xml: <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/NCT05995353</url>
    </required_header>
    <id_info>
      <org_study_id>M16-194</org_study_id>
      <secondary_id>2022-502050-14-00</secondary_id>
      <nct_id>NCT05995353</nct_id>
    </id_info>
    <brief_title>A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease</brief_title>
    <official_title>A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to &lt; 18 Years of Age) With Moderately to Severely Active Crohn's Disease</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or&#xD;
        without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the&#xD;
        pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with&#xD;
        moderately to severely active CD aged 2 to &lt; 18 years old who have had intolerance or&#xD;
        inadequate response to other therapies.&#xD;
  &#xD;
        Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and&#xD;
        CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3&#xD;
        cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with&#xD;
        ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less&#xD;
        than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1&#xD;
        is an open-label induction period where participants will receive a weight-based induction&#xD;
        regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be&#xD;
        randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is&#xD;
        an open-label extension period where participants will receive risankizumab based off of&#xD;
        their response in SS2. Around 110 pediatric participants with CD will be enrolled at around&#xD;
        100 sites worldwide.&#xD;
  &#xD;
        Participants in SS1 will receive risankizumab intravenously during the 12-week induction&#xD;
        period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week&#xD;
        randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously&#xD;
        during the 208-week open label period. Participants will be followed-up for approximately 140&#xD;
        days.&#xD;
  &#xD;
        There may be higher treatment burden for participants in this trial compared to their&#xD;
        standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,&#xD;
        checking for side effects and completing questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">April 8, 2029</completion_date>
    <primary_completion_date type="Anticipated">April 8, 2029</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD &gt; 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohorts 1 &amp; 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab</measure>
      <time_frame>Up to approximately Week 64</time_frame>
      <description>Cmax of risankizumab</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohorts 1 &amp; 2: Time to Cmax (Tmax) of Risankizumab</measure>
      <time_frame>Up to approximately 64 weeks</time_frame>
      <description>Tmax of risankizumab</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohorts 1 &amp; 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab</measure>
      <time_frame>Up to approximately 64 weeks</time_frame>
      <description>AUCtau of risankizumab</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD &gt; 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score &gt; 1, as scored by a central reader.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score &gt; 1, as scored by a central reader.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD &gt; 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD &gt; 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score &gt; 1, as scored by a central reader.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score &gt; 1, as scored by a central reader.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 &amp; 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI</measure>
      <time_frame>At 64 weeks</time_frame>
      <description>PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.</description>
    </secondary_outcome>
    <number_of_arms>15</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Crohn's Disease</condition>
    <arm_group>
      <arm_group_label>PK Cohort 1: SS1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1 will consist of 2 age groups (6 to &lt; 12 years and 12 to &lt; 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 1: SS2 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1 will consist of 2 age groups (6 to &lt; 12 years and 12 to &lt; 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 1: SS2 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1 will consist of 2 age groups (6 to &lt; 12 years and 12 to &lt; 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 1: SS3 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1 will consist of 2 age groups (6 to &lt; 12 years and 12 to &lt; 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 1: SS3 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1 will consist of 2 age groups (6 to &lt; 12 years and 12 to &lt; 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 2: SS1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 2: SS2 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 2: SS2 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 2: SS3 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PK Cohort 2: SS3 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expansion Cohort 3: SS1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expansion Cohort 3: SS2 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expansion Cohort 3: SS2 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expansion Cohort 3: SS3 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Expansion Cohort 3: SS3 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Risankizumab</intervention_name>
