The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with Active Ankylosing Spondylitis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat Ankylosing Spondylitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
113
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Proportion of patients achieving ASAS40
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16.
Time frame: Week 16
Proportion of patients achieving ASAS20
Proportion of patients achieving 20% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Proportion of patients achieving ASAS40
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 24, 36, and 52.
Time frame: at Week 2, 4, 8, 12, 24, 36, and 52
Proportion of patients achieving ASAS5/6
Proportion of patients achieving ASAS5/6 at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASDAI
Change from baseline in BASDAI at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Change from baseline in BASMI
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 2, 4, 8, 12, 16, 24, 36, and 52
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASFI
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 2, 4, 8, 12, 16, 24, 36, and 52.
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Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52