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

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • - Confirmed diagnosis of 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.
  • - 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, 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 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, Puerto Rico, 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 Dose 1

Experimental: BMS-986165 Dose 2

Placebo Comparator: Placebo

Interventions

Drug: - BMS-986165 Dose 1

Specified Dose on Specified Days

Drug: - BMS-986165 Dose 2

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.

Local Institution, San Diego, California

Status

Not yet recruiting

Address

Local Institution

San Diego, California, 92123

Site Contact

Site 0014

Clinical.Trials@bms.com

please email:

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

please email:

Local Institution, Cleveland, Ohio

Status

Not yet recruiting

Address

Local Institution

Cleveland, Ohio, 44195

Site Contact

Site 0013

Clinical.Trials@bms.com

please email:

International Sites

Local Institution, Darlinghurst, New South Wales, Australia

Status

Not yet recruiting

Address

Local Institution

Darlinghurst, New South Wales, 2010

Site Contact

Site 0005

Clinical.Trials@bms.com

please email:

Emeritus Research, Camberwell, Victoria, Australia

Status

Recruiting

Address

Emeritus Research

Camberwell, Victoria, 3142

Site Contact

Edward Shelton, Site 0002

Clinical.Trials@bms.com

+61395096166

Local Institution, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

Local Institution

Edmonton, Alberta, T6L 6K3

Site Contact

Site 0007

Clinical.Trials@bms.com

please email:

Local Institution, Vaughan, Ontario, Canada

Status

Not yet recruiting

Address

Local Institution

Vaughan, Ontario, L4L 4Y7

Site Contact

Site 0001

Clinical.Trials@bms.com

please email:

Local Institution, Vaughan, Ontario, Canada

Status

Not yet recruiting

Address

Local Institution

Vaughan, Ontario, L4L 4Y7

Site Contact

Site 0008

Clinical.Trials@bms.com

please email:

Local Institution, Berlin, Germany

Status

Not yet recruiting

Address

Local Institution

Berlin, , 12200

Site Contact

Site 0003

Clinical.Trials@bms.com

please email:

Local Institution, Kiel, Germany

Status

Not yet recruiting

Address

Local Institution

Kiel, , 24105

Site Contact

Site 0006

Clinical.Trials@bms.com

please email:

Local Institution, Amsterdam, Netherlands

Status

Not yet recruiting

Address

Local Institution

Amsterdam, , 1105 AZ

Site Contact

Site 0009

Clinical.Trials@bms.com

please email:

Local Institution, San Juan, Puerto Rico

Status

Not yet recruiting

Address

Local Institution

San Juan, , 00935-5067

Site Contact

Site 0011

Clinical.Trials@bms.com

please email:

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