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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06378697
Other study ID # AK111-303
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 10, 2023
Est. completion date April 30, 2026

Study information

Verified date April 2024
Source Akeso
Contact Guoqin Wang
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study consists of 3 parts. Part 1 is screening period, Part 2 is Placebo control period and part 3 is Long term treatment follow-up period. The research period is 61 weeks in total.


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date April 30, 2026
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 a (TNF-a) 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
China 1034-Affiliated Hospital of Hebei University Baoding Hebei
China 1001-Peking University Third Hospital Beijing Beijing
China 1002-Xuanwu Hospital Capital Medical University Beijing Beijing
China 1042-Peking University Shougang Hospital Beijing Beijing
China 1006-The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
China 1044-Jilin Provincial People's Hospital Changchun Jilin
China 1017-Changzhou NO.2 People's Hospital Changzhou Jiangsu
China 1010-West China Hospital,Sichuan University Chengdu Sichuan
China 1047-The First Affiliated Hospital of Gannan Medical College Ganzhou Jiangxi
China 1005-Nanfang Hospital Guangzhou Guangdong
China 1025-Guangzhou First People's Hospital Guangzhou Guangdong
China 1022-The First Affiliated Hospital of Hainan Medical University Haikou Hainan
China 1038-Anhui Provincial Hospital Hefei Anhui
China 1031-The First Affiliated Hospital of University of South China Hengyang Hunan
China 1040- Huzhou Third People's Hospital Huzhou Zhejiang
China 1030-Jieyang People's Hospital Jieyang Guangdong
China 1028- Jining First People's Hospital Jining Shandong
China 1012-Hebei Petro China Central Hospital Langfang Hebei
China 1027-Lanzhou University Second Hospital Lanzhou Gansu
China 1037-The Second People's Hospital of Lianyungang Lianyungang Jiangsu
China 1054-Linfen Central Hospital Linfen Shanxi
China 1019-Linyi City People Hospital Linyi Shandong
China 1024-Liuzhou People's Hospital Liuzhou Guangxi
China 1045-The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
China 1048-Mianyang Central Hospital Mianyang Sichuan
China 1020-The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China 1039-The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China 1041-Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan
China 1004-Zhongda Hospital Southeast University Nanjing Jiangsu
China 1007-Nanjing Drum Tower Hospital Nanjing Jiangsu
China 1036-Jiangsu Province Hospital Nanjing Jiangsu
China 1021-The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
China 1018-Affiliated Hospital of Nantong University Nantong Jiangsu
China 1053-Nanyang Central Hospital Nanyang Henan
China 1046-Pingxiang People's Hospital Pingxiang Jiangxi
China 1033-The First Hospital of Qiqihar Qiqihar Heilongjiang
China 1008-The Seventh Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong
China 1026-Shenzhen People's Hospital Shenzhen Guangdong
China 1029-Hebei General Hospital Shijiazhuang Hebei
China 1051-Shiyan People's Hospital Shiyan Hubei
China 1009-Second Hospital of Shanxi Medical University Taiyuan Shanxi
China 1015-Taizhou Hospital of Zhejiang Province Taizhou Zhejiang
China 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region Urumqi Xinjiang
China 1055-Weifang People's Hospital Weifang Shandong
China 1050-The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China 1035-Wuxi People's Hospital Wuxi Jiangsu
China 1049-The First Affiliated Hospital of Xiamen University Xiamen Fujian
China 1013-Xuzhou Central Hospital Xuzhou Jiangsu
China 1032-Yueyang Central Hospital Yueyang Hunan
China 1043-Yuncheng Central Hospital Yuncheng Shanxi
China 1016-Zaozhuang Municipal Hospital Zaozhuang Shandong
China 1014-Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
China 1056-Zhongshan Traditional Chinese Medicine Hospital Zhongshan Guangdong
China 1011-Zhuzhou Central Hospital Zhuzhou Hunan

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The response rate of ASAS40 Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16. week 16
Secondary The response rate of ASAS20 Percentage of subjects who achieve ASAS20 response throughout the clinical trial baseline to week 52
Secondary The response rate of ASAS40 Percentage of subjects who achieve ASAS40 response throughout the clinical trial baseline to week 52
Secondary The response rate of ASAS5/6 Percentage of subjects who achieve =20% improvement in five of the six domains (ASAS5/6) response throughout the clinical trial baseline to week 52
Secondary Change from baseline on the ASDAS-CRP Change from baseline on the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) at each visit from baseline baseline to week 52
Secondary Change from baseline on the SF-36 PCS Change from baseline on the Short-Form 36 physical component score(SF-36 PCS) at each visit from baseline baseline, week 16 and week 52
Secondary Change from baseline on the ASQoL scores Change from baseline on the Ankylosing Spondylitis Quality of Life (ASQoL) scores at each visit from baseline baseline, week 16 and week 52
Secondary Treatment-emergent adverse events Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study baseline to week 52
Secondary Serious adverse events Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study baseline to week 52
Secondary Clinically significant examination results Recording clinically significant examination results baseline to week 52
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