Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04613518
Collaborator
(none)
50
Enrollment
24
Locations
3
Arms
33.4
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 15, 2021
Anticipated Primary Completion Date :
Feb 22, 2023
Anticipated Study Completion Date :
Dec 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986165

Drug: BMS-986165
Specified Dose on Specified Days
Placebo Comparator: Placebo

Other: Placebo Comparator
Specified Dose on Specified Days
Experimental: Open label Extension, BMS-986165

Drug: BMS-986165
Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants in clinical response [At Week 12]

Secondary Outcome Measures

  1. Number of adverse events (AEs) [Baseline to Week 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Medical Associates Research Group San Diego California United States 92123
2 Louisiana Research Center-Research Shreveport Louisiana United States 71105
3 Local Institution New York New York United States 10029
4 Clinical & Translational Research Center (CTRC) Chapel Hill North Carolina United States 27599-7080
5 Cleveland Clinic-Gastroenterology Cleveland Ohio United States 44195
6 Digestive Disease Specialists Oklahoma City Oklahoma United States 73112
7 Local Institution Garland Texas United States 75044
8 Local Institution Southlake Texas United States 76092
9 Local Institution - 0005 Sydney New South Wales Australia 2010
10 Local Institution - 0002 Camberwell Victoria Australia 3142
11 Local Institution - 0007 Edmonton Alberta Canada T6K4B2
12 Local Institution - 0025 London Ontario Canada N6A 5A5
13 Local Institution - 0008 Vaughan Ontario Canada L4L 4Y7
14 Local Institution - 0003 Berlin Germany 12200
15 Local Institution - 0019 Dresden Germany 01307
16 Local Institution - 0006 Kiel Germany 24105
17 Local Institution - 0009 Amsterdam Netherlands 1105 AZ
18 Local Institution - 0029 Bydgoszcz Poland 85-231
19 Local Institution - 0028 Bydgoszcz Poland 85-794
20 Local Institution - 0030 Warsaw Poland 00-728
21 Local Institution - 0031 Warsaw Poland 02-798
22 UPR Medical Sciences Campus-UPR GI Research Unit San Juan Puerto Rico 00935
23 Local Institution - 0023 London England United Kingdom E11 1NR
24 Local Institution Cambridge United Kingdom CB2 0QQ

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04613518
Other Study ID Numbers:
  • IM011-127
  • 2019-004878-26
  • U1111-1245-2970
First Posted:
Nov 3, 2020
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 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
BMS-986165

Study Results

No Results Posted as of Aug 1, 2022