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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects voluntarily particpate in this clinical study and sign the informed consent form. 2. Male and female patients aged 18-75 years at the time of screening (both inclusive). 3. 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.

Exclusion Criteria:

1. Pregnant and lactating women. 2. 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.). 3. 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. 4. 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; 5. 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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05975268
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Junshi Bioscience Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Chronic Plaque Psoriasis
Additional Details

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).

Arms & Interventions

Arms

Experimental: JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)

Experimental: JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)

Placebo Comparator: Placebo

Interventions

Biological: - JS005 (recombinant humanized monoclonal antibody against IL-17A)

JS005/placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004

Site Contact

Hongfang Han, M.D.

627075942@qq.com

8613865019127

Hefei, Anhui, China

Status

Recruiting

Address

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601

Site Contact

Chunjun Yang, M.D.

aydefyllwyhbgs@163.com

8613966681316

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, 100044

Site Contact

Lingfeng Li, M.D.

zoonli@sina.com

8613693620186

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing, 100044

Site Contact

Aihua Wei, M.D.

weiaihua3000@163.com

8615810585889

China-Japan Friendship Hospital, Beijing, Beijing, China

Status

Recruiting

Address

China-Japan Friendship Hospital

Beijing, Beijing, 100044

Site Contact

Yong Cui, M.D.

wuhucuiyong@vip.163.com

8617150070682

Peking University People's Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University People's Hospital

Beijing, Beijing, 100044

Site Contact

Jianzhong Zhang, M.D.

Rmzjz@126.com

+8618001315877

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100044

Site Contact

Wenhui Wang, M.D.

wwh0608@126.com

8618618269437

Beijing, Beijing, China

Status

Recruiting

Address

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Beijing, Beijing, 100864

Site Contact

Jinyan Wang, M.D.

rypamy@163.com

8613586795265

Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing LuHe Hospital Capital Medical University

Beijing, Beijing, 101199

Site Contact

Lingling Zheng, Doctor

13521089625@163.com

13521089625

Beijing Tsinghua Changgung Hospital, Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Tsinghua Changgung Hospital

Beijing, Beijing, 102218

Site Contact

Yi Zhao, Doctor

zhaoyimd@163.com

13718646181

Chongqing, Chongqing, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing, 400016

Site Contact

Aijun Chen, M.D.

1360999716@qq.com

8613062377863

Fuzhou, Fujian, China

Status

Terminated

Address

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005

Xiamen, Fujian, China

Status

Recruiting

Address

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, 361023

Site Contact

Mingkai Ji, M.D.

Mingkai_ji@163.com

8613075959049

Lanzhou University Second Hospital, Lanzhou, Gansu, China

Status

Recruiting

Address

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030

Site Contact

Taoxiang Niu, M.D.

niutx@163.com

8615193189096

Dongguan People's Hospital, Dongguan, Guangdong, China

Status

Recruiting

Address

Dongguan People's Hospital

Dongguan, Guangdong, 523018

Site Contact

Guangming Han, M.D.

Ghan54321@163.com

8613533391069

Guangdong General Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong General Hospital

Guangzhou, Guangdong, 510080

Site Contact

Zhu Shen, M.D.

zhshencq@163.com

8613983174426

Guangzhou, Guangdong, China

Status

Recruiting

Address

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091

Site Contact

Xiaohua Wang, M.D.

wxh-21773@163.com

8613763359607

Guangzhou First People's Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180

Site Contact

Jiang Wu, M.D.

wj642@163.com

8618922182868

Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 518107

Site Contact

Qing Guo, M.D.

guoqingzsy@163.com

8618922182868

Shenzhen People's Hospital, Shenzhen, Guangdong, China

Status

Recruiting

Address

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020

Site Contact

Jianglin Zhang, M.D.

zhang.jianglin@szhospital.com

8613873143466

Chengde, Hebei, China

Status

Recruiting

Address

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei,

Site Contact

Xisuo Duan, M.D.

