For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution
  2. Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments
  3. Must have active moderate to severe CD
  4. Men and women must agree to follow specific methods of contraception, if applicable

EXCLUSION CRITERIA

  1. Severe or fulminant colitis that is likely to require surgery or hospitalization
  2. Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease
  3. Previous exposure to BMS-986165 in any study
  4. 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
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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.
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Study’s details


Contition

Crohn's Disease,Crohn's Enteritis,Granulomatous Colitis,Granulomatous Enteritis

Age (in years)

18 - 75

Phase

Phase 2

Participants needed

241

Est. Completion Date

Sep 2024

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT03599622

Study number

IM011023

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