB has not been ruled out. This does&#xD;
             not apply to participants with history of latent TB with documented completion of an&#xD;
             adequate treatment regimen, at least 6 months prior to the first administration of&#xD;
             study agent.&#xD;
&#xD;
          -  Participants who have developed malignancy, or suspicion of active malignant disease&#xD;
             during the lead-in study (except treated cutaneous squamous cell or basal cell&#xD;
             carcinoma or carcinoma in situ of the cervix that have been adequately treated).&#xD;
&#xD;
          -  Intake of restricted medications or other drugs considered likely to interfere with&#xD;
             the safe conduct of this study, as assessed by the investigator.&#xD;
&#xD;
          -  Alcohol or drug abuse within 3 months prior to the roll-over visit that would&#xD;
             interfere with trial participation or any ongoing condition leading to a decreased&#xD;
             compliance to study procedures in the opinion of the investigator.&#xD;
&#xD;
          -  Any clinically significant laboratory abnormalities based on the last available&#xD;
             laboratory results received during the lead-in study (according to the investigator's&#xD;
             medical assessment).&#xD;
&#xD;
          -  Pre-menopausal woman who is pregnant or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>May 10, 2019</results_first_submitted>
  <results_first_submitted_qc>October 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2019</results_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BI 655066</keyword>
  <keyword>risankizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02203851/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02203851/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Analyses were performed using the intent-to-treat (ITT) population defined as all participants who received at least 1 dose of study drug. As predefined, the demographics, disposition and safety results were summarized for ITT population. Efficacy results were summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).</recruitment_details>
      <pre_assignment_details>Participants completing lead-in study and met eligibility for this study were enrolled; demographic/disposition were not collected by dose level. Some participants in extension study had dose escalation due to lack of efficacy, predefined selected safety analysis were broken down by groups: participants remaining at 90mg and those receiving 180mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Risankizumab 90 mg or 180 mg</title>
          <description>Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) Population: All participants that received at least one dose of study drug in the extension study who either remained at 90 mg throughout the study or who received 180 mg were summarized.</population>
      <group_list>
        <group group_id="B1">
          <title>Risankizumab 90 mg or 180 mg</title>
          <description>Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
          </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="49.0" spread="13.04"/>
                  </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="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
        <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
        <population>Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 90 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 180 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had &lt; PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
          <population>Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Drug-related TEAEs</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
        <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
        <population>Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 90 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 180 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had &lt; PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Drug-related TEAEs</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
          <population>Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
        <time_frame>From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)</time_frame>
        <population>Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 90 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 180 mg</title>
            <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had &lt; PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.</description>
          <population>Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period</title>
        <description>Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period</title>
          <description>Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
          <population>ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7" lower_limit="54.1" upper_limit="91.3"/>
                    <measurement group_id="O2" value="77.8" lower_limit="62.1" upper_limit="93.5"/>
                    <measurement group_id="O3" value="71.9" lower_limit="56.3" upper_limit="87.5"/>
                    <measurement group_id="O4" value="74.1" lower_limit="57.5" upper_limit="90.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT Population summarized by the 4 treatment groups from the lead-in study</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
          <population>ITT Population summarized by the 4 treatment groups from the lead-in study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="43.5" upper_limit="83.7"/>
                    <measurement group_id="O2" value="70.4" lower_limit="53.1" upper_limit="87.6"/>
                    <measurement group_id="O3" value="68.8" lower_limit="52.7" upper_limit="84.8"/>
                    <measurement group_id="O4" value="66.7" lower_limit="48.9" upper_limit="84.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeksfor approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
          <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" lower_limit="86.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="96.3" lower_limit="89.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
          <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.4" lower_limit="72.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="92.6" lower_limit="82.7" upper_limit="100.0"/>
                    <measurement group_id="O3" value="90.6" lower_limit="80.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="96.3" lower_limit="89.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period</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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.</description>
          <population>ITT population summarized by the 4 treatment groups from the lead-in study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" lower_limit="33.7" upper_limit="75.4"/>
