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

NCT05190523 | Completed Phase 2

• 1 other identifier: ASC42-202
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis

Keywords

ASC42; primary biliary cholangitis; PBC

Outcome Measures

Primary Outcomes (1)

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

  Day85

Secondary Outcomes (3)

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

  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

• Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.

  Day15\29\57\85

Study Arms (4)

ASC42 tablets of 5mg

EXPERIMENTAL

ASC42 tablets 5mg for 12 weeks

Drug: ASC42 5 mg

ASC42 tablets of 10mg

EXPERIMENTAL

ASC42 tablets 10mg for 12 weeks

Drug: ASC42 10 mg

ASC42 tablets of 15mg

EXPERIMENTAL

ASC42 tablets 15mg for 12 weeks

Drug: ASC42 15 mg

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Drug: Placebo

Interventions

ASC42 5 mg DRUG

5 mg of ASC42 tablets orally once daily for 12 weeks.

ASC42 tablets of 5mg

ASC42 10 mg DRUG

2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.

ASC42 tablets of 10mg

ASC42 15 mg DRUG

15 mg of ASC42 tablets orally once daily for 12 weeks.

ASC42 tablets of 15mg

Placebo DRUG

Placebo tablets orally once daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ALT or AST \> 5× ULN; ALP \>10× ULN
• History or presence of other concomitant liver diseases
• Child-Pugh grade B or C

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 13, 2022
• Study Start: April 6, 2022
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (1)