Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis

Exclusion Criteria

• •Alanine aminotransferase (ALT) \> 10 x ULN
• •Total bilirubin \> 2 x ULN
• •International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
• •Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography)
• •Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions. Individuals with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy;
• •Ascending cholangitis within 60 days of screening
• •Presence of a percutaneous drain or bile duct stent
• •Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
• •Cirrhosis of the liver as defined by any of the following:
• •* Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
• •* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
• •* Liver stiffness \> 14.4 kilopascal (kPa) by FibroScan
• •Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of \> 1 and/or a score on the Rectal Bleeding domain \> 0.