Phase III Study to Assess the Effectiveness and Safety of Oral ICP-488 in Adults With Moderate to Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating ICP-488 in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving Chinese adults with moderate to severe plaque psoriasis. The trial aims to assess the effectiveness, safety, and how the drug moves through the body pharmacokinetics in this patient group. Participants have a history of plaque psoriasis for at least six months and require systemic therapy or phototherapy. Participants will receive either oral ICP-488 tablets or a matching placebo according to the study protocol. The study includes random assignment to one of these two groups, and both participants and researchers are blinded to the treatment allocation. The primary treatment period lasts 16 weeks, with further follow-up extending to 52 weeks to monitor longer-term effects and safety. During the study, participants will undergo regular evaluations including assessments of skin clearance using the static Physicians Global Assessment sPGA and the Psoriasis Area and Severity Index PASI. Researchers will monitor adverse events and measure drug levels and metabolites at various points up to week 52. The study will also track improvements in skin condition and safety through planned visits, ensuring comprehensive observation throughout the trial period.

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis