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;
Parallel
2mg CS0159
DrugOral QD
Placebo
DrugOral QD
The proportion of patients who achieve the composite response criteria at Week 52
1. ALP \< 1.67×ULN 2. and ALP decrease of ≥15% 3. and TB ≤1.0× ULN
Response to treatment based on γ-glutamyl transpeptidase (GGT) normalization in patients with baseline GGT>1.0× ULN at Week 26 and Week 52
Response to treatment based on alanine aminotransferase (ALT) normalization in patients with baseline ALT >1.0× ULN at Week 26 and Week 52
Proportion of patients with ALP< 1.67× ULN and TB ≤1.0× ULN and ALP decrease of ≥15% from baseline at Week 26
Response to treatment based on AST normalization in patients with baseline AST>1.0× ULN at Week 26 and Week 52
Absolute changes of liver stiffness measured by iLivTouch
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