A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis

Condition studied

Prurigo Nodularis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16.

Endpoint detail

Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time., Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time, Proportion of participants achieving both PP NRS ≥ 4 and IGA-CPG-S 0/1 over time., Percent change from baseline of weekly average in PP NRS over time., Change from baseline in Dermatology Life Quality Index (DLQI) score over time, Safety as assessed by the nature, severity, and incidence of adverse events (AEs); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameters., PK endpoints: Cmax, AUC, etc