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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250062
Other study ID # JS005-006-?-AS
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 12, 2024
Est. completion date October 8, 2025

Study information

Verified date January 2024
Source Shanghai Junshi Bioscience Co., Ltd.
Contact Jiexin Hu
Phone 13521183167
Email jiexin_hu@junshipharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 261
Est. completion date October 8, 2025
Est. primary completion date February 26, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subjects voluntarily particpate in this clinical study and sign the informed consent form. 2. Male and female patients aged 18-75 years at the time of screening (both inclusive) 3. 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) Exclusion Criteria: 1. Pregnant or lactating women. 2. 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-a inhibitors.

Study Design


Intervention

Drug:
Recombinant humanized IL-17A Monoclonal Antibody(JS005)
Injection
Placebo(JS005)
Injection

Locations

Country Name City State
China The First Affiliated Hospital of Baotou Medical University Baotou Inner Mongolia
China Beijing Chao-yang Hospital,Capital Medical University Beijing Beijing
China Binzhou Medical University Hospital Binzhou Shandong
China Bethune First Hospital Of Jilin University Changchun Jilin
China West China Hospital of Sichuan University Chengdu Sichuan
China Dongguan People's Hospital Dongguan Guangdong
China First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital Guangzhou Guangdong
China The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China Zhujiang Hospital of Southren Medical University Guangzhou Guangdong
China The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
China Huizhou Central People's Hospital Huizhou Guangdong
China Jieyang People's Hospital Jieyang Guangdong
China Jilin Province People's Hospital Jilin Changchun
China Shandong Provincial Hospital Jinan Shandong
China The First People's Hospital of Jiujiang City Jiujiang Jiangxi
China Gansu Provincial Hospital Lanzhou Gansu
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Nanjing Drum Tower Hospital Nanjing Jiangsu
China Nanyang Central Hospital Nanyang Henan
China Pingxiang People's Hospital Pingxiang Jiangxi
China Shanghai Changzheng Hospital Shanghai Shanghai
China The First Affiliated Hospital of Shantou University Medical College Shantou Guangdong
China The First Hospital of China Medical University Shenyang Liaoning
China Shenzhen People's Hospital Shenzhen Guangdong
China Shenzhen Second People's Hospital Shenzhen Guangdong
China Second Hospital of Shanxi Medical University Taiyuan Shanxi
China Xinjiang Uygur Autonomous Region People's Hospital Ürümqi Xinjiang
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
China Zhongshan Hospital Xiamen University Xiamen Fujian
China Xuzhou Central Hospital Xuzhou Jiangsu
China Zaozhuang Municipal Hospital Zaozhuang Shandong
China Zhengzhou Central Hospital Zhengzhou Henan
China Zhuzhou Central Hospital Zhuzhou Hunan

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Junshi Bioscience Co., Ltd. Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of SpondyloArthritis International Society criteria (ASAS)40 Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 16. 16 weeks
Secondary Assessment of SpondyloArthritis International Society criteria (ASAS)40 Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 32. 32 weeks
Secondary Assessment of SpondyloArthritis International Society criteria (ASAS)20 Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)20 response criteria at weeks 16 and 32. 16 weeks and 32 weeks
Secondary Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) Changes in ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) from baseline at weeks 16 and 32 16 weeks and 32 weeks
Secondary Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1 Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32. 16 weeks and 32 weeks
Secondary Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) = 1.1 The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 1.1 or greater from baselinat weeks 16 and 32. 16 weeks and 32 weeks
Secondary Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) = 2.0 The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 2.0 or greater from baselinat weeks 16 and 32. 16 weeks and 32 weeks
Secondary Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3 Proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) less than 1.3 at weeks 16 and 32 16 weeks and 32 weeks
Secondary Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission Proportion of subjects who achieved partial remission of Assessment of SpondyloArthritis International Society criteria (ASAS) at weeks 16 and 32 16 weeks and 32 weeks
Secondary Pharmacokinetic(PK) To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005 40 weeks
Secondary Immunogenicity The immunogenicity of JS005 was assessed by the positive incidence and titer of drug-resistant antibodies (ADA) and the incidence of neutralizing antibodies (NAb), if applicable 40 weeks
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