15633142680@163.com

8615633142680

Shijiazhuang, Hebei, China

Status

Recruiting

Address

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000

Site Contact

Guoqiang Zhang, M.D.

zgq810328@sina.com

8618633888122

Xingtai People's Hospital, Xingtai, Hebei, China

Status

Recruiting

Address

Xingtai People's Hospital

Xingtai, Hebei, 054031

Site Contact

Fang Cheng, M.D.

18931912286@163.com

8618931912286

Nanyang city first People's Hospital, Nanyang, Henan, China

Status

Recruiting

Address

Nanyang city first People's Hospital

Nanyang, Henan, 473000

Site Contact

Rixin Chen, M.D.

pfkgcpby@163.com

8613849795170

Xinxiang, Henan, China

Status

Recruiting

Address

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453100

Site Contact

Zhongwei Tian, M.D.

zhonwt@xxmu.edu.cn

8615637358828

Jingzhou Central Hospital, Jingzhou, Hubei, China

Status

Recruiting

Address

Jingzhou Central Hospital

Jingzhou, Hubei, 434020

Site Contact

Tongxiang Zeng, M.D.

331867948@qq.com

8613339737387

Shiyan City People's Hospital, Shiyan, Hubei, China

Status

Recruiting

Address

Shiyan City People's Hospital

Shiyan, Hubei, 442000

Site Contact

Zudong Meng, M.D.

1970547910@qq.com

8613997837543

Wuhan University People's Hospital, Wuhan, Hubei, China

Status

Recruiting

Address

Wuhan University People's Hospital

Wuhan, Hubei, 430060

Site Contact

Tiechi Lei, M.D.

tiechilei@126.com

8615337173507

Changsha, Hunan, China

Status

Recruiting

Address

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410008

Site Contact

Rong Xiao, M.D.

xiaorong65@aliyun.com

8613808425555

Changsha, Hunan, China

Status

Recruiting

Address

Xiangya Third Hospital, Central South University

Changsha, Hunan, 410013

Site Contact

Jianyun Lu, M.D.

1010739024@qq.com

8613975130008

Lianyungang First People's Hospital, Lianyungang, Jiangsu, China

Status

Terminated

Address

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222002

Suzhou, Jiangsu, China

Status

Recruiting

Address

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215123

Site Contact

Jisheng Liu, M.D.

yzl6405@163.com

8613913719333

Wuxi Second People's Hospital, Wuxi, Jiangsu, China

Status

Recruiting

Address

Wuxi Second People's Hospital

Wuxi, Jiangsu, 214002

Site Contact

Xiaohong Zhu, M.D.

zxh6801@126.com

8613395172837

Yancheng First People's Hospital, Yancheng, Jiangsu, China

Status

Recruiting

Address

Yancheng First People's Hospital

Yancheng, Jiangsu, 224006

Site Contact

Pingping Qin, M.D.

ycyylwh@163.com

8613601413122

Zhenjiang, Jiangsu, China

Status

Recruiting

Address

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000

Site Contact

Yumei Li, M.D.

yumei@aliyun.com

8613914569541

Ganzhou, Jiangxi, China

Status

Recruiting

Address

The First Affiliated Hospital of Gannan Medical College

Ganzhou, Jiangxi, 341000

Site Contact

Jingfa Lu, M.D.

lujingfa@126.com

8613479725817

Jiangxi Dermatology Hospital, Nanchang, Jiangxi, China

Status

Recruiting

Address

Jiangxi Dermatology Hospital

Nanchang, Jiangxi, 330000

Site Contact

Fengming Hu, M.D.

1262200957@qq.com

8618907802429

Nanchang, Jiangxi, China

Status

Recruiting

Address

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006

Site Contact

Meiying Jiang, M.D.

151465672@qq.com

8613870913263

Changchun, Jilin, China

Status

Recruiting

Address

Bethune First Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Shanshan Li, M.D

shansalee@163.com

8613756661632

Panjin, Liaoning, China

Status

Recruiting

Address

Panjin Liao oil precious stone flower hospital

Panjin, Liaoning, 124011

Site Contact

Yingxia He, M.D.

