NCT02365649
Brief summary
To determine the efficacy and safety of multiple doses of an active drug 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.
Interventional study
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Age:
From 18 Years to 75 Years.
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 experience 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).
