Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-12-01; most recent amendment 2026-07-07.
Status change: Active, Not Recruiting → Recruiting 2025-12-29
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-12-16
Trial Details
NCT Number NCT07282353
Lead Sponsor Cascade Pharmaceuticals, Inc
Conditions Primary Biliary Cholangitis
Enrollment 135 participants
Start Date 2025-12-01
Primary Completion 2027-12-09 (estimated)
Study Completion 2028-01-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-08