" 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
CS32582 capsule(low dose) or matched placebo,4 weeks
CS32582 capsule(high dose) or matched placebo,4 weeks
CS32582 capsule(low dose),12 weeks
CS32582 capsule(medium dose),12 weeks
CS32582 capsule(high dose),12 weeks
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGAffiliated Hospital of Chengde Medical University
Chengde, Hebei, China
NOT_YET_RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGShiyan People's Hospital
Shiyan, Hubei, China
NOT_YET_RECRUITINGShandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China
NOT_YET_RECRUITINGFirst Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi’an, Shanxi, China
NOT_YET_RECRUITINGAffiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
NOT_YET_RECRUITING...and 1 more locations
Part 1:Incidence and Severity of Adverse Events (AEs)
Time frame: 5 weeks
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.
Time frame: Week 12
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.
Time frame: Week 4
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).
Time frame: Week 4
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.
Time frame: Week 4
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).
Time frame: Week 4
Part 1:Proportion of patients achieving PASI 50/75/90/100
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.
Time frame: Week 4
Part 2:Incidence and Severity of Adverse Events (AEs)
Time frame: 16 weeks
Part 2:Proportion of patients achieving PASI 75
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.
Time frame: Week 4 and 8
Part 2:Proportion of patients achieving PASI 50/90/100
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.
Time frame: Week 4,8 and 12
Part 2:Proportion of patients achieving: (a) sPGA score of 0 or 1 with ≥2-point reduction from baseline (b) sPGA clearance (score 0) (c) Disease remission
Time frame: Week 4,8 and 12
Part 2: 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.
Time frame: Week 4,8 and 12
Part 2: 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.
Time frame: Week 4,8 and 12
Part 2: 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).
Time frame: Week 4,8 and 12
Part 2: 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).
Time frame: Week 4,8 and 12
Pharmacokinetic parameters - Area Under the Curve(AUC)
Time frame: Day 1~Day 85
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Time frame: Day 1~Day 85
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