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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04613518
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : June 22, 2022
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Colitis, Ulcerative Drug: BMS-986165 Other: Placebo Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
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 15, 2021
Estimated Primary Completion Date : February 22, 2023
Estimated Study Completion Date : December 27, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BMS-986165 Drug: BMS-986165
Specified Dose on Specified Days

Placebo Comparator: Placebo Other: Placebo Comparator
Specified Dose on Specified Days

Experimental: Open label Extension, BMS-986165 Drug: BMS-986165
Specified Dose on Specified Days

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04613518

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Contact: BMS Study Connect Contact Center 855-907-3286
Contact: First line of the email MUST contain NCT # and Site #.

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT04613518    
Other Study ID Numbers: IM011-127
2019-004878-26 ( EudraCT Number )
U1111-1245-2970 ( Other Identifier: World Health Organization )
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action