Cilofexor Did Not Prevent Fibrosis Progression in Non‑Cirrhotic Primary Sclerosing Cholangitis: Results from the PRIMIS Phase 3 Trial

Highlight

– In the phase 3 PRIMIS trial, cilofexor 100 mg daily did not significantly reduce the proportion of patients with histological fibrosis progression (Ludwig stage increase ≥1) at 96 weeks compared with placebo in non‑cirrhotic large‑duct primary sclerosing cholangitis (PSC).

– Fibrosis progression occurred in 31% of cilofexor‑treated patients versus 33% with placebo (treatment difference −1.4%; 95% CI −15.2 to 12.3; p=0.42); the study was stopped early for futility.