" 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.
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).
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-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.
History of severe drug allergies.
Parallel
CS32582 capsule（low dose） or matched placebo
DrugCS32582 capsule（low dose） or matched placebo，4 weeks
CS32582 capsule（high dose） or matched placebo
DrugCS32582 capsule（high dose） or matched placebo，4 weeks
CS32582 capsule（low dose）
DrugCS32582 capsule（low dose），12 weeks
CS32582 capsule（medium dose）
DrugCS32582 capsule（medium dose），12 weeks
CS32582 capsule（high dose）
DrugCS32582 capsule（high dose），12 weeks
Part 1：Incidence and Severity of Adverse Events (AEs)
Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.
Part 1： Changes from baseline in PASI
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.
Part 1： Changes from baseline in sPGA
Static Physician's Global Assessment (sPGA) is an average assessment of all psoriatic lesions, with scores ranging from 0 (indicating clear) to 5 (indicating severe).
Part 1： Changes from baseline in BSA
Body Surface Area (BSA) scores range from 0% (indicating absence of lesions) to 100% (indicating total body surface involvement), with higher scores correlating to greater disease severity.
Part 1： Changes from baseline in DLQI
Dermatology Life Quality Index（DLQI) total score ranges from 0 (indicating no impairment in quality of life) to 30 (indicating maximum impairment in quality of life).
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