An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Granulomatous Colitis,Crohn's Disease,Crohn's Enteritis,Granulomatous Enteritis
Age (in years)
18 - 75
Phase
Phase 2
Participants needed
241
Est. Completion Date
Sep 25, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT03599622
Study number
IM011023
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?