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

NCT05190523 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-09-27

No results posted yet for this study

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

Interventions

DRUG

ASC42 5 mg

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

DRUG

ASC42 10 mg

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

DRUG

ASC42 15 mg

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

DRUG

Placebo

Placebo tablets orally once daily for 12 weeks.

Sponsors & Collaborators

  • Gannex Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2024-03-13
Completion
2024-03-13

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190523 on ClinicalTrials.gov