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
1 other identifier
interventional
261
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2024
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedStudy Start
First participant enrolled
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2025
CompletedFebruary 8, 2024
January 1, 2024
1.1 years
January 9, 2024
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Assessment of SpondyloArthritis International Society criteria (ASAS）40
32 weeks
Assessment of SpondyloArthritis International Society criteria (ASAS）20
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP)
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1
16 weeks and 32 weeks
- +5 more secondary outcomes
Study Arms (3)
Placebo（JS005）
EXPERIMENTALRecombinant humanized IL-17A Monoclonal Antibody（JS005）150mg
EXPERIMENTALRecombinant humanized IL-17A Monoclonal Antibody（JS005）300mg
EXPERIMENTALInterventions
Injection
Injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnant or lactating women.
- 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.).
- \. 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.
- \. 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.
- \. use of \>= 2 TNF-α inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Junshi Bioscience Co., Ltd.lead
- Sponsor GmbHcollaborator
Study Sites (38)
Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020, China
Jilin Province People's Hospital
Jilin, Changchun, 130021, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
Dongguan People's Hospital
Dongguan, Guangdong, 523018, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510180, China
Zhujiang Hospital of Southren Medical University
Guangzhou, Guangdong, 510280, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001, China
Jieyang People's Hospital
Jieyang, Guangdong, 522000, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Nanyang Central Hospital
Nanyang, Henan, 473003, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450001, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
The First Affiliated Hospital of Baotou Medical University
Baotou, Inner Mongolia, 014010, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010030, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221006, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
The First People's Hospital of Jiujiang City
Jiujiang, Jiangxi, 332000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Bethune First Hospital Of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830001, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huji Xu, PhD
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
February 8, 2024
Study Start
January 12, 2024
Primary Completion
February 26, 2025
Study Completion
October 8, 2025
Last Updated
February 8, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share