A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

ASC42-202

This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.

2022-04-06

2024-03-13

2024-03-13

Completed

Early phase I

98

Inclusion Criteria: * Age ≥ 18 and ≤75 years old at screening. * Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: 1. Biochemical evidence of cholestasis based on ALP elevation. 2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative. 3. Liver biopsy consistent with PBC. * Screening ALP ≥ 1.67× ULN * Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0. Exclusion Criteria: * ALT or AST \> 5× ULN; ALP \>10× ULN * History or presence of other concomitant liver diseases * Child-Pugh grade B or C

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}

2024-04-04