A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Trial Parameters
Brief Summary
" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks. Part 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment. The resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.
Eligibility Criteria
Inclusion Criteria: * Voluntarily sign the informed consent form (ICF) after fully understanding the trial. * Age 18-70 years (inclusive) at consent, any gender * Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening. * Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed). * Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%; * Candidate for phototherapy or systemic therapy per investigator's judgment. * Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose. Exclusion Criteria: * Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) . * Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment. * Immune-mediat