NCT07129382招募中1 期
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
Chipscreen Biosciences, Ltd.11 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 11
- 主要终点
- Part 1：Incidence and Severity of Adverse Events (AEs)
研究概览
简要总结
" 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •HBsAg(+) or HBcAb(+) with detectable HBV-DNA
- •HCV Ab(+) with detectable HCV-RNA
- •History of HIV infection or HIV Ab(+)
- •Treponema pallidum Ab(+) with positive RPR/TRUST
- •Prior use of TYK2 inhibitors (e.g., deucravacitinib).
- •Use of any of the following therapeutic agents within 6 months before randomization:
- •IL-12/23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)
- •Rituximab or other B-cell depleting agents
- •Leflunomide
- •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:
- •Liver: ALT/AST ≥3×ULN; total bilirubin >2×ULN
- •Hematology: WBC <3.0×10⁹/L (3000/mm³); ANC <1.0×10⁹/L (1000/mm³); lymphocyte count <0.5×10⁹/L (500/mm³); platelets <100×10⁹/L (100,000/mm³); hemoglobin <9.0 g/dL (90 g/L)
- •Renal: eGFR <60 mL/min/1.73m² (CKD-EPI equation)
- •Pregnant or lactating women.
- •Any condition deemed unsuitable by the investigator.
研究组 & 干预措施
Part 2：Medium dose CS32582
Experimental
The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks
干预措施: CS32582 capsule（medium dose） (Drug)
Part 2：High dose CS32582
Experimental
The patient received high-dose CS32582 capsules BID or placebo for 12 weeks
干预措施: CS32582 capsule（high dose） (Drug)
Part 2：Low dose CS32582
Experimental
The patient received low-dose CS32582 capsules BID or placebo for 12 weeks
干预措施: CS32582 capsule（low dose） (Drug)
Part 1：Hgh dose CS32582
Experimental
The patient received high-dose CS32582 capsules BID or placebo for 4 weeks
干预措施: CS32582 capsule（high dose） or matched placebo (Drug)
Part 1：Low dose CS32582
Experimental
The patient received low-dose CS32582 capsules BID or placebo for 4 weeks
干预措施: CS32582 capsule（low dose） or matched placebo (Drug)
结局指标
主要结局
Part 1：Incidence and Severity of Adverse Events (AEs)
时间窗: 5 weeks
Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12
时间窗: 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.
次要结局
- Part 1： Changes from baseline in PASI(Week 4)
- Part 1： Changes from baseline in sPGA(Week 4)
- Part 1： Changes from baseline in BSA(Week 4)
- Part 1： Changes from baseline in DLQI(Week 4)
- Part 1：Proportion of patients achieving PASI 50/75/90/100(Week 4)
- Part 2：Incidence and Severity of Adverse Events (AEs)(16 weeks)
- Part 2：Proportion of patients achieving PASI 75(Week 4 and 8)
- Part 2：Proportion of patients achieving PASI 50/90/100(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(Week 4，8 and 12)
- Part 2： Changes from baseline in BSA(Week 4，8 and 12)
- Part 2： Changes from baseline in sPGA(Week 4，8 and 12)
- Part 2： Changes from baseline in DLQI(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)
研究者
研究点 (11)
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