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
- Conditions
- Moderate to Severe Chronic Plaque Psoriasis
- Interventions
- Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Registration Number
- NCT05975268
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
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
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 747
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JS005 300mg (recombinant humanized monoclonal antibody against IL-17A) JS005 (recombinant humanized monoclonal antibody against IL-17A) - Placebo JS005 (recombinant humanized monoclonal antibody against IL-17A) - JS005 150mg (recombinant humanized monoclonal antibody against IL-17A) JS005 (recombinant humanized monoclonal antibody against IL-17A) -
- Primary Outcome Measures
Name Time Method Change in PASI 90 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 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.
- Secondary Outcome Measures
Name Time Method Patients achieving PASI 100 at Week 12 From week 0 to 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
Proportion of subjects with a DLQI score of 0/1 at week 12 From week 0 to week 12 The proportion of patients who with a DLQI score at least 0/1 at week 12
Time to sPGA 0/1 response From week 0 to week 12 Time to sPGA 0/1 response within 12 weeks
Time to PASI 75/90 response From week 0 to week 12 Time to PASI 75/90 response within 12 weeks
Patients achieving PASI 75 at Week 12 From week 0 to 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
Proportion of subjects with a sPGA score of 0 at week 12 From week 0 to week 12 The proportion of patients who achieved at least 0 at week 12
Patients achieving PASI 75 at Week 52 From week 0 to week 52 Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52
Patients achieving PASI 90 at Week 52 From week 0 to week 52 Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52
Patients achieving PASI 100 at Week 52 From week 0 to week 52 Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52
Related Research Topics
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Trial Locations
- Locations (63)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, Hebei, China
Nanyang city first People's Hospital
🇨🇳Nanyang, Henan, China
The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Wuhan University People's Hospital
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, Henan, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Wuxi Second People's Hospital
🇨🇳Wuxi, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
🇨🇳Ganzhou, Jiangxi, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, Shanghai, China
Medicine School of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Ningxia Medical University General Hospital
🇨🇳Yinchuan, Ningxia, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
🇨🇳Beijing, Beijing, China
Beijing LuHe Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Shiyan City People's Hospital
🇨🇳Shiyan, Hubei, China
Xiangya Third Hospital, Central South University
🇨🇳Changsha, Hunan, China
Lianyungang First People's Hospital
🇨🇳Lianyungang, Jiangsu, China
Yancheng First People's Hospital
🇨🇳Yancheng, Jiangsu, China
Jiangxi Dermatology Hospital
🇨🇳Nanchang, Jiangxi, China
Bethune First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Panjin Liao oil precious stone flower hospital
🇨🇳Panjin, Liaoning, China
Shengjing Hospital affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China
North East Central International Hospital Limited
🇨🇳Shenyang, Liaoning, China
Baotou Central Hospital
🇨🇳Baotou, Neimenggu, China
Inner Mongolia Baotou Steel Hospital
🇨🇳Baotou, Neimengu, China
Shandong Dermatology Hospital
🇨🇳Jinan, Shandong, China
The Second Hospital of Shanxi Medical University City:Taiyuan
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Shenyang Hospital of Integrated Chinese and Western Medicine
🇨🇳Shenyang, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian
🇨🇳Xi'an, Shanxi, China
Suining Central Hospital
🇨🇳Suining, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China