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: Completed
• 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, 1081 HZ
      • Local Institution - 0009
• Poland
  • Bydgoszcz, Poland, 85-231
    • Local Institution - 0029
  • Bydgoszcz, Poland, 85-794
    • Local Institution - 0028
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-798
      • Local Institution - 0031
    • Warszawa, Mazowieckie, Poland, 04-501
      • Local Institution - 0030
• 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	Measure Description	Time Frame
Percentage of Participants in Clinical Response at Week 12	Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment); A decrease from baseline in the modified Mayo score of ≥ 2 points, and; A decrease from baseline in the modified Mayo score ≥ 30%, and; A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: Stool frequency (SF) subscore (0 to 3); Rectal bleeding (RB) subscore (0 to 3); Endoscopic (ES) subscore (0 to 3)	At week 12
Number of Participants Experiencing Adverse Events (AEs)	An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.	From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.	From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.	From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
Number of Participants Experiencing Adverse Events of Special Interest (AEIs)	An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.	From first dose to 52 weeks after first dose

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
• FDA Safety Alerts and Recalls

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): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 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