A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

GS-US-428-4194

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).

2019-03-27

2022-11-10

2022-12-23

Terminated

Early phase I

419

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 * Alanine transaminase (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

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2023-11-29