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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: BMS-986165; Other: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Local Institution - 0005
  • Victoria
    • Camberwell, Victoria, Australia, 3142
      • Local Institution - 0002
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6K4B2
      • Local Institution - 0007
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Local Institution - 0025
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Local Institution - 0008
• Germany
  • Berlin, Germany, 12200
    • Local Institution - 0003
  • Dresden, Germany, 01307
    • Local Institution - 0019
  • Kiel, Germany, 24105
    • Local Institution - 0006
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Local Institution - 0009
• Poland
  • Bydgoszcz, Poland, 85-231
    • Local Institution - 0029
  • Bydgoszcz, Poland, 85-794
    • Local Institution - 0028
  • Warsaw, Poland, 00-728
    • Local Institution - 0030
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-798
      • Local Institution - 0031
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Local Institution - 0011
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Local Institution - 0027
  • England
    • London, England, United Kingdom, E11 1NR
      • Local Institution - 0023
• United States
  • California
    • San Diego, California, United States, 92123
      • Local Institution - 0014
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Local Institution - 0036
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Local Institution - 0016
  • New York
    • New York, New York, United States, 10029
      • Local Institution - 0015
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • Local Institution - 0026
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 0013
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Local Institution - 0020
  • Texas
    • Garland, Texas, United States, 75044
      • Local Institution - 0032
    • Lubbock, Texas, United States, 74910
      • Local Institution - 0039
    • Southlake, Texas, United States, 76092
      • Local Institution - 0033

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo Comparator; Specified Dose on Specified Days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants in clinical response	At Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AEs)	Baseline to Week 56

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-127; 2019-004878-26 (EudraCT Number); U1111-1245-2970 (Other Identifier: World Health Organization)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No