Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Phase 2

Completed

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: ASC42 15 mg; Drug: Placebo; Drug: ASC42 5 mg; Drug: ASC42 10 mg

• Registration Number: NCT05190523
• Lead Sponsor: Gannex Pharma Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-04-06
• Primary Completion: 2024-03-13
• Study Completion: 2024-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC42 tablets of 15mg	ASC42 15 mg	ASC42 tablets 15mg for 12 weeks
Placebo	Placebo	Placebo for 12 weeks
ASC42 tablets of 5mg	ASC42 5 mg	ASC42 tablets 5mg for 12 weeks
ASC42 tablets of 10mg	ASC42 10 mg	ASC42 tablets 10mg for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage changes of alkaline phosphatase (ALP) compared with baseline.	Day85

Secondary Outcome Measures

Name	Time	Method
Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.	Day15\29\57\85
Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.	Day15\29\57\85
Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.	Day15\29\57\85

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China