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
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baotou Central Hospital Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Inner Mongolia Baotou Steel Hospital Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tongren Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Ningbo Huamei Hospital, University of Chinese Academy of Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Luhe Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| Bethune first hospital of jilin university Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Xiangya Third Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Affiliated Hospital of Chengde Medical College Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chengdu Second People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Gannan Medical College Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Guangdong General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Run Run Shaw Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Hangzhou Third People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The First Hospital Of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Shandong Dermatology Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Unknown status |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Lianyungang First People's Hospital Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangxi Dermatology Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanyang city first People's Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Panjin Liao oil precious stone flower hospital Coordinator of this site? Confirm its status | Panjin | China | Unknown status |
| Shanghai Dermatology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| North East Central International Hospital Limited Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenyang Hospital of Integrated Chinese and Western Medicine Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shiyan City People's Hospital Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The Second Hospital of Shanxi Medical University City:Taiyuan Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan University People's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi Second People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The Second Affiliated Hospital of Xiamen Medical College Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Medicine School of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xian | China | Unknown status |
| Xingtai People's Hospital Coordinator of this site? Confirm its status | Xingtai | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical College Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Yancheng First People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Unknown status |
| Ningxia Medical University General Hospital Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.