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).
Must have given written informed consent (signed and dated) and any authorizations required by local law;
When signing ICF age ≥18 years ≤75 years, male or female;
History of ALP above 1.0× ULN for at least 6 months
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)
Previous exposure to CS0159;
History of allergy to the CS0159 or its excipients or drugs of similar chemical classes;
Advanced PBC as defined by the Rotterdam criteria (albumin<1.0×LLN AND TB >1.0× ULN);
History of liver transplantation, current placement on a liver transplant list, current MELD -Na score ≥ 12;