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An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT03599622•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (259)

Local Institution - 0258

Los Angeles, California, United States

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

Key Dates

Start Date

July 16, 2018

Primary Completion Date

December 12, 2022

Completion Date

October 23, 2023

Last Updated

July 3, 2024

Enrollment

239

ACTUAL participants

Conditions

Granulomatous ColitisCrohn's DiseaseCrohn's EnteritisGranulomatous Enteritis

Interventions

BMS-986165

DRUG

Placebo

OTHER

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease