NCT07282353

A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA

A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients With Primary Biliary Cholangitis (PBC) With Inadequate Response or Intolerance to Ursodeoxycholic Acid (UDCA)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).

Detailed description

This is an multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluates the efficacy and safety of CS0159 in patients with PBC who have inadequate response or intolerance to ursodeoxycholic acid (UDCA). Approximately 135 participants will be randomized in a 2:1 ratio to receive CS0159 (4 mg) or placebo, once daily, for a maximum of 52 weeks. When applicable, study participants should continue their pre-study dose of UDCA.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	2mg CS0159	Oral QD
DRUG	Placebo	Oral QD

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-09
• Completion: 2028-01-06
• First posted: 2025-12-15
• Last updated: 2025-12-30

Locations

41 sites across 1 country: China