1462619572@qq.com

8613904273211

Shenyang, Liaoning, China

Status

Active, not recruiting

Address

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004

Shenyang, Liaoning, China

Status

Recruiting

Address

Shenyang Hospital of Integrated Chinese and Western Medicine

Shenyang, Liaoning, 110021

Site Contact

Xiaodong Sun, M.D.

gemmapeter@163.com

8613591454517

Shenyang, Liaoning, China

Status

Recruiting

Address

North East Central International Hospital Limited

Shenyang, Liaoning,

Site Contact

Shifa Zhang, M.D.

zhangshifa_1963@126.com

8613190010100

Baotou Central Hospital, Baotou, Neimenggu, China

Status

Active, not recruiting

Address

Baotou Central Hospital

Baotou, Neimenggu, 014040

Inner Mongolia Baotou Steel Hospital, Baotou, Neimengu, China

Status

Recruiting

Address

Inner Mongolia Baotou Steel Hospital

Baotou, Neimengu, 010000

Site Contact

Min Zhang, M.D.

nmgzm@126.com

8613847245128

Yinchuan, Ningxia, China

Status

Recruiting

Address

Ningxia Medical University General Hospital

Yinchuan, Ningxia, 750004

Site Contact

Nan Yu, M.D.

13895095009@163.com

8613895095009

Shandong Dermatology Hospital, Jinan, Shandong, China

Status

Not yet recruiting

Address

Shandong Dermatology Hospital

Jinan, Shandong, 250000

Site Contact

Furen Zhang, M.D.

zhangfuren@hotmail.com

8613608921718

Jinan Central Hospital, Jinan, Shandong, China

Status

Recruiting

Address

Jinan Central Hospital

Jinan, Shandong, 250013

Site Contact

Lihua Wang, M.D.

15318816237@163.com

8615318816237

Shanghai Dermatology Hospital, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Shanghai Dermatology Hospital

Shanghai, Shanghai, 200050

Site Contact

Yangfeng Ding, M.D.

dingyangfeng@aliyun.com

8618017336636

Taiyuan, Shanxi, China

Status

Recruiting

Address

The Second Hospital of Shanxi Medical University City:Taiyuan

Taiyuan, Shanxi, 030001

Site Contact

Wenli Feng, M.D.

fwl92@hotmail.com

8613935198008

Xi'an, Shanxi, China

Status

Terminated

Address

The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian

Xi'an, Shanxi, 710061

Xian, Shanxi, China

Status

Active, not recruiting

Address

Medicine School of Xi'an Jiaotong University

Xian, Shanxi, 710004

Chengdu Second People's Hospital, Chengdu, Sichuan, China

Status

Recruiting

Address

Chengdu Second People's Hospital

Chengdu, Sichuan, 610017

Site Contact

Yanyan Feng, M.D.

fyymed@163.com

8619150169967

Chengdu, Sichuan, China

Status

Not yet recruiting

Address

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041

Site Contact

Wei Li, M.D.

724564806@qq.com

8618980601695

Suining Central Hospital, Suining, Sichuan, China

Status

Recruiting

Address

Suining Central Hospital

Suining, Sichuan, 629000

Site Contact

Chunshui Yu, M.D.

373405810@qq.com

8618008256917

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin, 300120

Site Contact

Litao Zhang, M.D.

zhanglitao@medmail.com.cn

8618602228122

Kunming, Yunnan, China

Status

Recruiting

Address

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650118

Site Contact

Yunhui Yang, M.D.

danqid128@sina.com

8613888139863

Hangzhou Third People's Hospital, Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310002

Site Contact

Tianhong Xu, M.D.

1467314735@qq.com

8613282842619

Hangzhou First People's Hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006

Site Contact

Liming Wu, M.D.

18957118053@163.com

8613750837205

Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Status

Active, not recruiting

Address

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014

Hangzhou, Zhejiang, China

Status

Active, not recruiting

Address

Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016

The First Hospital of Jiaxing, Jiaxing, Zhejiang, China

Status

Recruiting

Address

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314001

Site Contact

Wenhao Yin, M.D.

whyin69@sina.com

8613957322306

Wenzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000

Site Contact

Zhiming Li, M.D.

wyyyll01@163.com

8615988718867

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