Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 65 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Bristol-Myers Squibb|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Canada, Germany, Netherlands, Poland, Puerto Rico, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Placebo Comparator: Placebo
Experimental: Open label Extension, BMS-986165
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.