To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
159
Administered Brodalumab by subcutaneous (SC) injection until week 66.
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Percentage of ASAS 40 in axSpA subjects
Time frame: Week 16
Percentage of ASAS 40 in AS subjects
Time frame: Week 16
Percentage of ASAS 40 in nr-axSpA subjects
Time frame: Week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
Time frame: Week 16
Number of adverse events
Time frame: Up to week 68
Number of patients exposed to anti-KHK4827 antibodies
Time frame: Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
Serum KHK4827 concentration
Time frame: pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32
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