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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04613518
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Germany, Netherlands, Poland, Puerto Rico, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: BMS-986165

Placebo Comparator: Placebo

Experimental: Open label Extension, BMS-986165

Interventions

Drug: - BMS-986165

Specified Dose on Specified Days

Other: - Placebo Comparator

Specified Dose on Specified Days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical Associates Research Group, San Diego, California

Status

Recruiting

Address

Medical Associates Research Group

San Diego, California, 92123

Site Contact

Hyun Kim, Site 0014

Clinical.Trials@bms.com

85827778225

Arlington Heights, Illinois

Status

Not yet recruiting

Address

Illinois Gastroenterology Group - Arlington Heights

Arlington Heights, Illinois, 60005

Site Contact

Mitchell Bernsen, Site 0036

Clinical.Trials@bms.com

847-439-1005

Louisiana Research Center-Research, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center-Research

Shreveport, Louisiana, 71105

Site Contact

Humberto Aguilar, Site 0016

Clinical.Trials@bms.com

318-423-9196

Icahn School Of Medicine At Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School Of Medicine At Mount Sinai

New York, New York, 10029

Site Contact

Jean-Frederic Colombel, Site 0015

Clinical.Trials@bms.com

347-276-8330

Chapel Hill, North Carolina

Status

Recruiting

Address

Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599-7080

Site Contact

Hans Herfarth, Site 0026

Clinical.Trials@bms.com

919-966-6806

Cleveland Clinic-Gastroenterology, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic-Gastroenterology

Cleveland, Ohio, 44195

Site Contact

Benjamin Cohen, Site 0013

Clinical.Trials@bms.com

216-337-5899

Digestive Disease Specialists, Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists

Oklahoma City, Oklahoma, 73112

Site Contact

Sumit Walia, Site 0020

Clinical.Trials@bms.com

405-702-1246

DHAT Research Institute, Garland, Texas

Status

Recruiting

Address

DHAT Research Institute

Garland, Texas, 75044

Site Contact

Harry Sarles, Site 0032

Clinical.Trials@bms.com

214-274-5464

Lubbock Digestive Disease Associates, Lubbock, Texas

Status

Not yet recruiting

Address

Lubbock Digestive Disease Associates

Lubbock, Texas, 74910

Site Contact

Cari Sorrell, Site 0039

Clinical.Trials@bms.com

806-793-3141

GI Alliance, Southlake, Texas

Status

Recruiting

Address

GI Alliance

Southlake, Texas, 76092

Site Contact

Timothy Ritter, Site 0033

Clinical.Trials@bms.com

817-424-1525

International Sites

Local Institution - 0005, Sydney, New South Wales, Australia

Status

Recruiting

Address

Local Institution - 0005

Sydney, New South Wales, 2010

Site Contact

Site 0005

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0002, Camberwell, Victoria, Australia

Status

Completed

Address

Local Institution - 0002

Camberwell, Victoria, 3142

Local Institution - 0007, Edmonton, Alberta, Canada

Status

Recruiting

Address

Local Institution - 0007

Edmonton, Alberta, T6K4B2

Site Contact

Site 0007

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0025, London, Ontario, Canada

Status

Recruiting

Address

Local Institution - 0025

London, Ontario, N6A 5A5

Site Contact

Site 0025

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0008, Vaughan, Ontario, Canada

Status

Recruiting

Address

Local Institution - 0008

Vaughan, Ontario, L4L 4Y7

Site Contact

Site 0008

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0003, Berlin, Germany

Status

Recruiting

Address

Local Institution - 0003

Berlin, , 12200

Site Contact

Site 0003

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0019, Dresden, Germany

Status

Recruiting

Address

Local Institution - 0019

Dresden, , 01307

Site Contact

Site 0019

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0006, Kiel, Germany

Status

Recruiting

Address

Local Institution - 0006

Kiel, , 24105

Site Contact

Site 0006

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0009, Amsterdam, Netherlands

Status

Recruiting

Address

Local Institution - 0009

Amsterdam, , 1105 AZ

Site Contact

Site 0009

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0029, Bydgoszcz, Poland

Status

Recruiting

Address

Local Institution - 0029

Bydgoszcz, , 85-231

Site Contact

Site 0029

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0028, Bydgoszcz, Poland

Status

Recruiting

Address

Local Institution - 0028

Bydgoszcz, , 85-794

Site Contact

Site 0028

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0030, Warsaw, Poland

Status

Recruiting

Address

Local Institution - 0030

Warsaw, , 00-728

Site Contact

Site 0030

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0031, Warsaw, Poland

Status

Recruiting

Address

Local Institution - 0031

Warsaw, , 02-798

Site Contact

Site 0031

Clinical.Trials@bms.com

855-907-3286

San Juan, Puerto Rico

Status

Recruiting

Address

UPR Medical Sciences Campus-UPR GI Research Unit

San Juan, , 00935

Site Contact

Esther Torres Rodriguez, Site 0011

Clinical.Trials@bms.com

7877518011

Local Institution - 0023, London, England, United Kingdom

Status

Recruiting

Address

Local Institution - 0023

London, England, E11 1NR

Site Contact

Site 0023

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0027, Cambridge, United Kingdom

Status

Recruiting

Address

Local Institution - 0027

Cambridge, , CB2 0QQ

Site Contact

Site 0027

Clinical.Trials@bms.com

855-907-3286

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