      <description>Intravenous (IV) Infusion</description>
      <arm_group_label>Expansion Cohort 3: SS1</arm_group_label>
      <arm_group_label>PK Cohort 1: SS1</arm_group_label>
      <arm_group_label>PK Cohort 2: SS1</arm_group_label>
      <other_name>ABBV-066</other_name>
      <other_name>SKYRIZI</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Risankizumab</intervention_name>
      <description>Subcutaneous (SC) Injection</description>
      <arm_group_label>Expansion Cohort 3: SS2 Dose A</arm_group_label>
      <arm_group_label>Expansion Cohort 3: SS2 Dose B</arm_group_label>
      <arm_group_label>Expansion Cohort 3: SS3 Dose A</arm_group_label>
      <arm_group_label>Expansion Cohort 3: SS3 Dose B</arm_group_label>
      <arm_group_label>PK Cohort 1: SS2 Dose A</arm_group_label>
      <arm_group_label>PK Cohort 1: SS2 Dose B</arm_group_label>
      <arm_group_label>PK Cohort 1: SS3 Dose A</arm_group_label>
      <arm_group_label>PK Cohort 1: SS3 Dose B</arm_group_label>
      <arm_group_label>PK Cohort 2: SS2 Dose A</arm_group_label>
      <arm_group_label>PK Cohort 2: SS2 Dose B</arm_group_label>
      <arm_group_label>PK Cohort 2: SS3 Dose A</arm_group_label>
      <arm_group_label>PK Cohort 2: SS3 Dose B</arm_group_label>
      <other_name>ABBV-066</other_name>
      <other_name>SKYRIZI</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pediatric individuals, 2 to &lt; 18 years old&#xD;
  &#xD;
            -  Must have moderately to severely active CD, as defined by the PCDAI score &gt; 30&#xD;
               assessed at Baseline&#xD;
  &#xD;
            -  Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥&#xD;
               6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)&#xD;
  &#xD;
            -  Demonstrated intolerance or inadequate response to one or more of the following&#xD;
               categories of drugs: aminosalicylates, oral locally acting corticosteroids, systemic&#xD;
               steroids (prednisone or equivalent), IMMs, and/or biologic therapies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of an allergic reaction or significant sensitivity to constituents of the&#xD;
               study drug (and its excipients) and/or other products in the same class&#xD;
  &#xD;
            -  Any of the following medical disorders:&#xD;
  &#xD;
                 1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.&#xD;
  &#xD;
                 2. A diagnosis of CD prior to 2 years of age.&#xD;
  &#xD;
                 3. A diagnosis or suspected diagnosis of a primary immunodeficiency.&#xD;
  &#xD;
                 4. Currently known complications of CD such as:&#xD;
  &#xD;
                      -  Active abscess (abdominal or perianal);&#xD;
  &#xD;
                      -  Symptomatic bowel strictures;&#xD;
  &#xD;
                      -  &gt; 2 missing segments of the following 5 segments: terminal ileum, right&#xD;
                         colon, transverse colon, sigmoid and left colon, and rectum;&#xD;
  &#xD;
                      -  Fulminant colitis;&#xD;
  &#xD;
                      -  Toxic megacolon;&#xD;
  &#xD;
                      -  Or any other manifestation that might require surgery while enrolled in the&#xD;
                         study.&#xD;
  &#xD;
                 5. Ostomy or ileoanal pouch.&#xD;
  &#xD;
                 6. Diagnosis of short gut or short bowel syndrome.&#xD;
  &#xD;
                 7. Surgical bowel resection within the past 3 months prior to Baseline (excluding&#xD;
                    gastrointestinal surgeries which are not bowel resections such as appendectomy or&#xD;
                    ostomy closure), or a history of &gt;3 bowel resections.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 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>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M16-194</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Crohn's Disease</keyword>
    <keyword>Risankizumab</keyword>
    <keyword>Skyrizi</keyword>
    <keyword>Pediatrics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <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>
  
  
text: 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/NCT05995353
  org study id: M16-194
  secondary id: 2022-502050-14-00
  nct id: NCT05995353
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or
        without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the
        pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with
        moderately to severely active CD aged 2 to < 18 years old who have had intolerance or
        inadequate response to other therapies.
  
        Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and
        CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3
        cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with
        ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less
        than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1
        is an open-label induction period where participants will receive a weight-based induction
        regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be
        randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is
        an open-label extension period where participants will receive risankizumab based off of
        their response in SS2. Around 110 pediatric participants with CD will be enrolled at around
        100 sites worldwide.
  
        Participants in SS1 will receive risankizumab intravenously during the 12-week induction
        period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week
        randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously
        during the 208-week open label period. Participants will be followed-up for approximately 140
        days.
  
        There may be higher treatment burden for participants in this trial compared to their
        standard of care. Participants will attend regular visits during the study at a hospital or
        clinic. The effect of the treatment will be checked by medical assessments, blood tests,
        checking for side effects and completing questionnaires.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
  time frame: At 64 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
  measure: Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
  time frame: At 64 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  measure: Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
  time frame: Up to approximately Week 64
  description: Cmax of risankizumab
  measure: Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
  time frame: Up to approximately 64 weeks
  description: Tmax of risankizumab
  measure: Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
  time frame: Up to approximately 64 weeks
  description: AUCtau of risankizumab
  measure: Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
  time frame: At 12 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
  measure: Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
  time frame: At 12 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  measure: Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
  time frame: At 12 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
  measure: Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
  time frame: At 64 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
  measure: Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
  time frame: At 64 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
  measure: Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
  time frame: At 64 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
  measure: Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
  time frame: At 64 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  measure: Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
  time frame: At 12 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
  measure: Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
  time frame: At 12 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  measure: Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
  time frame: At 12 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
  measure: Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
  time frame: At 64 weeks
  description: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
  measure: Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
  time frame: At 64 weeks
  description: PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
  arm group label: PK Cohort 1: SS1
  arm group type: Experimental
  description: Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
  arm group label: PK Cohort 1: SS2 Dose A
  arm group type: Experimental
  description: Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: PK Cohort 1: SS2 Dose B
  arm group type: Experimental
  description: Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: PK Cohort 1: SS3 Dose A
  arm group type: Experimental
  description: Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  arm group label: PK Cohort 1: SS3 Dose B
  arm group type: Experimental
  description: Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  arm group label: PK Cohort 2: SS1
  arm group type: Experimental
  description: Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
  arm group label: PK Cohort 2: SS2 Dose A
  arm group type: Experimental
  description: Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: PK Cohort 2: SS2 Dose B
  arm group type: Experimental
  description: Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: PK Cohort 2: SS3 Dose A
  arm group type: Experimental
  description: Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  arm group label: PK Cohort 2: SS3 Dose B
  arm group type: Experimental
  description: Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  arm group label: Expansion Cohort 3: SS1
  arm group type: Experimental
  description: Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
  arm group label: Expansion Cohort 3: SS2 Dose A
  arm group type: Experimental
  description: Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: Expansion Cohort 3: SS2 Dose B
  arm group type: Experimental
  description: Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
  arm group label: Expansion Cohort 3: SS3 Dose A
  arm group type: Experimental
  description: Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  arm group label: Expansion Cohort 3: SS3 Dose B
  arm group type: Experimental
  description: Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
  intervention type: Drug
  intervention name: Risankizumab
  description: Intravenous (IV) Infusion
  arm group label: Expansion Cohort 3: SS1
  arm group label: PK Cohort 1: SS1
  arm group label: PK Cohort 2: SS1
  other name: ABBV-066
  other name: SKYRIZI
  intervention type: Drug
  intervention name: Risankizumab
  description: Subcutaneous (SC) Injection
  arm group label: Expansion Cohort 3: SS2 Dose A
  arm group label: Expansion Cohort 3: SS2 Dose B
  arm group label: Expansion Cohort 3: SS3 Dose A
  arm group label: Expansion Cohort 3: SS3 Dose B
  arm group label: PK Cohort 1: SS2 Dose A
  arm group label: PK Cohort 1: SS2 Dose B
  arm group label: PK Cohort 1: SS3 Dose A
  arm group label: PK Cohort 1: SS3 Dose B
  arm group label: PK Cohort 2: SS2 Dose A
  arm group label: PK Cohort 2: SS2 Dose B
  arm group label: PK Cohort 2: SS3 Dose A
  arm group label: PK Cohort 2: SS3 Dose B
  other name: ABBV-066
  other name: SKYRIZI
  criteria: 
  gender: All
  minimum age: 2 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
  url: https://www.abbvieclinicaltrials.com/study/?id=M16-194
  description: Related Info
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Antibodies, Monoclonal
  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/