Background
cirrhosis, liver disease, chronic progressive, cholestasis, PSC
CIRRHOSIS, LIVER DISEASE, CHOLESTASIS, PRIMARY SCLEROSING CHOLANGITIS, BILIARY FIBROSIS
Primary sclerosing cholangitis (PSC) is a chronic progressive liver disease leading to biliary fibrosis and cirrhosis. Cilofexor is a nonsteroidal farnesoid X receptor agonist that demonstrated significant improvements in liver biochemistry and markers of cholestasis in patients with PSC in a phase 2 study. We describe here the rationale, design, and implementation of the phase 3 PRIMIS trial, the largest placebo-controlled trial in PSC.