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

  • Clinicaltrials.gov identifier

    NCT04613518

  • Recruitment Status

    Recruiting

  • First Posted

    November 3, 2020

  • Last update posted

    April 22, 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

N/A

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

Criteria

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

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations

United States, California
Medical Associates Research Group
San Diego

United States, Louisiana
Louisiana Research Center-Research
Shreveport

United States, New York
Local Institution
New York

United States, North Carolina
Local Institution
Chapel Hill

United States, Ohio
Cleveland Clinic-Gastroenterology
Cleveland

United States, Oklahoma
Digestive Disease Specialists
Oklahoma City

United States, Texas
Local Institution
Garland

United States, Texas
Local Institution
Southlake

Australia, New South Wales
St Vincent's Hospital-Gastroenterology
Darlinghurst

Australia, Victoria
Local Institution - 0002
Camberwell

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution
London

Canada, Ontario
Local Institution - 0008
Vaughan

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

Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medizinische Klinik I, Hepatology
Dresden

Germany
Local Institution - 0006
Kiel

Netherlands
Local Institution - 0009
Amsterdam

Poland
Local Institution - 0029
Bydgoszcz

Poland
Local Institution - 0028
Bydgoszcz

Poland
Local Institution - 0030
Warsaw

Poland
Local Institution
Warszawa

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

United Kingdom
Local Institution
Cambridge

United Kingdom
Local Institution
London

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov 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: April 22, 2022
  • Last Verified: April 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
    Ulcer
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Colonic Diseases
    Intestinal Diseases
    Pathologic Processes
    Inflammatory Bowel Diseases