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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

    July 13, 2021

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

  • Condition or Disease:Colitis, Ulcerative
  • Intervention/Treatment: Drug: BMS-986165 Dose 1
    Drug: BMS-986165 Dose 2
    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 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
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: April 2023

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1
Drug: BMS-986165 Dose 1
Specified Dose on Specified Days
Experimental: BMS-986165 Dose 2
Drug: BMS-986165 Dose 2
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 ]
  • Other 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


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit Inclusion Criteria: - Confirmed diagnosis of 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 - 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, 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 TYK2 inhibitor Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations


Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

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


United States, California
Local Institution
San Diego

United States, Louisiana
Local Institution

United States, New York
Local Institution
New York

United States, North Carolina
Local Institution
Chapel Hill

United States, Ohio
Cleveland Clinic-Gastroenterology

United States, Oklahoma
Local Institution
Oklahoma City

Australia, New South Wales
Local Institution

Australia, Victoria
Emeritus Research

Canada, Alberta
Local Institution

Canada, Ontario
Local Institution

Canada, Ontario
Local Institution

Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroentero

Universitaetsklinikum Carl Gustav Carus Dresden-Medizinische Klinik I, Hepatology

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Allgemeine Innere Medizin I

Academisch Medisch Centrum-Inflammatory Bowel Disease

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

United Kingdom
Local Institution

United Kingdom
Local Institution

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: July 13, 2021
  • Last Verified: July 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Ulcer
    Colitis, Ulcerative