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Trial ID IM011-023  |   NCT03599622

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18-75
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 Eligibility 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: - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: BMS-986165 Dose 1

ASSIGNED INTERVENTION
  • Drug: BMS-986165

Study Arms

Experimental: BMS-986165 Dose 2

ASSIGNED INTERVENTION
  • Drug: BMS-986165

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION
  • Other: Placebo

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com