NCT07129382

A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	CS32582 capsule（low dose） or matched placebo	CS32582 capsule（low dose） or matched placebo，4 weeks
DRUG	CS32582 capsule（high dose） or matched placebo	CS32582 capsule（high dose） or matched placebo，4 weeks
DRUG	CS32582 capsule（low dose）	CS32582 capsule（low dose），12 weeks
DRUG	CS32582 capsule（medium dose）	CS32582 capsule（medium dose），12 weeks
DRUG	CS32582 capsule（high dose）	CS32582 capsule（high dose），12 weeks

Timeline

• Start date: 2025-09-08
• Primary completion: 2027-09-18
• Completion: 2027-09-18
• First posted: 2025-08-19
• Last updated: 2025-09-10

Locations

11 sites across 1 country: China