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

Gannex Pharma Co., Ltd.1 site in 1 country98 target enrollmentApril 6, 2022

ConditionsPrimary Biliary Cholangitis

InterventionsASC42 5 mg ASC42 10 mg ASC42 15 mg Placebo

DrugsASC42 5 mg ASC42 10 mg ASC42 15 mg Placebo

Overview

Phase: Phase 2
Intervention: ASC42 5 mg
Conditions: Primary Biliary Cholangitis
Sponsor: Gannex Pharma Co., Ltd.
Enrollment: 98
Locations: 1
Primary Endpoint: Percentage changes of alkaline phosphatase (ALP) compared with baseline.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 6, 2022

End Date

March 13, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gannex Pharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•Biochemical evidence of cholestasis based on ALP elevation.
•Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
•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

Arms & Interventions

ASC42 tablets of 5mg

ASC42 tablets 5mg for 12 weeks

Intervention: ASC42 5 mg

ASC42 tablets of 10mg

ASC42 tablets 10mg for 12 weeks

Intervention: ASC42 10 mg

ASC42 tablets of 15mg

ASC42 tablets 15mg for 12 weeks

Intervention: ASC42 15 mg

Placebo

Placebo for 12 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage changes of alkaline phosphatase (ALP) compared with baseline.

Time Frame: Day85

Secondary Outcomes

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)