5 results
Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…
Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…
Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1), administered once daily (QD) or twice…