Original study design
pruritus, NRS
The study was initially designed as a 12-month study where eligible patients were centrally randomized 1:1:1 through an interactive voice/web response system to receive seladelpar (CymaBay Therapeutics, Inc., Newark, CA) 5 or 10 mg QD orally or matching placebo following a 2-week screening period and subsequent 2-week run-in period. Patients and investigators were blinded to treatment, and blinding was maintained using a matched placebo. Patients were stratified by ALP level (<350 or ≥350 U/L) and pruritus numerical rating scale (NRS) (< 4 or ≥ 4). Patients receiving seladelpar 5 mg were to be uptitrated to 10 mg QD if they had not met the primary end point at month 6. Randomization occurred between November 26, 2018, and November 12, 2019.