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