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

• Status: Active, not recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

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 severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply