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
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
Affiliated Hospital of Chengde Medical University
NOT_YET_RECRUITING
Chengde
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
NOT_YET_RECRUITING
Hangzhou
Shandong Provincial Hospital for Skin Diseases
NOT_YET_RECRUITING
Jinan
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shiyan People's Hospital
NOT_YET_RECRUITING
Shiyan
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The First Affliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
NOT_YET_RECRUITING
Xi’an
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Yiwu
Contact Information
Primary
Jianzhong Zhang
rmzjz@126.com
18001315877
Time Frame
Start Date:2025-09-08
Estimated Completion Date:2027-09-18
Participants
Target number of participants:220
Treatments
Experimental: Part 1：Low dose CS32582
The patient received low-dose CS32582 capsules BID or placebo for 4 weeks
Experimental: Part 1：Hgh dose CS32582
The patient received high-dose CS32582 capsules BID or placebo for 4 weeks
Experimental: Part 2：Low dose CS32582
The patient received low-dose CS32582 capsules BID or placebo for 12 weeks
Experimental: Part 2：Medium dose CS32582
The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks
Experimental: Part 2：High dose CS32582
The patient received high-dose CS32582 capsules BID or placebo for 12 weeks