<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/NCT03759288</url>
  </required_header>
  <id_info>
    <org_study_id>D5271C00001</org_study_id>
    <secondary_id>#3150-301-008</secondary_id>
    <secondary_id>2018-004346-42</secondary_id>
    <nct_id>NCT03759288</nct_id>
  </id_info>
  <brief_title>An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease</brief_title>
  <acronym>INTREPID</acronym>
  <official_title>A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I)&#xD;
      and versus an active comparator (Stage 2) in participants with moderately to severely active&#xD;
      CD and will include assessments of clinical response as demonstrated by improvement of&#xD;
      symptoms and colonic mucosal appearance as observed on endoscopy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Anticipated">October 13, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 13, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI remission</measure>
    <time_frame>at Week 12</time_frame>
    <description>CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2. Percentage of patients with endoscopic response</measure>
    <time_frame>at Week 52</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with endoscopic response</measure>
    <time_frame>at Week 12</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 12</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI response</measure>
    <time_frame>at Week 12</time_frame>
    <description>CDAI response is defined as achieving the CDAI score of &lt; 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI remission</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI response</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>CDAI response is defined as achieving the CDAI score of &lt; 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with endoscopic response</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with clinical remission</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with endoscopic remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Endoscopic remission is defined as achieving the SES-CD total score of 0-2 OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore &gt; 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI response</measure>
    <time_frame>at Week 52</time_frame>
    <description>CDAI response is defined as achieving the CDAI score of &lt; 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with CDAI remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with endoscopic response</measure>
    <time_frame>at Week 52</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with SES-CD total score of 0-2</measure>
    <time_frame>at Week 52</time_frame>
    <description>SES-CD total score of 0-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with endoscopic response and endoscopic remission</measure>
    <time_frame>Endoscopic response at Week 12, endoscopic remission at Week 52</time_frame>
    <description>Endoscopic response: Minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore &gt; 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Serum concentration of brazikumab</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Pharmacokinetics: concentration of brazikumab in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Incidence of anti-drug antibodies</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Immunogenicity: incidence of brazikumab anti-drug antibodies in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Exposure-response</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2</measure>
    <time_frame>at Week 12</time_frame>
    <description>Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Number and percentage of patients with adverse events</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Number and percentage of patients with reported adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with potentially clinically significant changes in laboratory values</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with potentially clinically significant changes in vital signs</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with potentially clinically significant changes in physical exams</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in full physical exams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1. Percentage of patients with potentially clinically significant changes in ECGs</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with endoscopic response</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Percentage of patients with endoscopic remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Endoscopic remission: - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore &gt; 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Percentage of patients with CS-free endoscopic remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Percentage of patients achieving Endoscopic remission and are CS-free where endoscopic remission is defined as : - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore &gt; 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with CS-free clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Percentage of patients achieving CS-free average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Percentage of patients with CS-free endoscopic remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>For participants taking CS at Baseline, percentage of patients achieving CS-free endoscopic remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Percentage of patients with CS-free clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>For participants taking CS at Baseline, percentage of patients achieving CS-free clinical remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with endoscopic response</measure>
    <time_frame>at Week 12</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 12</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with endoscopic response and endoscopic remission</measure>
    <time_frame>Endoscopic response at Week 12, endoscopic remission at Week 52</time_frame>
    <description>Endoscopic response is defined as minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore &gt; 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at both Week 12 and Week 52</time_frame>
    <description>Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients achieving CS-free endoscopic response</measure>
