A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
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
1 other identifier
interventional
510
1 country
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2023
CompletedFirst Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2025
CompletedMarch 18, 2026
March 1, 2026
1.2 years
March 1, 2024
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
the response rate of ASAS20
Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.
week 16
Secondary Outcomes (10)
The response rate of ASAS40
week 16
The response rate of ASAS20
baseline to week 52
The response rate of ASAS40
baseline to week 52
The response rate of ASAS5/6
baseline to week 52
Change from baseline on the ASDAS-CRP
baseline to week 52
- +5 more secondary outcomes
Study Arms (2)
AK111
EXPERIMENTALAK111 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 COMPARATORPlacebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Interventions
Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (54)
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
Liuchow, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
April 22, 2024
Study Start
November 22, 2023
Primary Completion
February 19, 2025
Study Completion
November 7, 2025
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share