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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 2

Conditions

Granulomatous Enteritis

Crohn's Disease

Granulomatous Colitis

Crohn's Enteritis

Treatments

Drug: BMS-986165

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03599622

IM011-023

2017-001976-48 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

239 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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