    <time_frame>at Week 52</time_frame>
    <description>Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with clinical remission</measure>
    <time_frame>at Week 52</time_frame>
    <description>Percentage of patients achieving CS-free clinical remission Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item.(measured by PRO questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Serum concentration of brazikumab</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Pharmacokinetics: concentration of brazikumab in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Incidence of anti-drug antibodies</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Immunogenicity: incidence of brazikumab anti-drug antibodies in blood serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Exposure-response</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Number and percentage of patients with adverse events</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Number and percentage of patients with reported adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with potentially clinically significant changes in laboratory values</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with potentially clinically significant changes in vital signs</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with potentially clinically significant changes in physical exams</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in full physical exams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2. Percentage of patients with potentially clinically significant changes in ECGs</measure>
    <time_frame>Through Week 68</time_frame>
    <description>Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>IBD</condition>
  <arm_group>
    <arm_group_label>(Stage 1) Brazikumab high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Stage 1) Brazikumab low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Stage 1) Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Stage 2) Brazikumab high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Stage 2) Brazikumab low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Stage 2) Humira®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brazikumab low dose</intervention_name>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48</description>
    <arm_group_label>(Stage 1) Brazikumab low dose</arm_group_label>
    <arm_group_label>(Stage 2) Brazikumab low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brazikumab high dose</intervention_name>
    <description>Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48</description>
    <arm_group_label>(Stage 1) Brazikumab high dose</arm_group_label>
    <arm_group_label>(Stage 2) Brazikumab high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humira®</intervention_name>
    <description>Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.</description>
    <arm_group_label>(Stage 2) Humira®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48</description>
    <arm_group_label>(Stage 1) Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however,&#xD;
        participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. At the time of signing the informed consent, the participant must be 18 to 80 years of&#xD;
             age, inclusive.&#xD;
&#xD;
          2. A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a&#xD;
             minimum of 3 months prior to Screening as determined by the investigator based on&#xD;
             clinical history, exclusion of other etiologies including infectious causes, and&#xD;
             characteristic endoscopic and/or histologic findings.&#xD;
&#xD;
          3. Moderately to severely active CD defined by a CDAI score of 220 to 450 AND; CDAI LSF&#xD;
             score ≥ 5 OR CDAI AP score ≥ 2; AND SES-CD of at least 6&#xD;
&#xD;
          4. Participant had an inadequate response or intolerance to intervention with&#xD;
             conventional treatment [oral aminosalicylates, oral CS, azathioprine, methotrexate, or&#xD;
             6-mercaptopurine], or prior biological treatment, or demonstrated CS dependence for&#xD;
             the treatment of CD. For participants who have previously used biological treatment, a&#xD;
             participant may have failed up to 3 biologics that include up to 2 different&#xD;
             mechanisms of action.&#xD;
&#xD;
          5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide,&#xD;
             Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable&#xD;
             dose.&#xD;
&#xD;
          6. Participant must have the QFT-TB test performed and meet the following TB criteria.&#xD;
&#xD;
        A TB worksheet must also be completed:&#xD;
&#xD;
          1. Participant has no known history of active TB.&#xD;
&#xD;
          2. Participant has no known history of latent TB without completion of an appropriate&#xD;
             course of intervention.&#xD;
&#xD;
          3. Meets 1 of the following acceptable TB test results:&#xD;
&#xD;
        i. Negative QFT-TB obtained from central laboratory during Screening, OR ii. For a positive&#xD;
        QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled&#xD;
        out or treated and negative QFT-TB confirmed by central laboratory OR iii. Indeterminate&#xD;
        QFT-TB test obtained during the Screening Period from the central laboratory with ongoing&#xD;
        QFT-TB testing as outlined in Appendix G. Participants with an indeterminate QFT-TB test&#xD;
        can continue with Screening if they have all of the following:&#xD;
&#xD;
          1. no symptoms/risk factors per TB worksheet provided by the sponsor&#xD;
&#xD;
          2. no known recent exposure to a case of active TB&#xD;
&#xD;
          3. no evidence of active TB on chest x-ray within 8 weeks prior to Screening or during&#xD;
             Screening&#xD;
&#xD;
          4. confirmed QFT-TB negative by central laboratory&#xD;
&#xD;
        7 Female participants of childbearing potential must have a negative urine pregnancy test&#xD;
        prior to administration of study intervention and must agree to use a highly effective&#xD;
        method of birth control (confirmed by the investigator) from randomization throughout the&#xD;
        study duration and for at least 18 weeks after last dose of study intervention.&#xD;
