This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.
The study consists of 3 parts. Part 1 is screening period, Part 2 is Placebo control period and part 3 is Long term treatment follow-up period. The research period is 61 weeks in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.
Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
the response rate of ASAS20
Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.
Time frame: week 16
The response rate of ASAS40
Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16.
Time frame: week 16
The response rate of ASAS20
Percentage of subjects who achieve ASAS20 response throughout the clinical trial
Time frame: baseline to week 52
The response rate of ASAS40
Percentage of subjects who achieve ASAS40 response throughout the clinical trial
Time frame: baseline to week 52
The response rate of ASAS5/6
Percentage of subjects who achieve ≥20% improvement in five of the six domains (ASAS5/6) response throughout the clinical trial
Time frame: baseline to week 52
Change from baseline on the ASDAS-CRP
Change from baseline on the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) at each visit from baseline
Time frame: baseline to week 52
Change from baseline on the SF-36 PCS
Change from baseline on the Short-Form 36 physical component score(SF-36 PCS) at each visit from baseline
Time frame: baseline, week 16 and week 52
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1006-The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
1038-Anhui Provincial Hospital
Hefei, Anhui, China
1001-Peking University Third Hospital
Beijing, Beijing Municipality, China
1002-Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
1042-Peking University Shougang Hospital
Beijing, Beijing Municipality, China
1049-The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
1027-Lanzhou University Second Hospital
Lanzhou, Gansu, China
1005-Nanfang Hospital
Guangzhou, Guangdong, China
1025-Guangzhou First People's Hospital
Guangzhou, Guangdong, China
1030-Jieyang People's Hospital
Jieyang, Guangdong, China
...and 44 more locations
Change from baseline on the ASQoL scores
Change from baseline on the Ankylosing Spondylitis Quality of Life (ASQoL) scores at each visit from baseline
Time frame: baseline, week 16 and week 52
Treatment-emergent adverse events
Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study
Time frame: baseline to week 52
Serious adverse events
Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study
Time frame: baseline to week 52
Clinically significant examination results
Recording clinically significant examination results
Time frame: baseline to week 52