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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Granulomatous Colitis, Crohn's Disease, Crohn's Enteritis, Granulomatous Enteritis

In brief

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.

Key facts

Study ID

NCT03599622

Run by

Bristol-Myers Squibb

People needed

239

Starts

2018-07-16

Expected to finish

2023-10-23

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0247 — Aurora, Colorado, United States
• Local Institution - 0001 — Hamden, Connecticut, United States
• Local Institution - 0255 — Clearwater, Florida, United States
• Local Institution - 0259 — Jacksonville, Florida, United States
• Local Institution - 0261 — Jacksonville, Florida, United States
• Local Institution - 0276 — Largo, Florida, United States
• Local Institution - 0232 — Miami, Florida, United States
• Local Institution - 0162 — New Port Richey, Florida, United States
• Local Institution - 0201 — Orlando, Florida, United States
• Local Institution - 0249 — Orlando, Florida, United States
• Local Institution - 0166 — Tampa, Florida, United States
• Local Institution - 0248 — Zephyrhills, Florida, United States
• Local Institution - 0277 — Suwanee, Georgia, United States
• Local Institution - 0358 — Suwanee, Georgia, United States
• Local Institution - 0319 — Chicago, Illinois, United States
• Local Institution - 0346 — Glenview, Illinois, United States
• Local Institution - 0301 — Indianapolis, Indiana, United States
• Local Institution - 0253 — Iowa City, Iowa, United States
• Local Institution - 0282 — Shreveport, Louisiana, United States
• Local Institution - 0003 — Chesterfield, Michigan, United States
• Local Institution - 0218 — Chesterfield, Michigan, United States
• Local Institution - 0047 — Wyoming, Michigan, United States
• Local Institution - 0223 — Ypsilanti, Michigan, United States
• Local Institution - 0231 — Jackson, Mississippi, United States
• Local Institution - 0258 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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