About this trial
" 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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CS32582 capsule(low dose) or matched placebo
- CS32582 capsule(high dose) or matched placebo
- CS32582 capsule(low dose)
- CS32582 capsule(medium dose)
- CS32582 capsule(high dose)