&#xD;
        8 Women not of childbearing potential are defined as women who are either permanently&#xD;
        sterilized or who are postmenopausal. Women will be considered postmenopausal if they have&#xD;
        been amenorrhoeic for 12 months prior to the planned date of randomization without an&#xD;
        alternative medical cause.&#xD;
&#xD;
        9 Nonsterilized males who are sexually active with a female partner of childbearing&#xD;
        potential must comply with the methods of contraception during treatment and until the end&#xD;
        of relevant systemic exposure in the male participant, plus a further 18 weeks.&#xD;
&#xD;
        10 Capable of giving signed informed consent, which includes compliance with the&#xD;
        requirements and restrictions listed in the ICF and in the protocol.&#xD;
&#xD;
        11 Willingness and ability to attend all study visits, comply with the study procedures,&#xD;
        read and write in order to complete questionnaires, and be able to complete the study&#xD;
        period.&#xD;
&#xD;
        12 Provision of signed and dated written Optional Genetic Research Information informed&#xD;
        consent prior to collection of samples for optional genetic research that supports Genomic&#xD;
        Initiative.&#xD;
&#xD;
        Complete inclusion criteria are in the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant is unable or unwilling to have endoscopic procedures performed during the&#xD;
             study.&#xD;
&#xD;
          2. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic&#xD;
             colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis,&#xD;
             or untreated bile acid malabsorption.&#xD;
&#xD;
          3. History of toxic megacolon within 3 months prior to Randomization.&#xD;
&#xD;
          4. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma&#xD;
             within 3 months prior to Screening. Participants with a draining stoma, ostomy, or&#xD;
             extensive colonic resection are excluded irrespective of the time from surgery.&#xD;
&#xD;
          5. Participant has an enterocutaneous or enterovesicular fistula. Participants with other&#xD;
             active fistulas, including perianal fistulas, may be considered for enrollment if&#xD;
             there is no anticipation for surgery and there is no evidence of active infection (eg,&#xD;
             abscess).&#xD;
&#xD;
          6. Bowel perforation during the 6 months prior to Screening or evidence of obstruction&#xD;
             within 3 months of Screening.&#xD;
&#xD;
          7. Complications of CD including short bowel syndrome, strictures/stenoses with&#xD;
             obstruction or pre-stenotic dilation, or conditions where surgery may be anticipated&#xD;
             within 6 months, or other conditions that may confound efficacy evaluations for the&#xD;
             study.&#xD;
&#xD;
          8. Participant has any non-passable colonic stenosis/narrowing identified during the&#xD;
             qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability&#xD;
             to enter the endoscope into the ileum is not covered under this exclusion criterion,&#xD;
             and does not require exclusion).&#xD;
&#xD;
          9. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at&#xD;
             Screening.&#xD;
&#xD;
         10. Participant has any of the following related to infections: • Evidence of a recent&#xD;
             (within 6 months of Randomization) systemic fungal infection, requiring inpatient&#xD;
             hospitalization, and/or antifungal treatment. • Any infection requiring&#xD;
             hospitalization or treatment with IV anti-infectives (including antiviral treatment)&#xD;
             within 4 weeks of Screening. • Cytomegalovirus or Epstein-Barr virus infection that&#xD;
             has not resolved within 8 weeks prior to Screening • Clinically significant chronic&#xD;
             infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening •&#xD;
             Nonserious infection requiring oral anti-infectives within 2 weeks prior to&#xD;
             randomization must be further discussed with the Study Physician/designee. •&#xD;
             Participant has clinical evidence of or suspected to have an abscess during Screening.&#xD;
             • Diagnosis of peritonitis or receiving treatment for peritonitis within 8 weeks prior&#xD;
             to Screening • Participant has any underlying condition that predisposes participant&#xD;
             to infections • Clinically significant active infection or signs/symptoms of infection&#xD;
             that has the potential to worsen with immunosuppressive therapy • Signs or symptoms of&#xD;
             ongoing infection due to intestinal pathogens&#xD;
&#xD;
         11. Previous allogenic bone marrow transplant or history of organ or cell-based&#xD;
             transplantation (eg, islet cell transplantation or autologous stem cell&#xD;
             transplantation) with the exception of corneal transplant.&#xD;
&#xD;
         12. Chronic hepatitis B or C infection.&#xD;
&#xD;
         13. Known history of primary immunodeficiency, splenectomy, or any underlying condition&#xD;
             that predisposes the subject to infection, includingHIV infection.&#xD;
&#xD;
         14. Prior history of or current diagnosis of a demyelinating disorder.&#xD;
&#xD;
         15. Participant has received the following treatment: • Adalimumab, certolizumab pegol,&#xD;
             infliximab, or golimumab: within 8 weeks prior to Randomization • Vedolizumab or&#xD;
             ustekinumab within 12 weeks prior to Randomization • Other prohibited medication,&#xD;
             biologic or small molecule treatment within 5 half-lives prior to Randomization •&#xD;
             Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy&#xD;
&#xD;
         16. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.&#xD;
&#xD;
         17. Participants who received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),&#xD;
             thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening&#xD;
             Visit 1.&#xD;
&#xD;
         18. Known history of allergy to the study intervention formulation or any of its&#xD;
             excipients or components of the delivery device, or to any other biologic therapy.&#xD;
