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

Primary Biliary Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190523
• Other study ID #: ASC42-202
• Status: Completed
• Phase: Phase 2
• Start date: April 6, 2022
• Est. completion date: March 13, 2024

Study information

• Verified date: April 2024
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• ASC42 5 mg
5 mg of ASC42 tablets orally once daily for 12 weeks.
• ASC42 10 mg
2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.
• ASC42 15 mg
15 mg of ASC42 tablets orally once daily for 12 weeks.
• Placebo
Placebo tablets orally once daily for 12 weeks.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage changes of alkaline phosphatase (ALP) compared with baseline.		Day85
Secondary	Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.		Day15\29\57\85
Secondary	Percentage changes and absolute changes of serum ?-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.		Day15\29\57\85
Secondary	Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.		Day15\29\57\85