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
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
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).
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:
Key Exclusion Criteria:
Current or prior history of any of the following:
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
La Jolla, California 92037, United States
Sacramento, California 95817, United States
San Francisco, California 94107, United States
Manhasset, New York 11030, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27599, United States
Nashville, Tennessee 37232, United States
Dallas, Texas 75246, United States
Richmond, Virginia 23298, United States
Klagenfurt, 9020, Austria
Edmonton, T6G 2X8, Canada
Montreal, H2X 3J4, Canada
Vancouver, V5Z 1M9, Canada
Helsinki, 00290, Finland
CHRU Lille, 59000, France
Homburg, 66421, Germany
Toon-Shi, 791-0295, Japan