An Investigational Study of Experimental Medication BMS-986165 in Patients With Moderate to Severe Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- JPRN-jRCT2080224183
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
Documented diagnosis of Crohn's Disease (CD) of at least 3 months' duration, including ileal, colonic, or ileo-colonic disease distribution
Must have active moderate to severe CD
Men and women must agree to follow specific methods of contraception, if applicable
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method