A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis
- Conditions
- Moderate to Severe Ulcerative Colitis.MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-004878-26-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -To estimate the efficacy of BMS-986165 at Week 12<br>;Secondary Objective: There is no Secondary Objective in this trial. <br>Other pre-specified study objective:<br>- 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There is no secondary endpoint in this trial. <br>Other pre-specified study endpoint: <br>- Number of Adverse Events (AEs). ;Timepoint(s) of evaluation of this end point: - From Baseline to week 56