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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

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

Intervention / Treatment
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* Drug: BMS-986165
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 Dose 1<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>|
| Experimental: BMS-986165 Dose 2<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving clinical remission at Week 12 | Clinical remission defined by Crohn's Disease Activity Index (CDAI) | Week 12 | 
| Proportion of participants achieving endoscopic response at Week 12 | Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve a clinical response at Week 12 |  | Week 12 | 
| Proportion of participants who achieve PRO2 [Participant reported outcome based on the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI)] remission at Week 12 |  | Week 12 | 
| Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12 |  | Week 12 |