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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
Injection
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.
Time frame: 16 weeks
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.
Time frame: 32 weeks
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.
Time frame: 16 weeks and 32 weeks
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
Time frame: 16 weeks and 32 weeks
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.
Time frame: 16 weeks and 32 weeks
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.
Time frame: 16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0
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Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Jilin Province People's Hospital
Jilin City, Changchun, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southren Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
...and 28 more locations
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.
Time frame: 16 weeks and 32 weeks
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
Time frame: 16 weeks and 32 weeks
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
Time frame: 16 weeks and 32 weeks
Pharmacokinetic(PK)
To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005
Time frame: 40 weeks
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
Time frame: 40 weeks