&#xD;
         19. Participants received more than 1 dose of IV or intramuscular steroids within 2 weeks&#xD;
             prior to Screening Visit 1.&#xD;
&#xD;
         20. Participant received topical (rectal) aminosalicylic acid (eg, mesalamine) or topical&#xD;
             (rectal) steroids within 2 weeks prior to Randomization.&#xD;
&#xD;
         21. Participant received a Bacille Calmette-Guérin vaccination within 12 months of&#xD;
             Randomization or any other live vaccine less than 4 weeks prior to Randomization or is&#xD;
             planning to receive any such vaccine over the course of the study.&#xD;
&#xD;
         22. Participant has known or suspected history of chronic use of NSAIDs (defined as at&#xD;
             least 3 times per week for more than 3 months; not applicable to daily aspirin use up&#xD;
             to 325mg per day) and/or opiates, drug, or alcohol abuse.&#xD;
&#xD;
         23. History of cancer with the following exceptions: (a) A history of basal cell carcinoma&#xD;
             and/or squamous cell carcinoma of the skin, with apparent successful curative therapy&#xD;
             greater than 12 months prior to Screening (b) Carcinoma in situ of the cervix, with&#xD;
             apparent successful curative therapy, greater than 12 months prior to Screening.&#xD;
&#xD;
         24. Clinically significant cardiovascular conditions including recent myocardial&#xD;
             infarction, unstable angina, stroke, transient ischemic attack, decompensated heart&#xD;
             failure requiring hospitalization, or Class III/IV heart failure within 6 months of&#xD;
             Screening.&#xD;
&#xD;
         25. Prolonged QTcF interval (QTc &gt;450 msec or QTC &gt;480 for participants with bundle branch&#xD;
             block; determined on central ECG), or conditions leading to additional risk for QT&#xD;
             prolongation (eg, congenital long-QT syndrome).&#xD;
&#xD;
         26. Clinically significant kidney disease&#xD;
&#xD;
         27. Abnormal laboratory results at Screening&#xD;
&#xD;
         28. Other concurrent medical conditions: Participant has known, preexisting, clinically&#xD;
             significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal,&#xD;
             hepatic, hematological, respiratory or any other system abnormalities that are not&#xD;
             associated with CD and are uncontrolled with standard treatment.&#xD;
&#xD;
         29. Participant is currently enrolled in another investigational device or drug study, or&#xD;
             is within 35 days or 5 half-lives, whichever is longer, since ending another&#xD;
             investigational device or drug study, or receiving other investigational agent(s)&#xD;
&#xD;
         30. Transfusion of blood, plasma, or platelets within the 30 days prior to Screening.&#xD;
&#xD;
         31. Females who are pregnant, nursing, or planning a pregnancy during the study OR females&#xD;
             who are of childbearing potential and do not agree to use a highly effective method of&#xD;
             contraception consistently and correctly.&#xD;
&#xD;
         32. Employees of the clinical study site or any other individuals involved with the&#xD;
             conduct of the study, or immediate family members of such individuals.&#xD;
&#xD;
         33. Previous randomization in the present study. . Complete exclusion criteria are in the&#xD;
             study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Bohannon</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>California</state>
        <zip>95648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brownsburg</city>
        <state>Indiana</state>
        <zip>46112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stafford</city>
        <state>Texas</state>
        <zip>77477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 5H6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>370 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Horovice</city>
        <zip>268 31</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 12</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Olomouc</city>
        <zip>772 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10825</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minden</city>
        <zip>32423</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Remscheid</city>
        <zip>42859</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyderabad</city>
        <zip>500032</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jaipur</city>
        <zip>302001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110075</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rajkot</city>
        <zip>360004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Secunderabad</city>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Surat</city>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wardha</city>
        <zip>442004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>HaIFA</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85 168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chojnice</city>
        <zip>89-600</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kraków</city>
        <zip>31-513</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-731</zip>
        <country>Poland</country>
      </address>
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  </location>
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      <address>
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        <zip>35-302</zip>
        <country>Poland</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Sopot</city>
        <zip>81-756</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-635</zip>
        <country>Poland</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-728</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>03-580</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wrocław</city>
        <zip>52-210</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zamość</city>
        <zip>22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aramil</city>
        <zip>624002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>115419</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Perm</city>
