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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK111 | Experimental | AK111 150 mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week 48. |
|
| placebo | Placebo Comparator | Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK111 | Drug | Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the response rate of ASAS20 | Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16. | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate of ASAS40 | Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16. | week 16 |
| The response rate of ASAS20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1006-The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | China | |||
| 1038-Anhui Provincial Hospital |
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| Placebo+AK111 | Drug | Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48. |
|
Percentage of subjects who achieve ASAS20 response throughout the clinical trial
| baseline to week 52 |
| The response rate of ASAS40 | Percentage of subjects who achieve ASAS40 response throughout the clinical trial | 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 | 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 | 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 | baseline, week 16 and week 52 |
| Change from baseline on the ASQoL scores | Change from baseline on the Ankylosing Spondylitis Quality of Life (ASQoL) scores at each visit from baseline | baseline, week 16 and week 52 |
| Treatment-emergent adverse events | Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study | baseline to week 52 |
| Serious adverse events | Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study | baseline to week 52 |
| Clinically significant examination results | Recording clinically significant examination results | baseline to week 52 |
| 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 |
| 1008-The Seventh Affiliated Hospital, Sun Yat-sen University | Shenzhen | Guangdong | China |
| 1026-Shenzhen People's Hospital | Shenzhen | Guangdong | China |
| 1056-Zhongshan Traditional Chinese Medicine Hospital | Zhongshan | Guangdong | China |
| 1024-Liuzhou People's Hospital | Liuzhou | Guangxi | China |
| 1021-The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China |
| 1022-The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
| 1034-Affiliated Hospital of Hebei University | Baoding | Hebei | China |
| 1012-Hebei Petro China Central Hospital | Langfang | Hebei | China |
| 1029-Hebei General Hospital | Shijiazhuang | Hebei | China |
| 1033-The First Hospital of Qiqihar | Qiqihar | Heilongjiang | China |
| 1045-The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | China |
| 1053-Nanyang Central Hospital | Nanyang | Henan | China |
| 1051-Shiyan People's Hospital | Shiyan | Hubei | China |
| 1031-The First Affiliated Hospital of University of South China | Hengyang | Hunan | China |
| 1032-Yueyang Central Hospital | Yueyang | Hunan | China |
| 1011-Zhuzhou Central Hospital | Zhuzhou | Hunan | China |
| 1017-Changzhou NO.2 People's Hospital | Changzhou | Jiangsu | China |
| 1037-The Second People's Hospital of Lianyungang | Lianyungang | Jiangsu | China |
| 1004-Zhongda Hospital Southeast University | Nanjing | Jiangsu | China |
| 1007-Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| 1036-Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| 1018-Affiliated Hospital of Nantong University | Nantong | Jiangsu | China |
| 1035-Wuxi People's Hospital | Wuxi | Jiangsu | China |
| 1013-Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
| 1014-Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| 1047-The First Affiliated Hospital of Gannan Medical College | Ganzhou | Jiangxi | China |
| 1020-The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| 1039-The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| 1046-Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| 1044-Jilin Provincial People's Hospital | Changchun | Jilin | China |
| 1028- Jining First People's Hospital | Jining | Shandong | China |
| 1019-Linyi City People Hospital | Linyi | Shandong | China |
| 1055-Weifang People's Hospital | Weifang | Shandong | China |
| 1016-Zaozhuang Municipal Hospital | Zaozhuang | Shandong | China |
| 1054-Linfen Central Hospital | Linfen | Shanxi | China |
| 1009-Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| 1043-Yuncheng Central Hospital | Yuncheng | Shanxi | China |
| 1010-West China Hospital,Sichuan University | Chengdu | Sichuan | China |
| 1048-Mianyang Central Hospital | Mianyang | Sichuan | China |
| 1041-Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | China |
| 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region | Ürümqi | Xinjiang | China |
| 1040- Huzhou Third People's Hospital | Huzhou | Zhejiang | China |
| 1015-Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | China |
| 1050-The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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