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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

    July 13, 2021

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

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

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 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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

United States, California
Local Institution
San Diego

United States, Louisiana
Local Institution
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
Local Institution
Oklahoma City

Australia, New South Wales
Local Institution
Darlinghurst

Australia, Victoria
Emeritus Research
Camberwell

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution
London

Canada, Ontario
Local Institution
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
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Allgemeine Innere Medizin I
Kiel

Netherlands
Academisch Medisch Centrum-Inflammatory Bowel Disease
Amsterdam

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: 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     Colitis