A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
NCT ID: NCT06378697
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2023-11-10
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK111
AK111 150 mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week 48.
AK111
Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.
placebo
Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Placebo+AK111
Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Interventions
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AK111
Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.
Placebo+AK111
Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Other Identifiers
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AK111-303
Identifier Type: -
Identifier Source: org_study_id
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