3 results
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites (PM) with a nasal provocation test in order to identify the optimal dose in terms of highest clinical efficacy and safety.
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 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…