This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).
Approximately 258 eligible subjects (129 per arm) will be randomized in a 1:1 ratio to Jaktinib 100mg BID (twice daily) or matching placebo BID for a total of 16 weeks of blinded treatment. During the 16-week treatment period subjects will visit the clinic every two weeks until the Week 4 visit and then every 4 weeks until the completion of Week 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
RenJi Hospital
Shanghai, Shanghai Municipality, China
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16
ASAS40 is defined as a \>= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.
Time frame: Week 16
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
ASAS20 is defined as a \>= 20% improvement and an absolute improvement of \>= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of \>= 20% and a net worsening of \>= 1 unit \[on a scale of 0 to 10\])
Time frame: Week 16
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12.
ASAS40 is defined as a \>= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.
Time frame: Week 2、4、8 and 12
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12.
ASAS20 is defined as a \>= 20% improvement and an absolute improvement of \>= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of \>= 20% and a net worsening of \>= 1 unit \[on a scale of 0 to 10\])
Time frame: Week 2、4、8 and 12
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