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A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

NCT04613518•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
•Moderately to severely active UC as assessed by the modified Mayo score
•Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors\[SA1\]
•Documentation of prior treatment with corticosteroids for ≥ 4 weeks
•Males and females must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

•Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
•Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
•History or evidence of any extensive colonic resection, or subtotal or total colectomy
•Women who are pregnant or breastfeeding
•Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor

Locations (26)

Local Institution - 0014

San Diego, California, United States

Local Institution - 0036

Arlington Heights, Illinois, United States

Local Institution - 0016

Shreveport, Louisiana, United States

Local Institution - 0015

New York, New York, United States

Local Institution - 0026

Chapel Hill, North Carolina, United States

Local Institution - 0013

Cleveland, Ohio, United States

Local Institution - 0020

Oklahoma City, Oklahoma, United States

Local Institution - 0032

Garland, Texas, United States

Local Institution - 0039

Lubbock, Texas, United States

Local Institution - 0033

Southlake, Texas, United States

Key Dates

Start Date

March 15, 2021

Primary Completion Date

May 31, 2023

Completion Date

November 29, 2023

Last Updated

July 12, 2024

Enrollment

ACTUAL participants

Conditions

Colitis, Ulcerative

Interventions

BMS-986165

DRUG

Placebo Comparator

OTHER

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

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RECRUITINGPHASE3

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

NCT06651281

Crohn DiseaseColitis, Ulcerative

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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 12, 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

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Diet Intervention Treatment for Active Ulcerative Colitis

Therapeutic Endpoint in Pediatric IBD Conditions

Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis