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 Ankylosing Spondylitis. Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese AS patients in terms of ASAS 20 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 AS from Week 16 on.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
131
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).
Anhui Provincial Hospital
Hefei, Anhui, China
Primary efficacy endpoint
The proportion of AS patients meeting the Assessment of Spondylo Arthritis international Society 20 (ASAS20) response criteria at the end of treatment Week 16.
Time frame: From week 0 to week 16
ASAS40 response criteria
The proportion of patients meeting the ASAS40 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
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
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
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
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Beijing University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Shamen, Fujian, China
Sun Yat-sen Memorial Sun Yat-sen University City: Guangzhou
Guangzhou, Guangdong, China
Nanfang Hospital of Nandang Medical University
Guangzhou, Guangdong, China
Shantou University Medical Collge No.1 Affiliated Hospital
Shantou, Guangdong, China
Pking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Gudong, China
Tianjin Medical University General Hospital
Tianjin, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
...and 13 more locations
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
The proportion of patients meeting the ASAS partial remission criteria
The proportion of patients meeting the ASAS partial remission criteria at the end of treatment Week 16
Time frame: From week 0 to week 16
nkylosing 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
The patient's global assessment of disease activity
The change from baseline in the patient's global assessment of disease activity at the end of treatment Week 16
Time frame: From week 0 to week 16
The patient's assessment of inflammatory back pain intensity
The change from baseline in the patient's assessment of inflammatory back pain intensity at the end of treatment Week 16
Time frame: From week 0 to week 16