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NCT05975268CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
747 (actual)
First submitted
27 Jul 2023
Start date
28 Aug 2023
Primary completion date
20 Aug 2025
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Diseases
Psoriasis
NCT number
NCT05975268

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 747
  • From 28 Aug 2023 to the primary completion date, 20 Aug 2025
  • 63 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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

Other

  • Pregnant and lactating women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baotou Central Hospital
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BaotouChinaUnknown status
Inner Mongolia Baotou Steel Hospital
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BaotouChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Beijing Tongren Hospital affiliated to Capital Medical University
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
Beijing Luhe Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Tsinghua Changgung Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
Bethune first hospital of jilin university
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ChangchunChinaUnknown status
Xiangya Third Hospital, Central South University
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ChangshaChinaUnknown status
The Second Xiangya Hospital, Central South University
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ChangshaChinaUnknown status
The Affiliated Hospital of Chengde Medical College
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ChengdeChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chengdu Second People's Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The First Affiliated Hospital of Gannan Medical College
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GanzhouChinaUnknown status
Guangdong General Hospital
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GuangzhouChinaUnknown status
Guangzhou First People's Hospital
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GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Dermatology Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Run Run Shaw Hospital, Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Hangzhou Third People's Hospital
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HangzhouChinaUnknown status
Hangzhou First People's Hospital
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HangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
The Second Affiliated Hospital Of Anhui Medical University
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HefeiChinaUnknown status
The First Hospital Of Jiaxing
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JiaxingChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Shandong Dermatology Hospital
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JinanChinaUnknown status
Jingzhou Central Hospital
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JingzhouChinaUnknown status
The Second Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
Lianyungang First People's Hospital
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LianyungangChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Jiangxi Dermatology Hospital
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NanchangChinaUnknown status
Nanyang city first People's Hospital
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NanyangChinaUnknown status
Panjin Liao oil precious stone flower hospital
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PanjinChinaUnknown status
Shanghai Dermatology Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital affiliated to China Medical University
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ShenyangChinaUnknown status
North East Central International Hospital Limited
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ShenyangChinaUnknown status
Shenyang Hospital of Integrated Chinese and Western Medicine
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ShenyangChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
The First Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Shiyan City People's Hospital
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ShiyanChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
The Second Hospital of Shanxi Medical University City:Taiyuan
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TaiyuanChinaUnknown status
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Wuhan University People's Hospital
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WuhanChinaUnknown status
Wuxi Second People's Hospital
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WuxiChinaUnknown status
The Second Affiliated Hospital of Xiamen Medical College
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XiamenChinaUnknown status
The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian
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Xi’anChinaUnknown status
Medicine School of Xi'an Jiaotong University
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XianChinaUnknown status
Xingtai People's Hospital
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XingtaiChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical College
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XinxiangChinaUnknown status
Yancheng First People's Hospital
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YanchengChinaUnknown status
Ningxia Medical University General Hospital
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YinchuanChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.