An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

• Status: Recruiting
• Trial end date: 2024-03-12
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

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