Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to
placebo in participants with moderately to severely active Crohn's Disease.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Gastrointestinal, Stomach, Esophageal
Enrollment Eligibility
Inclusion Criteria:
- Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening,
including ileal, colonic, or ileo-colonic disease distribution
- Must have had an inadequate response, loss of response, or intolerance to 1 or more of
the standard treatments
- Must have active moderate to severe CD
- Men and women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Severe or fulminant colitis that is likely to require surgery or hospitalization
- Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory
including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than
Crohn's Disease
- Previous exposure to BMS-986165 in any study
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal,
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic,
psychiatric, or local active infection/infectious illness) that, in the investigator's
judgment, will substantially increase the risk to the participant
Other protocol-defined inclusion/exclusion criteria apply