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

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

Local Institution, New York, New York

Status

Not yet recruiting

Address

Local Institution

New York, New York, 10029

Site Contact

Site 0015

Clinical.Trials@bms.com

855-907-3286

Local Institution, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

Local Institution

Chapel Hill, North Carolina, 27599-7080

Site Contact

Site 0026

Clinical.Trials@bms.com

855-907-3286

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

Local Institution, Garland, Texas

Status

Not yet recruiting

Address

Local Institution

Garland, Texas, 75044

Site Contact

Site 0032

Clinical.Trials@bms.com

855-907-3286

Local Institution, Southlake, Texas

Status

Not yet recruiting

Address

Local Institution

Southlake, Texas, 76092

Site Contact

Site 0033

Clinical.Trials@bms.com

855-907-3286

International Sites

St Vincent's Hospital-Gastroenterology, Darlinghurst, New South Wales, Australia

Status

Recruiting

Address

St Vincent's Hospital-Gastroenterology

Darlinghurst, New South Wales, 2010

Site Contact

Simon Ghaly, Site 0005

Clinical.Trials@bms.com

+61283824984

Local Institution - 0002, Camberwell, Victoria, Australia

Status

Recruiting

Address

Local Institution - 0002

Camberwell, Victoria, 3142

Site Contact

Site 0002

Clinical.Trials@bms.com

855-907-3286

Local Institution, Edmonton, Alberta, Canada

Status

Recruiting

Address

Local Institution

Edmonton, Alberta, T6K 4B2

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

Berlin, Germany

Status

Recruiting

Address

Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroentero

Berlin, , 12200

Site Contact

Britta Siegmund, Site 0003

Clinical.Trials@bms.com

+49030450514342

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus Dresden-Medizinische Klinik I, Hepatology

Dresden, , 01307

Site Contact

Sebastian Zeissig, Site 0019

Clinical.Trials@bms.com

+4935145819719

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, Warszawa, Poland

Status

Not yet recruiting

Address

Local Institution

Warszawa, , 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, , 00935-5067

Site Contact

Esther Torres Rodriguez, Site 0011

Clinical.Trials@bms.com

7877540101x3192

Local Institution, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Local Institution

Cambridge, , CB2 0QQ

Site Contact

Site 0027

Clinical.Trials@bms.com

855-907-3286

Local Institution, London, United Kingdom

Status

Not yet recruiting

Address

Local Institution

London, , E11 1NR

Site Contact

Site 0023

Clinical.Trials@bms.com

855-907-3286

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.