A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law; 2. When signing ICF age ≥18 years ≤75 years, male or female; 3. Meets the diagnostic criteria of PBC, based on any two of the following criteria: 1. History of ALP above 1.0× ULN for at least 6 months 2. Positive antimitochondrial antibody (AMA) titer (\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody (ANA) (either SP100 or GP210 positive) 3. Documented liver biopsy results consistent with PBC; 4. UDCA≥6 months before randomization and a stable dose ≥3 months after the efficacy was poor \[meeting inclusion criteria (5)a\], or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization); 5. Central laboratory parameters measured at screening period meet the following criteria: 1. ALP ≥1.67× ULN 2. ALT≤5× ULN 3. AST ≤5× ULN 4. TB \<2× ULN 5. Estimated glomerular filtration rate