        <zip>614000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kosice</city>
        <zip>04013</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nitra</city>
        <zip>94901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7708</zip>
        <country>South Africa</country>
      </address>
    </facility>
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      <name>Research Site</name>
      <address>
        <city>Johannesburg</city>
        <zip>1827</zip>
        <country>South Africa</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Plumstead</city>
        <zip>7800</zip>
        <country>South Africa</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pontevedra</city>
        <zip>36071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>New-Taipei</city>
        <zip>220216</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
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        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
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        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
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      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03680</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04078</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ternopil</city>
        <zip>46001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21028</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Bromwich</city>
        <zip>B71 4HJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>China</country>
    <country>France</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>Inflammatory bowel disease</keyword>
  <keyword>Brazikumab</keyword>
  <keyword>IL23 receptor</keyword>
  <keyword>IBD</keyword>
  <keyword>CD</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>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</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/NCT03759288
org study id: D5271C00001
secondary id: #3150-301-008
secondary id: 2018-004346-42
nct id: NCT03759288
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I)
      and versus an active comparator (Stage 2) in participants with moderately to severely active
      CD and will include assessments of clinical response as demonstrated by improvement of
      symptoms and colonic mucosal appearance as observed on endoscopy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Stage 1. Percentage of patients with CDAI remission
time frame: at Week 12
description: CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 2. Percentage of patients with endoscopic response
time frame: at Week 52
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
measure: Stage 2. Percentage of patients with clinical remission
time frame: at Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).
measure: Stage 1. Percentage of patients with endoscopic response
time frame: at Week 12
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
measure: Stage 1. Percentage of patients with clinical remission
time frame: at Week 12
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).
measure: Stage 1. Percentage of patients with CDAI response
time frame: at Week 12
description: CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 1. Percentage of patients with CDAI remission
time frame: at both Week 12 and Week 52
description: CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 1. Percentage of patients with CDAI response
time frame: at both Week 12 and Week 52
description: CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 1. Percentage of patients with endoscopic response
time frame: at both Week 12 and Week 52
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
measure: Stage 1. Percentage of patients with clinical remission
time frame: at both Week 12 and Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).
measure: Stage 1. Percentage of patients with endoscopic remission
time frame: at Week 52
description: Endoscopic remission is defined as achieving the SES-CD total score of 0-2 OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
measure: Stage 1. Percentage of patients with clinical remission
time frame: at Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire).
measure: Stage 1. Percentage of patients with CDAI response
time frame: at Week 52
description: CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 1. Percentage of patients with CDAI remission
time frame: at Week 52
description: CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
measure: Stage 1. Percentage of patients with endoscopic response
time frame: at Week 52
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
measure: Stage 1. Percentage of patients with SES-CD total score of 0-2
time frame: at Week 52
description: SES-CD total score of 0-2
measure: Stage 1. Percentage of patients with endoscopic response and endoscopic remission
time frame: Endoscopic response at Week 12, endoscopic remission at Week 52
description: Endoscopic response: Minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
measure: Stage 1. Serum concentration of brazikumab
time frame: Through Week 68
description: Pharmacokinetics: concentration of brazikumab in serum
measure: Stage 1. Incidence of anti-drug antibodies
time frame: Through Week 68
description: Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
measure: Stage 1. Exposure-response
time frame: Through Week 68
description: Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
measure: Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2
time frame: at Week 12
description: Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response
measure: Stage 1. Number and percentage of patients with adverse events
time frame: Through Week 68
description: Number and percentage of patients with reported adverse events.
measure: Stage 1. Percentage of patients with potentially clinically significant changes in laboratory values
time frame: Through Week 68
description: Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.
measure: Stage 1. Percentage of patients with potentially clinically significant changes in vital signs
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate.
measure: Stage 1. Percentage of patients with potentially clinically significant changes in physical exams
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in full physical exams.
