Ensayos clínicos

Inclusion Criteria

• Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months
• Serum alkaline phosphatase (ALP) > 1.67 x upper limit of the normal range (ULN)
• If on ursodeoxycholic acid (UDCA), dose must have been stable for at least 12 months prior to screening through the end of treatment
• If not on UDCA, then no UDCA use for at least 12 months before screening through the end of treatment
• Screening FibroSURE/FibroTest® < 0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis
  • With Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin

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
• 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 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.

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