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NCT Number: NCT05190523

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC42 5 mg

Drug

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

ASC42 10 mg

Drug

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

ASC42 15 mg

Drug

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

Placebo

Drug

Placebo tablets orally once daily for 12 weeks.

Primary outcomes

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

    Time frame: Day85

Secondary outcomes

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

    Time frame: Day15\29\57\85

  2. Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.

    Time frame: Day15\29\57\85

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

    Time frame: Day15\29\57\85

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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