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

To evaluate whether GS-9674 reduces the risk of fibrosis progression among non-cirrhotic 

subjects with PSC

Key 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

Key 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