This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
SHR0302, oral, once daily
SHR0302 placebo, oral, once daily
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
Time frame: Week 12
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12
Time frame: Week 12
Percentage of Participants With ASAS 20 Response at week 12
Time frame: Week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12
Time frame: Week 12
Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24
Time frame: Week 12 and Week 24
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