A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 747
- 试验地点
- 63
- 主要终点
- Change in PASI 90
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with moderate-to-severe chronic plaque psoriasis
详细描述
The study consisted of four periods: screening period (up to 4 weeks), induction period (12 weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were stratified by whether they had previsouly received biologic treatments (continuous biologic treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body weight (≥70 kg or < 70 kg).
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)
盲法说明
The study uses a double-blind design in which subjects, investigators, and other researchers will remain blind to the allocation of the study drug and placebo.
If serious adverse events occur to subjects during the study, the investigator must be informed of the treatment received by the subjects before appropriate treatment can be given. For safety reasons, the investigator may unblind the subjects urgently after obtaining the consent of the sponsor's medical monitor.
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
- •Subjects voluntarily particpate in this clinical study and sign the informed consent form.
- •Male and female patients aged 18-75 years at the time of screening (both inclusive).
- •Fertile female subjects must be willing to use a highly effective contraceptive method during the study period and 20 weeks (expected 5 half-lives) after the last study drug administration and have a negative pregnancy test during the screening period and prior to randomization.
排除标准
- •Pregnant and lactating women.
- •A history of inflammatory bowel disease or other conditions with a high risk of perforation (e.g., severe gastrointestinal ulcers, etc.) or with other active autoimmune diseases (e.g., systemic lupus erythematosus, Sarcoidosis, etc.).
- •Have a type of psoriasis other than chronic plaque psoriasis (e.g., pustular, erythrodermic, and guttate psoriasis), drug-induced psoriasis, or have an active inflammatory skin disease other than psoriasis
- •Use of phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Subjects are unwilling to avoid excessive sunlight exposure within 4 weeks prior to randomization and during the study period;
- •A (current) history of systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviral agents) within 12 weeks prior to randomization; a history of any active infection, other than common upper respiratory infections, within 2 weeks prior to randomization;
研究组 & 干预措施
JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)
干预措施: JS005 (recombinant humanized monoclonal antibody against IL-17A) (Biological)
JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)
干预措施: JS005 (recombinant humanized monoclonal antibody against IL-17A) (Biological)
Placebo
干预措施: JS005 (recombinant humanized monoclonal antibody against IL-17A) (Biological)
结局指标
主要结局
Change in PASI 90
时间窗: From week 0 to week 12
The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
Change in sPGA
时间窗: From week 0 to week 12
The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.
次要结局
- Patients achieving PASI 100 at Week 12(From week 0 to week 12)
- Proportion of subjects with a DLQI score of 0/1 at week 12(From week 0 to week 12)
- Time to sPGA 0/1 response(From week 0 to week 12)
- Time to PASI 75/90 response(From week 0 to week 12)
- Patients achieving PASI 75 at Week 12(From week 0 to week 12)
- Proportion of subjects with a sPGA score of 0 at week 12(From week 0 to week 12)
- Patients achieving PASI 75 at Week 52(From week 0 to week 52)
- Patients achieving PASI 90 at Week 52(From week 0 to week 52)
- Patients achieving PASI 100 at Week 52(From week 0 to week 52)