The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .
This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo. 1. JS005 150mg Cohort: JS005 150 mg or placebo treatment(JS005:Placrbo=3:1) s.c. prefilled syringe (PFS) on Week 0, 1, 2, 3, 4,8 and 12 2. JS005 300mg Cohort: JS005 300 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 3 .JS005 450mg Cohort: JS005 450 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria
at the end of treatment Week 16 .
Time frame: From week 0 to week 16
ASAS20 response criteria
The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16
Time frame: From week 0 to week 16
ASAS 5/6 response criteria
The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;
Time frame: From week 0 to week 16
High-sensitivity C-reactive protein (hsCRP)
The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16
Time frame: From week 0 to week 16
The inflammation score of the sacroiliac joint
The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16
Time frame: From week 0 to week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;
Time frame: From week 0 to week 16
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16
Time frame: From week 0 to week 16
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Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital of Nanfang Medical University
Guangzhou, Guangdong, China
RECRUITINGShantou University Medical Collge No.1 Affiliated Hospital
Shantou, Guangdong, China
NOT_YET_RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGPking University Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITING...and 15 more locations
Bath Ankylosing Spondylitis Functional Index (BASFI)
The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16
Time frame: From week 0 to week 16
Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)
The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16
Time frame: From week 0 to week 16
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16
Time frame: From week 0 to week 16
The patient's global assessment of disease activity
Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week?
Time frame: From week 0 to week 16
The patient's assessment of inflammatory back pain intensity
NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week.
Time frame: From week 0 to week 16
ASAS partial remission criteria
The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16
Time frame: From week 0 to week 16