Clinical trial NCT06250062: A Clinical Study of JS005 in Patients With Ankylosing Spondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2024-02-08
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

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.


Eligibility criteria: 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-α inhibitors.

Primary outcomes:
measure: Assessment of SpondyloArthritis International Society criteria (ASAS）40
timeFrame: 16 weeks
Secondary outcomes:
measure: Assessment of SpondyloArthritis International Society criteria (ASAS）40
timeFrame: 32 weeks
measure: Assessment of SpondyloArthritis International Society criteria (ASAS）20
timeFrame: 16 weeks and 32 weeks
measure: Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP)
timeFrame: 16 weeks and 32 weeks
measure: Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1
timeFrame: 16 weeks and 32 weeks
measure: Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1
timeFrame: 16 weeks and 32 weeks
measure: Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0
timeFrame: 16 weeks and 32 weeks
measure: Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3
timeFrame: 16 weeks and 32 weeks
measure: Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission
timeFrame: 16 weeks and 32 weeks
measure: Pharmacokinetic(PK)
timeFrame: 40 weeks
measure: Immunogenicity
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital,Capital Medical University
state: Beijing
city: Jilin
country: China
facility: Jilin Province People's Hospital
state: Changchun
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southren Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical University
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Jiujiang
country: China
facility: The First People's Hospital of Jiujiang City
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Bethune First Hospital Of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
state: Xinjiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Huji Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: