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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378697
• Other study ID #: AK111-303
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

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