A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Switching to Picankibart in Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)
研究概览
简要总结
This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years and ≤75 years.
- •Diagnosed with plaque psoriasis for ≥6 months, with or without psoriatic arthritis.
- •Regular use of secukinumab or ixekizumab according to the label information for at least 16 weeks prior to baseline (actual dose received ≥80% of the standard dose per instructions during the 16 weeks before baseline), with sufficient documented rationale for medication use.
- •At both screening and baseline, meet the criteria of sPGA (Static Physician's Global Assessment) ≥2 and body surface area (BSA) involvement ≥3%, along with the investigator's assessment of inadequate response to the original IL-17 monoclonal antibody therapy, warranting a switch to biologic treatment.
- •Full understanding of the trial objectives, basic knowledge of the pharmacological effects and potential adverse reactions of the investigational product, and voluntary provision of written informed consent in accordance with the principles of the Helsinki Declaration.
排除标准
- •Diagnosed with guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis during screening or at baseline;
- •Previous diagnosis of drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel inhibitors, etc.);
- •Prior use of picankibart or IL-23 inhibitors;
- •Received two biological agents for psoriasis treatment within 16 weeks prior to screening;
- •Received topical treatments that may affect psoriasis evaluation within 2 weeks before the first administration of the investigational product (including but not limited to glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, keratoplastics, and combination therapies);
- •Received conventional systemic medications that may affect psoriasis evaluation within 4 weeks before the first administration of the investigational product (including but not limited to methotrexate, cyclosporine, retinoids, azathioprine, leflunomide, mycophenolate mofetil, sulfasalazine, glucocorticoids, apremilast, JAK inhibitors such as tofacitinib/baricitinib/upadacitinib, TYK2 inhibitors such as deucravacitinib, or Chinese herbal medicines for psoriasis);
- •Use of natalizumab, or B-cell/T-cell modulators (e.g., rituximab, abatacept, visilizumab) within 12 months before the first administration of the investigational product;
- •Received phototherapy for psoriasis within 1 month before the first administration of the study drug, and/or unwillingness to avoid prolonged sun exposure and other UV light sources (e.g., sunbathing/tanning devices) during the study;
- •Received investigational biological agents within 6 months, any investigational therapy within 30 days, study drugs within 5 half-lives (whichever is longer), or current participation in clinical trials before the first administration of the investigational product.
研究组 & 干预措施
Picankibart treatment group
The participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.
干预措施: Picankibart (Drug)
Picankibart treatment group
The participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.
干预措施: Placebo (Drug)
IL-17 mAb continued treatment group
The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.
干预措施: Picankibart (Drug)
IL-17 mAb continued treatment group
The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.
干预措施: Secukinumab (Drug)
IL-17 mAb continued treatment group
The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.
干预措施: Placebo (Drug)
IL-17 mAb continued treatment group
The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)
时间窗: Week 16
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
次要结局
- The percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response(Week 16)
- The percentage of participants achieving a PASI 90 response(Week 44)
- The percentage of participants achieving sPGA=0(Week 44)
- The percentage of participants with involved body surface area (BSA) <3% (or ≥75% reduction relative to baseline)(Week 16)
- The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)(Week 44)
- The percentage of participants achieving Dermatology Life Quality Index (DLQI)=0/1 (for participants with baseline DLQI >1 only)(Week 16)
- The percentage of participants achieving a PASI 100 response(Week 44)
- The change from baseline in PASI score(Week 44)
- The change from baseline in involved BSA(Week 44)
- The percentage of participants achieving sPGA=0/1(Week 44)
- The percentage of participants with involved BSA<3% (or ≥75% reduction relative to baseline)(Week 44)
- The percentage of participants achieving DLQI=0/1 (for participants with baseline DLQI >1 only)(Week 44)
- The percentage of participants achieving a PASI 75 response(Week 44)