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

September 25, 2024 updated by: Gannex Pharma Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks
Drug: Placebo
Placebo tablets orally once daily for 12 weeks.
Experimental: ASC42 tablets of 5mg
ASC42 tablets 5mg for 12 weeks
Drug: ASC42 5 mg
5 mg of ASC42 tablets orally once daily for 12 weeks.
Experimental: ASC42 tablets of 10mg
ASC42 tablets 10mg for 12 weeks
Drug: ASC42 10 mg
2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.
Experimental: ASC42 tablets of 15mg
ASC42 tablets 15mg for 12 weeks
Drug: ASC42 15 mg
15 mg of ASC42 tablets orally once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage changes of alkaline phosphatase (ALP) compared with baseline.
Time Frame: Day85
Day85

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.
Time Frame: Day15\29\57\85
Day15\29\57\85
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
Day15\29\57\85
Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.
Time Frame: Day15\29\57\85
Day15\29\57\85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gannex Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Actual)

March 13, 2024

Study Completion (Actual)

March 13, 2024

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC42-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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