measure: Stage 1. Percentage of patients with potentially clinically significant changes in ECGs
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
measure: Stage 2. Percentage of patients with endoscopic response
time frame: at both Week 12 and Week 52
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
measure: Stage 2. Percentage of patients with clinical remission
time frame: at both Week 12 and Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)
measure: Stage 2: Percentage of patients with endoscopic remission
time frame: at Week 52
description: Endoscopic remission: - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
measure: Stage 2. Percentage of patients with clinical remission
time frame: at Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)
measure: Stage 2: Percentage of patients with CS-free endoscopic remission
time frame: at Week 52
description: Percentage of patients achieving Endoscopic remission and are CS-free where endoscopic remission is defined as : - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
measure: Stage 2. Percentage of patients with CS-free clinical remission
time frame: at Week 52
description: Percentage of patients achieving CS-free average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item
measure: Stage 2: Percentage of patients with CS-free endoscopic remission
time frame: at Week 52
description: For participants taking CS at Baseline, percentage of patients achieving CS-free endoscopic remission
measure: Stage 2: Percentage of patients with CS-free clinical remission
time frame: at Week 52
description: For participants taking CS at Baseline, percentage of patients achieving CS-free clinical remission
measure: Stage 2. Percentage of patients with endoscopic response
time frame: at Week 12
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
measure: Stage 2. Percentage of patients with clinical remission
time frame: at Week 12
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questrionare)
measure: Stage 2. Percentage of patients with endoscopic response and endoscopic remission
time frame: Endoscopic response at Week 12, endoscopic remission at Week 52
description: Endoscopic response is defined as minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
measure: Stage 2. Percentage of patients with clinical remission
time frame: at both Week 12 and Week 52
description: Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item (measured by PRO questionnaire)
measure: Stage 2. Percentage of patients achieving CS-free endoscopic response
time frame: at Week 52
description: Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
measure: Stage 2. Percentage of patients with clinical remission
time frame: at Week 52
description: Percentage of patients achieving CS-free clinical remission Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item.(measured by PRO questionnaire)
measure: Stage 2. Serum concentration of brazikumab
time frame: Through Week 68
description: Pharmacokinetics: concentration of brazikumab in serum
measure: Stage 2. Incidence of anti-drug antibodies
time frame: Through Week 68
description: Immunogenicity: incidence of brazikumab anti-drug antibodies in blood serum
measure: Stage 2. Exposure-response
time frame: Through Week 68
description: Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
measure: Stage 2. Number and percentage of patients with adverse events
time frame: Through Week 68
description: Number and percentage of patients with reported adverse events
measure: Stage 2. Percentage of patients with potentially clinically significant changes in laboratory values
time frame: Through Week 68
description: Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.
measure: Stage 2. Percentage of patients with potentially clinically significant changes in vital signs
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate
measure: Stage 2. Percentage of patients with potentially clinically significant changes in physical exams
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in full physical exams
measure: Stage 2. Percentage of patients with potentially clinically significant changes in ECGs
time frame: Through Week 68
description: Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
arm group label: (Stage 1) Brazikumab high dose
arm group type: Experimental
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 1) Brazikumab low dose
arm group type: Experimental
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 1) Placebo
arm group type: Placebo Comparator
description: Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 2) Brazikumab high dose
arm group type: Experimental
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 2) Brazikumab low dose
arm group type: Experimental
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 2) Humira®
arm group type: Active Comparator
description: Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
intervention type: Drug
intervention name: Brazikumab low dose
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 1) Brazikumab low dose
arm group label: (Stage 2) Brazikumab low dose
intervention type: Drug
intervention name: Brazikumab high dose
description: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 1) Brazikumab high dose
arm group label: (Stage 2) Brazikumab high dose
intervention type: Drug
intervention name: Humira®
description: Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
arm group label: (Stage 2) Humira®
intervention type: Drug
intervention name: Placebo
description: Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
arm group label: (Stage 1) Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kathy Bohannon
role: Study Director
affiliation: AstraZeneca
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country: Canada
country: Czechia
country: Germany
country: Hungary
country: India
country: Israel
country: Italy
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Slovakia
country: South Africa
country: Spain
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
country: Australia
country: Austria
country: Bulgaria
country: China
country: France
country: Puerto Rico
country: Romania
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Adalimumab
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home