Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: BMS-986263; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04267393

2019-003932-22 (EudraCT Number)

U1111-1241-4762 (Other Identifier)

IM025-017

Details and patient eligibility

About

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

Enrollment: 124 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months
• Men and women must agree to follow methods of contraception

Exclusion criteria

• 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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 3 patient groups, including a placebo group

Dose A BMS-986263

Experimental group

Treatment:

Drug: BMS-986263

Dose B BMS-986263

Experimental group

Treatment:

Drug: BMS-986263

Placebo

Placebo Comparator group

Treatment:

Other: Placebo