Safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (liver disease) from nonalcoholic steatohepatitis (NASH).
- Conditions
- Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)MedDRA version: 20.1Level: LLTClassification code 10064844Term: Compensated cirrhosisSystem Organ Class: 100000004871MedDRA version: 20.0Level: HLTClassification code 10019669Term: Hepatic fibrosis and cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-003932-22-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 270
- Participants with liver biopsy fibrosis score stage 4 performed within 6 months
- Men and women must agree to follow methods of contraception
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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81
- Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator;
- Known immunocompromised status or any disease or condition which might compromise participant safety;
- Prior exposure to BMS-986263
- Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests;
- Hepatic decompensation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: _To evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASH;Secondary Objective: _To further assess the efficacy of BMS-986263 compared with placebo to improve liver fibrosis, as determined by liver biopsy, in participants with compensated cirrhosis due to NASH;<br>_To assess the safety and tolerability of BMS-986263 in participants with compensated cirrhosis due to NASH;<br>_To assess the PK of BMS-986263 in participants with compensated cirrhosis due to NASH;Primary end point(s): Proportion of participants who achieve = 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment;;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method