Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor
 in adults with primary biliary cholangitis (PBC).
Key Inclusion Criteria:

 -  Meets all of the following conditions

 -  Definite or probable PBC as defined by at least 2 of the 3 following criteria:

 -  Serum alkaline phosphatase (ALP) > the upper limit of normal (ULN)

 -  Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on
 immunofluorescence)

 -  Liver histological findings consistent with PBC including nonsuppurative,
 destructive cholangitis affecting mainly the interlobular bile and septal
 bile ducts

 -  Serum ALP > 1.67 x ULN and/or total bilirubin >ULN but ≤ 2 x ULN

 -  Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or
 intolerant of UDCA with no UDCA use for at least 12 months before screening

 -  Screening FibroSURE/FibroTest® < 0.75 unless a historical liver biopsy within 12
 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or
 hemolysis, FibroSURE/FibroTest will be calculated using direct bilirubin instead of
 total bilirubin.

 Key Exclusion Criteria:

 -  Alanine aminotransferase (ALT) > 5 x ULN

 -  Total bilirubin > 2 x ULN

 -  International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

 -  Other causes of liver disease including viral, metabolic, alcoholic, and other
 autoimmune conditions. Participants 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.

 -  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)

 -  History of decompensated liver disease, including ascites, hepatic encephalopathy
 or variceal bleeding

 -  Liver stiffness > 16.9 kPa by FibroScan®

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