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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.
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

Full criteria on ClinicalTrials.gov

Sites (38)

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

SiteCityCountrySite status
The First Affiliated Hospital of Baotou Medical University
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BaotouChinaUnknown status
Beijing Chao-Yang Hospital, Capital Medical University
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BeijingChinaUnknown status
Binzhou Medical University Hospital
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BinzhouChinaUnknown status
Bethune first hospital of jilin university
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ChangchunChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
The Third Affiliated Hospital of Sun Yat-Sen University
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GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital
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GuangzhouChinaUnknown status
Zhujiang Hospital of Southren Medical University
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GuangzhouChinaUnknown status
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaUnknown status
Huizhou Central People's Hospital
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HuizhouChinaUnknown status
Jieyang People's Hospital
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JieyangChinaUnknown status
Jilin Province People's Hospital
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Jilin CityChinaUnknown status
Shandong Provincial Hospital
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JinanChinaUnknown status
The First People's Hospital of Jiujiang City
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JiujiangChinaUnknown status
Gansu Provincial Hospital
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LanzhouChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Nanyang Central Hospital
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NanyangChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
the First Affiliated Hospital of Shantou University Medical College
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ShantouChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
Shenzhen Second People's Hospital
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ShenzhenChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
Second hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Xinjiang Uygur Autonomous Region People's Hospital
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ÜrümqiChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Zhongshan Hospital Xiamen University
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XiamenChinaUnknown status
Xuzhou Central Hospital
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XuzhouChinaUnknown status
Zaozhuang Municipal Hospital
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ZaozhuangChinaUnknown status
Zhengzhou Central Hospital
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ZhengzhouChinaUnknown status
Zhuzhou Central Hospital
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ZhuzhouChinaUnknown status

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