Conclusion
noncirrhotic large-duct, large-duct PSC, fibrosis
DISEASE, FIBROSIS, COMPLICATIONS
The PRIMIS trial is a pivotal phase 3 study designed to evaluate the long-term effects of cilofexor on fibrosis progression, liver biochemistry, and HRQOL, as well as PSC-related complications, over a 192-week treatment period in noncirrhotic patients with large-duct PSC. This study will provide valuable data on the natural history of PSC, with histologic and serologic assessments in patients receiving placebo over the 96-week blinded phase. This largest randomized controlled PSC study will allow for robust investigation of the long-term therapeutic efficacy and safety of cilofexor and should provide critical insights on the disease state and natural progression of noncirrhotic large-duct PSC.