<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/NCT04435600</url>
  </required_header>
  <id_info>
    <org_study_id>M19-977</org_study_id>
    <secondary_id>2019-004141-32</secondary_id>
    <nct_id>NCT04435600</nct_id>
  </id_info>
  <brief_title>A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms</brief_title>
  <acronym>OptIMMize-1</acronym>
  <official_title>A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and&#xD;
      develop thick, red and white scaly patches on the skin. There is an unmet medical need for&#xD;
      effective treatment in pediatric patients and this study is being done to evaluate&#xD;
      risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study&#xD;
      will assess the change in disease symptoms.&#xD;
&#xD;
      Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric&#xD;
      participants. This study has 4 parts.&#xD;
&#xD;
      Part 1: Participants aged 12 &lt; 18 will receive a fixed dose of risankizumab. Part 2:&#xD;
      Participants aged 12 &lt; 18 will receive;&#xD;
&#xD;
        -  Period A: Risankizumab or ustekinumab based on body weight followed by;&#xD;
&#xD;
        -  Period B: Risankizumab or no treatment.&#xD;
&#xD;
        -  Period C: Re-treatment with risankizumab (if needed).&#xD;
&#xD;
      Part 3: Participants aged 6 &lt; 12 will receive risankizumab based on body weight.&#xD;
&#xD;
      Part 4: Participants aged 6 &lt; 12 will receive risankizumab based on body weight (Japan only:&#xD;
      Participants aged 12 &gt; 18 will receive risankizumab based on body weight).&#xD;
&#xD;
      Around 132 participants will be enrolled in approximately 50 sites worldwide.&#xD;
&#xD;
      Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.&#xD;
&#xD;
      Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study&#xD;
      duration of approximately 65 weeks.&#xD;
&#xD;
      Part 2:&#xD;
&#xD;
        -  Period A: Risankizumab or ustekinumab for 16 weeks.&#xD;
&#xD;
        -  Period B: Risankizumab or no treatment for 36 weeks.&#xD;
&#xD;
        -  Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for&#xD;
           a study duration of approximately 81 weeks. Participants from each Part who meet&#xD;
           eligibility criteria for an open-label extension (OLE) study may continue on&#xD;
           risankizumab for 216 additional weeks.&#xD;
&#xD;
      There may be a higher burden for study participants compared to standard treatment.&#xD;
      Participants will attend monthly visits and medical assessments will check the effect of&#xD;
      treatment through blood tests, questionnaires, and checking for side effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">August 7, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 11, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear</measure>
    <time_frame>At Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline</measure>
    <time_frame>At Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)</time_frame>
    <description>The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)</time_frame>
    <description>The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 in Part 2 (Period A)</time_frame>
    <description>The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Change in CDLQI</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI)</measure>
    <time_frame>Baseline (Week 0) to Week 16 in Part 2 (Period A)</time_frame>
    <description>The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Change in FDLQI</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS)</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing &quot;no itching&quot; and 10, representing &quot;worst itch imaginable.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period C): Change in Itch NRS</measure>
    <time_frame>Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)</time_frame>
    <description>The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing &quot;no itching&quot; and 10, representing &quot;worst itch imaginable.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (Period A): Percentage of Participants Achieving &gt; = 4-point Improvement in the Itch Numerical Rating Scale (in Participants with Baseline Score &gt; = 4) at Each Study Visit</measure>
    <time_frame>Baseline (Week 0) to Week 16 in Part 2 (Period A)</time_frame>
    <description>The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing &quot;no itching&quot; and 10, representing &quot;worst itch imaginable.&quot;</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Part 1: Risankizumab Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants age 12 to less than 18 will receive:&#xD;
Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4).&#xD;
Period B: Risankizumab Dose A or B based on body weight for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Risankizumab Dose A/B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants age 12 to less than 18 will receive:&#xD;
Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).&#xD;
Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare.&#xD;
Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: Risankizumab Dose A/B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4: Risankizumab Dose A/B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risankizumab</intervention_name>
    <description>Subcutaneous Injection</description>
    <arm_group_label>Part 1: Risankizumab Dose A</arm_group_label>
    <arm_group_label>Part 2: Risankizumab Dose A/B</arm_group_label>
    <arm_group_label>Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B</arm_group_label>
    <arm_group_label>Part 3: Risankizumab Dose A/B</arm_group_label>
    <arm_group_label>Part 4: Risankizumab Dose A/B</arm_group_label>
    <other_name>SKYRIZI</other_name>
    <other_name>ABBV-066</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <description>Subcutaneous Injection</description>
    <arm_group_label>Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.&#xD;
&#xD;
          -  Stable severe or moderate to severe plaque psoriasis as defined in each study part by&#xD;
             body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and&#xD;
             Severity Index (PASI) and Static Physician Global Assessment (sPGA).&#xD;
&#xD;
          -  Candidate for systemic therapy as assessed by the investigator and meet the disease&#xD;
             activity criteria at both the Screening and Baseline Visits per the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Concurrent clinically significant medical conditions other than the indication being&#xD;
        studied or any other reason that the investigator determines would interfere with the&#xD;
        participant's participation in this study, would make the participant an unsuitable&#xD;
