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" 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1:Low dose CS32582 | Experimental | The patient received low-dose CS32582 capsules BID or placebo for 4 weeks |
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| Part 1:Hgh dose CS32582 | Experimental | The patient received high-dose CS32582 capsules BID or placebo for 4 weeks |
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| Part 2:Low dose CS32582 | Experimental | The patient received low-dose CS32582 capsules BID or placebo for 12 weeks |
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| Part 2:Medium dose CS32582 | Experimental | The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks |
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| Part 2:High dose CS32582 | Experimental | The patient received high-dose CS32582 capsules BID or placebo for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS32582 capsule(low dose) or matched placebo | Drug | CS32582 capsule(low dose) or matched placebo,4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1:Incidence and Severity of Adverse Events (AEs) | 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Part 1: Changes from baseline in sPGA |
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Inclusion Criteria:
Exclusion Criteria:
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.
Major surgery within 2 months before randomization or planned during the study.
Drug/alcohol abuse within 6 months before screening.
Uncontrolled hypertension at screening (SBP >160 mmHg or DBP >100 mmHg).
Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.
NYHA Class III/IV heart failure at screening.
History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).
Prosthetic joint infection (unless prosthesis removed/replaced ≥2 months before randomization).
History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).
Active/latent TB infection (positive IGRA without clinical manifestations).
Herpes infection:a) Active herpes zoster/simplex (HSV-1/2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster [≥2 episodes in 2 years]).
History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.
History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.
Evidence of active infection and/or febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.
Abnormal virology at screening:
Prior use of TYK2 inhibitors (e.g., deucravacitinib).
Use of any of the following therapeutic agents within 6 months before randomization:
Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B/T-cell modulators (alemtuzumab, abatacept, vedolizumab).
Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.
Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.
Use of systemic non-biologic psoriasis agents and/or any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral/injectable corticosteroids, retinoids, calcitriol/analogs, psoralen, sulfasalazine, fumarates).
Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.
Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.
Received phototherapy within 4 weeks before randomization.
Use of medicated shampoos and/or body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, >3% salicylic acid, vitamin D3 analogs.
Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.
Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.
Laboratory values meeting any of the following criteria during screening or before randomization:
Pregnant or lactating women.
Any condition deemed unsuitable by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianzhong Zhang | Contact | 18001315877 | rmzjz@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| CS32582 capsule(high dose) or matched placebo | Drug | CS32582 capsule(high dose) or matched placebo,4 weeks |
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| CS32582 capsule(low dose) | Drug | CS32582 capsule(low dose),12 weeks |
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| CS32582 capsule(medium dose) | Drug | CS32582 capsule(medium dose),12 weeks |
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| CS32582 capsule(high dose) | Drug | CS32582 capsule(high dose),12 weeks |
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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).
| 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. | 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). | 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. | Week 4 |
| Part 2:Incidence and Severity of Adverse Events (AEs) | 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. | 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. | 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 | 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. | 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. | 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). | 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). | Week 4,8 and 12 |
| Pharmacokinetic parameters - Area Under the Curve(AUC) | Day 1~Day 85 |
| Pharmacokinetic parameters - Peak Plasma Concentration (Cmax) | Day 1~Day 85 |
| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Affiliated Hospital of Chengde Medical University | Not yet recruiting | Chengde | Hebei | China |
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| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Shiyan People's Hospital | Not yet recruiting | Shiyan | Hubei | China |
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| Shandong Provincial Hospital for Skin Diseases | Not yet recruiting | Jinan | Shandong | China |
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| First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital ) | Not yet recruiting | Xi’an | Shanxi | China |
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| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Yiwu | Zhejiang | China |
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| The First Affliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhengjiang | China |
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