nctId: NCT06378697 id: AK111-303 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis overallStatus: RECRUITING date: 2023-11-10 date: 2025-02-28 date: 2026-04-30 date: 2024-04-22 date: 2024-04-22 name: Akeso class: INDUSTRY briefSummary: 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. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: AK111 name: Placebo+AK111 measure: the response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS5/6 measure: Change from baseline on the ASDAS-CRP measure: Change from baseline on the SF-36 PCS measure: Change from baseline on the ASQoL scores measure: Treatment-emergent adverse events measure: Serious adverse events measure: Clinically significant examination results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1006-The First Affiliated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui country: China lat: 32.94083 lon: 117.36083 facility: 1038-Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: 1001-Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1002-Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1042-Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1049-The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: 1027-Lanzhou University Second Hospital status: RECRUITING city: Lanzhou state: Gansu country: China lat: 36.05701 lon: 103.83987 facility: 1005-Nanfang Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1025-Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1030-Jieyang People's Hospital status: RECRUITING city: Jieyang state: Guangdong country: China lat: 23.5418 lon: 116.36581 facility: 1008-The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1026-Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1056-Zhongshan Traditional Chinese Medicine Hospital status: RECRUITING city: Zhongshan state: Guangdong country: China lat: 21.31992 lon: 110.5723 facility: 1024-Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: 1021-The People's Hospital of Guangxi Zhuang Autonomous Region status: RECRUITING city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 facility: 1022-The First Affiliated Hospital of Hainan Medical University status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: 1034-Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei country: China lat: 38.85111 lon: 115.49028 facility: 1012-Hebei Petro China Central Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: 1029-Hebei General Hospital status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: 1033-The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: 1045-The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: 1053-Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: 1051-Shiyan People's Hospital status: RECRUITING city: Shiyan state: Hubei country: China lat: 32.6475 lon: 110.77806 facility: 1031-The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: 1032-Yueyang Central Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: 1011-Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan country: China lat: 27.83333 lon: 113.15 facility: 1017-Changzhou NO.2 People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: 1037-The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: 1004-Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1007-Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1036-Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1018-Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu country: China lat: 32.03028 lon: 120.87472 facility: 1035-Wuxi People's Hospital status: RECRUITING city: Wuxi state: Jiangsu country: China lat: 31.56887 lon: 120.28857 facility: 1013-Xuzhou Central Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: 1014-Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: 1047-The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: 1020-The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1039-The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1046-Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: 1044-Jilin Provincial People's Hospital status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: 1028- Jining First People's Hospital status: RECRUITING city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: 1019-Linyi City People Hospital status: RECRUITING city: Linyi state: Shandong country: China lat: 35.06306 lon: 118.34278 facility: 1055-Weifang People's Hospital status: RECRUITING city: Weifang state: Shandong country: China lat: 36.71 lon: 119.10194 facility: 1016-Zaozhuang Municipal Hospital status: RECRUITING city: Zaozhuang state: Shandong country: China lat: 34.86472 lon: 117.55417 facility: 1054-Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China lat: 36.08889 lon: 111.51889 facility: 1009-Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi country: China lat: 37.86944 lon: 112.56028 facility: 1043-Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: 1010-West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: 1048-Mianyang Central Hospital status: RECRUITING city: Mianyang state: Sichuan country: China lat: 31.46784 lon: 104.68168 facility: 1041-Affiliated Hospital of North Sichuan Medical College status: RECRUITING city: Nanchong state: Sichuan country: China lat: 30.79508 lon: 106.08473 facility: 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: 1040- Huzhou Third People's Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 facility: 1015-Taizhou Hospital of Zhejiang Province status: RECRUITING city: Taizhou state: Zhejiang country: China lat: 32.49069 lon: 119.90812 facility: 1050-The First Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False