                    <measurement group_id="O2" value="55.6" lower_limit="36.8" upper_limit="74.3"/>
                    <measurement group_id="O3" value="50.0" lower_limit="32.7" upper_limit="67.3"/>
                    <measurement group_id="O4" value="55.6" lower_limit="36.8" upper_limit="74.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT Population summarized by the 4 treatment groups from the lead-in study</population>
        <group_list>
          <group group_id="O1">
            <title>Risankizumab 18 mg/Risankizumab</title>
            <description>Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O2">
            <title>Risankizumab 90 mg/Risankizumab</title>
            <description>Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O3">
            <title>Risankizumab 180 mg/Risankizumab</title>
            <description>Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab/Risankizumab</title>
            <description>Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period</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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.</description>
          <population>ITT Population summarized by the 4 treatment groups from the lead-in study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" lower_limit="33.7" upper_limit="75.4"/>
                    <measurement group_id="O2" value="63.0" lower_limit="44.7" upper_limit="81.2"/>
                    <measurement group_id="O3" value="56.3" lower_limit="39.1" upper_limit="73.4"/>
                    <measurement group_id="O4" value="55.6" lower_limit="36.8" upper_limit="74.3"/>
                  </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 in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Risankizumab 90 mg</title>
          <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
        </group>
        <group group_id="E2">
          <title>Risankizumab 180 mg</title>
          <description>Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had &lt; PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Macular degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Ulnar neuritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="33" subjects_affected="16" subjects_at_risk="87"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="87"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </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="10" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </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="2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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/NCT02203851
org study id: M16-009
secondary id: 2014-001687-36
secondary id: 1311.13
nct id: NCT02203851
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of Study M16-009 was to investigate the safety of risankizumab in
      participants with moderate to severe chronic plaque psoriasis who were receiving long-term
      treatment. Additional study objectives were to further investigate the long-term efficacy,
      tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
Participants who had successfully completed Study 1311.2 (NCT02054481; the lead-in study) and
      met the eligibility criteria for Study M16-009 (extension study) had the option to enter the
      extension study. Participants were allowed to have the End of Study Visit in the lead in
      study combined with the Week 0 Visit for the extension study. At the Week 12 visit,
      participants were assigned to treatment based on 90% improvement in Psoriasis Area and
      Severity Index (PASI90) Score: participants with ≥PASI90 Score at Week 12 continued to
      receive risankizumab 90 mg by subcutaneous (SC) injection; participants with <PASI90 Score at
      Week 12 switched to risankizumab 180 mg by SC injection.

      Efficacy results are summarized by the 4 treatment groups from the lead-in study, which
      included the following: Participants who received risankizumab 18 mg in the lead-in study and
      risankizumab in the extension study (Risankizumab 18 mg/Risankizumab); participants who
      received risankizumab 90 mg in the lead-in study and risankizumab in the extension study
      (Risankizumab 90 mg/Risankizumab); participants who received risankizumab 180 mg in the
      lead-in study and risankizumab in the extension study (Risankizumab 180 mg/Risankizumab); and
      participants who received ustekinumab (Stelara) 45 or 90 mg in the lead-in study and
      risankizumab in the extension study (Ustekinumab/Risankizumab).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
measure: Number of Participants With Drug-related TEAEs
time frame: From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period
time frame: Baseline, Week 48
description: Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period
time frame: Week 48
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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
measure: Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period
time frame: Baseline, Week 48
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
measure: Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period
time frame: Baseline, Week 48
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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
measure: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period
time frame: Baseline, Week 48
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. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
measure: Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period
time frame: Week 48
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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
arm group label: Risankizumab 90 mg
arm group type: Experimental
description: Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved ≥90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 continued to receive open-label (OL) risankizumab 90 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
arm group label: Risankizumab 180 mg
arm group type: Experimental
description: Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved <90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 switched to open-label (OL) risankizumab 180 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
intervention type: Drug
intervention name: Risankizumab
description: Risankizumab administered by subcutaneous (SC) injection
arm group label: Risankizumab 180 mg
arm group label: Risankizumab 90 mg
other name: BI 655066
other name: ABBV-066
other name: SKYRIZI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
country: Canada
country: France
country: Germany
country: United States
url: http://www.rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 