Phase 2 Study of ICP-332 Tablets for Treating Prurigo Nodularis in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the efficacy and safety of ICP-332 in adults aged 18 to 75 years with Prurigo Nodularis PN, a chronic skin condition characterized by itchy nodules. This phase 2, randomized, double-blind, placebo-controlled study aims to investigate different doses of ICP-332 for treating PN, addressing the need for effective therapies in patients with this condition. The trial is sponsored by Beijing InnoCare Pharma Tech Co., Ltd. and uses a parallel study design with multiple groups. Participants are randomly assigned to receive either ICP-332 at doses of 80 mg or 120 mg or a placebo. The study compares these groups over a period of up to 40 weeks, with primary assessment focusing on peak itch intensity using a numeric rating scale from baseline to week 16. Secondary measures include longer-term itch improvement, skin condition scores, quality of life assessments, drug concentration levels, and safety monitoring of adverse events from baseline through week 40. During the trial, participants will undergo regular evaluations including itch severity scales, skin assessments, quality of life questionnaires, and laboratory tests to monitor drug levels and safety. The study tracks outcomes up to 40 weeks to assess both efficacy and tolerability. Participants are expected to adhere to study visits and procedures as scheduled, with safety and treatment response closely monitored throughout the trial duration.

Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis