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

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004878-26-NL

Enrollment

100

Registered

2020-10-20

Start date

2021-02-10

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: BMS-986165 Product Code: BMS-986165 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TYK2 Inhibitor CAS Number: 1609392-28-0 Current Sponsor code: BMS-986165 Other descriptiv

Eligibility

Sex/Gender

All

Inclusion criteria

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 - Documentation of prior treatment with corticosteroids for = 4 weeks - Males and females must agree to follow specific methods of contraception, if applicable Other protocol-defined inclusion criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 93 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

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 exclusion criteria apply.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): There is no secondary endpoint in this trial. Other pre-specified study endpoint: - Number of Adverse Events (AEs). ;Timepoint(s) of evaluation of this end point: - From Baseline to week 56	—

Primary

Measure	Time frame
Main Objective: -To estimate the efficacy of BMS-986165 at Week 12 ;Secondary Objective: -To assess the safety and tolerability of BMS-986165;Primary end point(s): - Proportion of participants in clinical response;Timepoint(s) of evaluation of this end point: - At week 12.	—

Countries

Australia, Canada, Germany, Netherlands, Poland, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026