Clinical Trials

Inclusion Criteria: 

• Diagnosis of large duct PSC.
• Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0. 
• F3 fibrosis in the opinion of the central reader. 
• Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: 
  • Platelet count ≥ 150,000/mm^3; 
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation;
  • ALT ≤ 8 x upper limit of the normal range (ULN);
  • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia; 
  • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation;
  • Negative anti-mitochondrial antibody.

Exclusion Criteria:

Current or prior history of any of the following:

• Cirrhosis; 
• Liver transplantation; 
• Cholangiocarcinoma or hepatocellular carcinoma (HCC); 
• Ascending cholangitis within 30 days of screening; 
• Presence of a percutaneous drain or biliary stent;
• Other causes of liver disease; 
• Current or prior history of unstable cardiovascular disease;
• Current moderate to severely active inflammatory bowel disease (IBD).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.