A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

Exclusion Criteria

• •1. Clinically significant acute or chronic liver disease of an etiology other than PSC
• •2. Patients with a diagnosis of overlapping autoimmune hepatitis (AIH) and PSC
• •3. Secondary or immunoglobulin G4 (IgG4) related sclerosing cholangitis
• •4. Small duct PSC
• •5. Presence of a cholangiocarcinoma on cholangiography or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or medical monitor
• •6. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
• •7. History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms
• •8. Presumptive or diagnosed acute cholangitis within 12 weeks of Screening and through Day 1
• •9. Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:
• •* Historical liver biopsy demonstrating cirrhosis (eg, Ludwig Stage 4 or Ishak Stage 5)
• •* Current or prior history of decompensated liver disease, including ascites, hepatic encephalopathy, variceal bleeding or other clinical conditions consistent with cirrhosis and/or portal hypertension,
• •* Liver stiffness \> 14.4 kPa by FibroScan, or
• •* Combined low platelet count (\< 140 × 10\^3/µL ) with one of the following:
• •* Serum albumin \< 3.5 g/dL,
• •* INR \> 1.3 (not due to antithrombotic agent use), or
• •* Total bilirubin \> ULN
• •10. Prior or actively listed for liver transplantation
• •11. Prior exposure to seladelpar