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临床试验 NCT05975268 针对中度至重度慢性斑块型银屑病目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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君实生物A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis III期 747 随机化 双盲 安慰剂对照
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临床试验NCT05975268旨在研究治疗，主要针对中度至重度慢性斑块型银屑病。这是一项III期 干预性研究试验，试验状态为已完成。试验开始于2023年8月28日，共计划招募747名患者。该研究由君实生物主导，已于2025年9月3日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月16日。
简要概括
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...显示更多
官方标题
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
疾病
中度至重度慢性斑块型银屑病其他研究标识符
- JS005-005-III-PsO
NCT编号
实际开始日期
2023-08-28
最近更新发布
2025-12-16
预计完成日期
2025-09-03
计划入组人数
747
研究类型
干预性研究
试验分期 (阶段)
III期
试验状态
已完成
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性JS005 150mg (recombinant humanized monoclonal antibody against IL-17A) | JS005 (recombinant humanized monoclonal antibody against IL-17A) JS005/placebo |
实验性JS005 300mg (recombinant humanized monoclonal antibody against IL-17A) | JS005 (recombinant humanized monoclonal antibody against IL-17A) JS005/placebo |
安慰剂对照Placebo | JS005 (recombinant humanized monoclonal antibody against IL-17A) JS005/placebo |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in PASI 90 | The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12 | From week 0 to week 12 |
Change in sPGA | The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12. | From week 0 to week 12 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Patients achieving PASI 75 at Week 12 | The proportion of patients who achieved at least 75% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12 | From week 0 to week 12 |
Patients achieving PASI 100 at Week 12 | The proportion of patients who achieved at least 100% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12 | From week 0 to week 12 |
Proportion of subjects with a sPGA score of 0 at week 12 | The proportion of patients who achieved at least 0 at week 12 | From week 0 to week 12 |
Proportion of subjects with a DLQI score of 0/1 at week 12 | The proportion of patients who with a DLQI score at least 0/1 at week 12 | From week 0 to week 12 |
Patients achieving PASI 75 at Week 52 | Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52 | From week 0 to week 52 |
Time to PASI 75/90 response | Time to PASI 75/90 response within 12 weeks | From week 0 to week 12 |
Time to sPGA 0/1 response | Time to sPGA 0/1 response within 12 weeks | From week 0 to week 12 |
Patients achieving PASI 90 at Week 52 | Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52 | From week 0 to week 52 |
Patients achieving PASI 100 at Week 52 | Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52 | From week 0 to week 52 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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.
- 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;
君实生物没有联系数据。
63 位于 1 个国家/地区的研究中心
Anhui
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233004, China
The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230601, China
Beijing Municipality
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, 100044, China
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, Beijing Municipality, 100044, China
China-Japan Friendship Hospital, Beijing, Beijing Municipality, 100044, China
Peking University People's Hospital, Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital, Beijing, Beijing Municipality, 100044, China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences, Beijing, Beijing Municipality, 100864, China
Beijing LuHe Hospital Capital Medical University, Beijing, Beijing Municipality, 101199, China
Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, 102218, China
Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Fujian
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China
The Second Affiliated Hospital of Xiamen Medical College, Xiamen, Fujian, 361023, China
Gansu
Lanzhou University Second Hospital, Lanzhou, Gansu, 730030, China
Guangdong
Dongguan People's Hospital, Dongguan, Guangdong, 523018, China
Guangdong General Hospital, Guangzhou, Guangdong, 510080, China
Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, 510091, China
Guangzhou First People's Hospital, Guangzhou, Guangdong, 510180, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 518107, China
Shenzhen People's Hospital, Shenzhen, Guangdong, 518020, China
Hebei
The Affiliated Hospital of Chengde Medical College, Chengde, Hebei, China
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China
Xingtai People's Hospital, Xingtai, Hebei, 054031, China
Henan
Nanyang city first People's Hospital, Nanyang, Henan, 473000, China
The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, 453100, China
Hubei
Jingzhou Central Hospital, Jingzhou, Hubei, 434020, China
Shiyan City People's Hospital, Shiyan, Hubei, 442000, China
Wuhan University People's Hospital, Wuhan, Hubei, 430060, China
Hunan
The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China
Xiangya Third Hospital, Central South University, Changsha, Hunan, 410013, China
Jiangsu
Lianyungang First People's Hospital, Lianyungang, Jiangsu, 222002, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215123, China
Wuxi Second People's Hospital, Wuxi, Jiangsu, 214002, China
Yancheng First People's Hospital, Yancheng, Jiangsu, 224006, China
Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212000, China
Jiangxi
The First Affiliated Hospital of Gannan Medical College, Ganzhou, Jiangxi, 341000, China
Jiangxi Dermatology Hospital, Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Jilin
Bethune First Hospital of Jilin University, Changchun, Jilin, 130021, China
Liaoning
Panjin Liao oil precious stone flower hospital, Panjin, Liaoning, 124011, China
Shengjing Hospital affiliated to China Medical University, Shenyang, Liaoning, 110004, China
Shenyang Hospital of Integrated Chinese and Western Medicine, Shenyang, Liaoning, 110021, China
North East Central International Hospital Limited, Shenyang, Liaoning, China
Neimenggu
Baotou Central Hospital, Baotou, Neimenggu, 014040, China
Neimengu
Inner Mongolia Baotou Steel Hospital, Baotou, Neimengu, 010000, China
Ningxia
Ningxia Medical University General Hospital, Yinchuan, Ningxia, 750004, China
Shandong
Shandong Dermatology Hospital, Jinan, Shandong, 250000, China
Jinan Central Hospital, Jinan, Shandong, 250013, China
Shanghai Municipality
Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, 200050, China
Shanxi
The Second Hospital of Shanxi Medical University City:Taiyuan, Taiyuan, Shanxi, 030001, China
Medicine School of Xi'an Jiaotong University, Xian, Shanxi, 710004, China
The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian, Xi’an, Shanxi, 710061, China
Sichuan
Chengdu Second People's Hospital, Chengdu, Sichuan, 610017, China
West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
Suining Central Hospital, Suining, Sichuan, 629000, China
Tianjin Municipality
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, Tianjin Municipality, 300120, China
Yunnan
The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650118, China
Zhejiang
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310002, China
Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310006, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
The First Hospital of Jiaxing, Jiaxing, Zhejiang, 314001, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China