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

Primary Purpose

Colitis, Ulcerative

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo Comparator
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution - 0014
  • Local Institution - 0036
  • Local Institution - 0016
  • Local Institution - 0015
  • Local Institution - 0026
  • Local Institution - 0013
  • Local Institution - 0020
  • Local Institution - 0032
  • Local Institution - 0039
  • Local Institution - 0033
  • Local Institution - 0005
  • Local Institution - 0002
  • Local Institution - 0007
  • Local Institution - 0025
  • Local Institution - 0008
  • Local Institution - 0003
  • Local Institution - 0019
  • Local Institution - 0006
  • Local Institution - 0009
  • Local Institution - 0031
  • Local Institution - 0029
  • Local Institution - 0028
  • Local Institution - 0030
  • Local Institution - 0011
  • Local Institution - 0023
  • Local Institution - 0027

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

BMS-986165

Placebo

Open label Extension, BMS-986165

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants in clinical response

Secondary Outcome Measures

Number of adverse events (AEs)

Full Information

First Posted
October 28, 2020
Last Updated
September 26, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04613518
Brief Title
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Open label Extension, BMS-986165
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified Dose on Specified Days
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Proportion of participants in clinical response
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Number of adverse events (AEs)
Time Frame
Baseline to Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0014
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution - 0036
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Local Institution - 0016
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Local Institution - 0015
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 0026
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Local Institution - 0013
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 0020
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Local Institution - 0032
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Local Institution - 0039
City
Lubbock
State/Province
Texas
ZIP/Postal Code
74910
Country
United States
Facility Name
Local Institution - 0033
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Local Institution - 0005
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution - 0002
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3142
Country
Australia
Facility Name
Local Institution - 0007
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K4B2
Country
Canada
Facility Name
Local Institution - 0025
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Local Institution - 0008
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Local Institution - 0003
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Local Institution - 0019
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 0006
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 0009
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Local Institution - 0031
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-798
Country
Poland
Facility Name
Local Institution - 0029
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Local Institution - 0028
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
Local Institution - 0030
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Local Institution - 0011
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Local Institution - 0023
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Local Institution - 0027
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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