NCT05190523

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Gannex Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-06
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2022-01-13
• Last updated: 2024-09-27

Locations

1 site across 1 country: China