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

  • identifier


  • Recruitment Status


  • First Posted

    November 3, 2020

  • Last update posted

    September 23, 2022

Study Description

Brief 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.

  • Condition or Disease:Colitis, Ulcerative
  • Intervention/Treatment: Drug: BMS-986165
    Other: Placebo Comparator
  • Phase: Phase 2

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165
Drug: BMS-986165
Specified Dose on Specified Days
Experimental: Open label Extension, BMS-986165
Drug: BMS-986165
Specified Dose on Specified Days
Placebo Comparator: Placebo
Other: Placebo Comparator
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants in clinical response [ Time Frame: At Week 12 ]
  • Secondary Outcome Measures: 1. Number of adverse events (AEs) [ Time Frame: Baseline to Week 56 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


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 Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations


Contact: BMS Study Connect Contact Center 855-907-3286

Contact: First line of the email MUST contain NCT # and Site #.


United States, California
Medical Associates Research Group
San Diego

United States, Illinois
Illinois Gastroenterology Group - Arlington Heights
Arlington Heights

United States, Louisiana
Louisiana Research Center-Research

United States, New York
Icahn School Of Medicine At Mount Sinai
New York

United States, North Carolina
Clinical & Translational Research Center (CTRC)
Chapel Hill

United States, Ohio
Cleveland Clinic-Gastroenterology

United States, Oklahoma
Digestive Disease Specialists
Oklahoma City

United States, Texas
DHAT Research Institute

United States, Texas
Lubbock Digestive Disease Associates

United States, Texas
GI Alliance

Australia, New South Wales
Local Institution - 0005

Australia, Victoria
Local Institution - 0002

Canada, Alberta
Local Institution - 0007

Canada, Ontario
Local Institution - 0025

Canada, Ontario
Local Institution - 0008

Local Institution - 0003

Local Institution - 0019

Local Institution - 0006

Local Institution - 0009

Local Institution - 0029

Local Institution - 0028

Local Institution - 0030

Local Institution - 0031

Puerto Rico
UPR Medical Sciences Campus-UPR GI Research Unit
San Juan

United Kingdom, England
Local Institution - 0023

United Kingdom
Local Institution - 0027

Sponsors and Collaborators

Bristol-Myers Squibb


Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • Identifier: NCT04613518 History of Changes
  • Other Study ID Numbers: IM011-127, 2019-004878-26, U1111-1245-2970
  • First Posted: November 3, 2020 Key Record Dates
  • Last Update Posted: September 23, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Gastrointestinal Diseases
    Digestive System Diseases
    Colonic Diseases
    Intestinal Diseases
    Pathologic Processes
    Inflammatory Bowel Diseases