        candidate to receive study drug, or would put the participant at risk by participating in&#xD;
        the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ABBVIE CALL CENTER</last_name>
    <phone>844-663-3742</phone>
    <email>abbvieclinicaltrials@abbvie.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UAB Department of Dermatology /ID# 218834</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>First OC Dermatology Research Inc /ID# 217733</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708-3701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Integrative Skin Science and Research /ID# 221741</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital San Diego /ID# 217906</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rybear, Inc /ID# 223164</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316-1952</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Solutions Through Adv Rch /ID# 217936</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research- St. Petersburg /ID# 217941</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709-1405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Institute /ID# 222706</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Dermatology and Vein Clinic, LLC /ID# 222778</name>
      <address>
        <city>Darien</city>
        <state>Illinois</state>
        <zip>60561</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Arlington Dermatology /ID# 217472</name>
      <address>
        <city>Rolling Meadows</city>
        <state>Illinois</state>
        <zip>60008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Skin Cancer and Dermatology Institute (SCDI) /ID# 221738</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Forest Hills Dermatology Group /ID# 227941</name>
      <address>
        <city>Kew Gardens</city>
        <state>New York</state>
        <zip>11415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Univ Hosp Cleveland /ID# 228483</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University /ID# 217808</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Apex Dermatology &amp; Skin Surgery Center /ID# 228537</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124-6509</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vital Prospects Clinical Research Institute, PC /ID# 217960</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136-7049</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina /ID# 217735</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Arlington Research Center, Inc /ID# 217471</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals /ID# 228352</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Specialist, Inc - Kenosha /ID# 223161</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53144-1782</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin /ID# 240005</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226-3522</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dermatology Research Institute Inc. /ID# 226172</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2J 7E1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Karma Clinical Trials /ID# 226177</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1A 4Y3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children /ID# 226167</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine /ID# 226170</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Muenster /ID# 225988</name>
      <address>
        <city>Munster</city>
        <state>Niedersachsen</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fachklinik Bad Bentheim /ID# 226014</name>
      <address>
        <city>Bad Bentheim</city>
        <zip>48455</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn /ID# 228880</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital /ID# 230830</name>
      <address>
        <city>Nagoya shi</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital /ID# 230836</name>
      <address>
        <city>Tsu-shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital /ID# 231215</name>
      <address>
        <city>Hirakata-shi</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital /ID# 255188</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital /ID# 230575</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dermed Centrum Medyczne Sp. z o.o /ID# 226062</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>90-265</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dermoklinika Centrum Medyczne s.c. /ID# 226063</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>High-Med Przychodnia Specjalistyczna /ID# 226060</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-817</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116</name>
      <address>
        <city>Rzeszow</city>
        <state>Podkarpackie</state>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Deu /ID# 225722</name>
      <address>
        <city>Esplugues de Llobregat</city>
        <state>Barcelona</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon /ID# 225721</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor /ID# 225720</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 227860</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Pontevedra /ID# 226061</name>
      <address>
        <city>Pontevedra</city>
        <zip>36071</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Devon University Healthcare NHS Foundation Trust /ID# 228078</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Foundation Trust /ID# 227224</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde /ID# 227226</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G12 0XH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Frimley Health NHS Foundation Trust /ID# 229525</name>
      <address>
        <city>Camberley</city>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Plymouth NHS Trust /ID# 227230</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 5FP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=M19-977</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plaque Psoriasis</keyword>
  <keyword>Risankizumab</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>Psoriasis</keyword>
  <keyword>Biologic</keyword>
  <keyword>ABBV-066</keyword>
  <keyword>SKYRIZI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, 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_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04435600
org study id: M19-977
secondary id: 2019-004141-32
nct id: NCT04435600
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and
      develop thick, red and white scaly patches on the skin. There is an unmet medical need for
      effective treatment in pediatric patients and this study is being done to evaluate
      risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study
      will assess the change in disease symptoms.

      Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric
      participants. This study has 4 parts.

      Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2:
      Participants aged 12 < 18 will receive;

        -  Period A: Risankizumab or ustekinumab based on body weight followed by;

        -  Period B: Risankizumab or no treatment.

        -  Period C: Re-treatment with risankizumab (if needed).

      Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight.

      Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only:
      Participants aged 12 > 18 will receive risankizumab based on body weight).

      Around 132 participants will be enrolled in approximately 50 sites worldwide.

      Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.

      Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study
      duration of approximately 65 weeks.

      Part 2:

        -  Period A: Risankizumab or ustekinumab for 16 weeks.

        -  Period B: Risankizumab or no treatment for 36 weeks.

        -  Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for
           a study duration of approximately 81 weeks. Participants from each Part who meet
           eligibility criteria for an open-label extension (OLE) study may continue on
           risankizumab for 216 additional weeks.

      There may be a higher burden for study participants compared to standard treatment.
      Participants will attend monthly visits and medical assessments will check the effect of
      treatment through blood tests, questionnaires, and checking for side effects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear
time frame: At Week 16 of each part of the study (Parts 1-4)
description: The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
measure: US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline
time frame: At Week 16 of each part of the study (Parts 1-4)
description: The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
measure: Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear
time frame: Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
description: The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
measure: Part 2 (Period C): US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline
time frame: Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
description: The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
measure: Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
measure: Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI)
time frame: Baseline (Week 0) to Week 16 in Part 2 (Period A)
description: The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL).
measure: Part 2 (Period C): Change in CDLQI
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL.
measure: Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI)
time frame: Baseline (Week 0) to Week 16 in Part 2 (Period A)
description: The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.
measure: Part 2 (Period C): Change in FDLQI
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.
measure: Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS)
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
measure: Part 2 (Period C): Change in Itch NRS
time frame: Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
description: The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
measure: Part 2 (Period A): Percentage of Participants Achieving > = 4-point Improvement in the Itch Numerical Rating Scale (in Participants with Baseline Score > = 4) at Each Study Visit
time frame: Baseline (Week 0) to Week 16 in Part 2 (Period A)
description: The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
arm group label: Part 1: Risankizumab Dose A
arm group type: Experimental
description: Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
arm group label: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
arm group type: Experimental
description: Participants age 12 to less than 18 will receive:
Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Risankizumab Dose A or B based on body weight for 24 weeks.
arm group label: Part 2: Risankizumab Dose A/B
arm group type: Experimental
description: Participants age 12 to less than 18 will receive:
Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare.
Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
arm group label: Part 3: Risankizumab Dose A/B
arm group type: Experimental
description: Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
arm group label: Part 4: Risankizumab Dose A/B
arm group type: Experimental
description: Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).
intervention type: Drug
intervention name: Risankizumab
description: Subcutaneous Injection
arm group label: Part 1: Risankizumab Dose A
arm group label: Part 2: Risankizumab Dose A/B
arm group label: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
arm group label: Part 3: Risankizumab Dose A/B
arm group label: Part 4: Risankizumab Dose A/B
other name: SKYRIZI
other name: ABBV-066
intervention type: Drug
intervention name: Ustekinumab
description: Subcutaneous Injection
arm group label: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: ABBVIE CALL CENTER
phone: 844-663-3742
email: abbvieclinicaltrials@abbvie.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Canada
country: Germany
country: Japan
country: Poland
country: Spain
country: United Kingdom
country: United States
url: https://www.abbvieclinicaltrials.com/study/?id=M19-977
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Ustekinumab
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, analyses plans, 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 time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/