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NCT06378697

PHASE3

A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Active Ankylosing Spondylitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2023-11-22

Completion Date

2025-11-07

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Ankylosing Spondylitis

Interventions

DRUG

AK111

Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.

DRUG

Placebo+AK111

Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.

Inclusion Criteria: * Male or female subjects aged ≥18 years old. * Subjects with confirmed ankylosing spondylitis before screening. * During screening and before randomization, BASDAI score ≥ 4, total back pain score≥ 4. * Subjects received at least 2 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond, or with contraindications or intolerance to the use of NSAIDs. * Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids(The daily dose should be ≤10mg prednisone or equivalent dose of glucocorticoid) as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization. If the drug has been discontinued, at least 2 weeks washout period is required before randomization. * Subjects taking methotrexate (MTX) (≤25mg/week) or Sulfasalazine (≤3g/day) are allowed to continue their medication if started at least 12 weeks prior to baseline, with a stable dose for at least 4 weeks before randomization. If the drug has been discontinued, at least 4 weeks washout period is required before randomization. * Subjects who are able to understand and voluntarily sign the ICF and complete the study procedure. Exclusion Criteria: * Subjects with symptom of pain that affected the evaluation of efficacy. * Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS). * Subjects who are using strong opioid analgesics. * Received glucocorticoid intramuscular or intravenous injection within 2 weeks prior to randomization; Received intraarticular or paraspinal glucocorticoid therapy within 4 weeks before randomization. * Received other antirheumatic drugs (except methotrexate, sulfasalazine), proprietary Chinese medicine or traditional Chinese medicine decoction, JAK inhibitor treatment for AS within 4 weeks before randomization. * Received Natalizumab or other B cell or T cell modulator in the 12 months prior to randomization. * Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. * Received multiple tumor necrosis factor α (TNF-α) inhibitors; The eluting period of biologics received before randomization is shorter than the protocol. * Participated in a clinical study of any other drug or medical device within 1 month (≤30 days) prior to randomization, or last received the investigational drug within 5 half-lives. * The presence of any other systemic disease or laboratory abnormalities that the investigator has judged unsuitable for clinical trials.

Locations (60)

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

1061-Beijing Tiantan 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

1060-The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

1024-Liuzhou People's Hospital

Liuzhou, Guangxi, China

1021-The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

1057-The Second Affiliated Hospital of Guangxi Medical University

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

1058-Affiliated Hospital of Jining Medical University

Jining, Shandong, China

1019-Linyi City People Hospital

Linyi, Shandong, China

1062-Qilu Hospital (Qingdao), Shandong University

Qingdao, 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

1059-Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 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

Clinical Research Directory

A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)