A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Study Identifier
M13-740
CT.gov Identifier
NCT02365649
EudraCT Identifier
2014-003240-12
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
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Statistical Analysis Plan
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Scientific Result Summary
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • Placebo
  • ABT-494
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Diagnosis of Crohn's disease (CD) for at least 90 days. 2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450. 3. Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
    Exclusion Criteria:
    1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis. 2. Subject who has had surgical bowel resections in the past 6 months or is planning resection. 3. Subjects with an ostomy or ileoanal pouch. 4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess. 5. Subject who has short bowel syndrome. 6. Subject with recurring infections or active Tuberculosis (TB).

    Protocol Summary

    To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

    Study Locations

    No locations found.