NCT06250062CompletedPhase 2
A Clinical Study of JS005 in Patients With Ankylosing Spondylitis
A Phase II, Randomized, Double-blind, Placebo-controlled , Multicenter Study to Evaluate the Preliminary Efficacy and Safety of Subcutaneous Injection of Recombinant Humanized Anti-IL-17A Monoclonal Antibody(JS005) in Adult Patients With Active Ankylosing Spondylitis
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 265 (actual)
- First submitted
- 9 Jan 2024
- Start date
- Jan 2024
- Primary completion date
- Jan 2024
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06250062
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 265
- From Jan 2024 to the primary completion date, Jan 2024
- 38 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
- Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).
- 4\. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
- 6\. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.
- 9\. use of \>= 2 TNF-α inhibitors.
Other
- Pregnant or 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)
- Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984 4. Diagnosis of active AS (active AS is defined as: BASDAI \>= 4, total back pain score \>=4, and BASDAI second question spinal pain score \>=4)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Baotou Medical University Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Binzhou Medical University Hospital Coordinator of this site? Confirm its status | Binzhou | China | Unknown status |
| Bethune first hospital of jilin university Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| First Affiliated Hospital Of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhujiang Hospital of Southren Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Huizhou Central People's Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jieyang People's Hospital Coordinator of this site? Confirm its status | Jieyang | China | Unknown status |
| Jilin Province People's Hospital Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First People's Hospital of Jiujiang City Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| Gansu Provincial Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| the First Affiliated Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen Second People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Xinjiang Uygur Autonomous Region People's Hospital Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Zaozhuang Municipal Hospital Coordinator of this site? Confirm its status | Zaozhuang | China | Unknown status |
| Zhengzhou Central Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Zhuzhou Central Hospital Coordinator of this site? Confirm its status | Zhuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.