Phase III Study of CS0159 to Evaluate Safety and Effectiveness in Adults with Primary Biliary Cholangitis Not Responding to or Intolerant of Ursodeoxycholic Acid

What this Trial Is About

Researchers are evaluating the drug CS0159 in a Phase III clinical trial for patients with Primary Biliary Cholangitis PBC who have an inadequate response or intolerance to ursodeoxycholic acid UDCA. This randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of CS0159 in this population. The study involves approximately 135 participants and is sponsored by Cascade Pharmaceuticals, Inc. Participants will be randomly assigned in a 21 ratio to receive either 4 mg of CS0159 or a placebo once daily for up to 52 weeks. Participants who are already taking UDCA should continue their stable dose during the study if applicable. The study compares the effects of CS0159 against placebo while monitoring participants over one year. During the study, participants will undergo various assessments including laboratory tests to monitor liver function and safety. Researchers will measure the proportion of patients achieving a composite response at 52 weeks as the primary outcome. Secondary outcomes include normalization of liver enzymes and monitoring of adverse events. The total participation period lasts up to 52 weeks, with ongoing safety monitoring throughout the trial.

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