Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis

Open to people ages 18-75

• 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/mm³

• 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

• 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 severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply