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

Last updated: December 30, 2024
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Rash

Rosacea

Treatment

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

Clinical Study ID

NCT05975268
JS005-005-III-PsO
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily particpate in this clinical study and sign the informed consentform.

  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 contraceptivemethod during the study period and 20 weeks (expected 5 half-lives) after the laststudy drug administration and have a negative pregnancy test during the screeningperiod and prior to randomization.

Exclusion

Exclusion Criteria:

  1. Pregnant and lactating women.

  2. A history of inflammatory bowel disease or other conditions with a high risk ofperforation (e.g., severe gastrointestinal ulcers, etc.) or with other activeautoimmune 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 activeinflammatory skin disease other than psoriasis

  4. Use of phototherapy, including but not limited to ultraviolet A phototherapy (withor without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeksprior to randomization. Subjects are unwilling to avoid excessive sunlight exposurewithin 4 weeks prior to randomization and during the study period;

  5. A (current) history of systemic infection or serious infection requiringhospitalization and/or intravenous anti-infective therapy (e.g., antibiotics,antifungal agents, antiviral agents) within 12 weeks prior to randomization; ahistory of any active infection, other than common upper respiratory infections,within 2 weeks prior to randomization;

Study Design

Total Participants: 747
Treatment Group(s): 1
Primary Treatment: JS005 (recombinant humanized monoclonal antibody against IL-17A)
Phase: 3
Study Start date:
August 28, 2023
Estimated Completion Date:
October 29, 2025

Study 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).

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100044
    China

    Site Not Available

  • Beijing LuHe Hospital Capital Medical University

    Beijing, Beijing 101199
    China

    Site Not Available

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing, Beijing 100044
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102218
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences

    Beijing, Beijing 100864
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361023
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong 523018
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

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

    Guangzhou, Guangdong 518107
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei 054031
    China

    Site Not Available

  • Nanyang city first People's Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan 453100
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Site Not Available

  • Shiyan City People's Hospital

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Wuhan University People's Hospital

    Wuhan, Hubei 430060
    China

    Site Not Available

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Xiangya Third Hospital, Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu 222002
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215123
    China

    Site Not Available

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu 214002
    China

    Site Not Available

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224006
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • Jiangxi Dermatology Hospital

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Bethune First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Panjin Liao oil precious stone flower hospital

    Panjin, Liaoning 124011
    China

    Site Not Available

  • North East Central International Hospital Limited

    Shenyang, Liaoning
    China

    Site Not Available

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Shenyang Hospital of Integrated Chinese and Western Medicine

    Shenyang, Liaoning 110021
    China

    Site Not Available

  • Baotou Central Hospital

    Baotou, Neimenggu 014040
    China

    Site Not Available

  • Inner Mongolia Baotou Steel Hospital

    Baotou, Neimengu 010000
    China

    Site Not Available

  • Ningxia Medical University General Hospital

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shandong Dermatology Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai 200050
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University City:Taiyuan

    Taiyuan, Shanxi 030001
    China

    Site Not Available

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

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Medicine School of Xi'an Jiaotong University

    Xian, Shanxi 710004
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610017
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Suining Central Hospital

    Suining, Sichuan 629000
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin 300120
    China

    Site Not Available

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650118
    China

    Site Not Available

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang 310002
    China

    Site Not Available

  • Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang 314001
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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