A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
- Registration Number
- NCT06378697
- Lead Sponsor
- Akeso
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 510
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK111 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. placebo Placebo+AK111 Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
- Primary Outcome Measures
Name Time Method the response rate of ASAS20 week 16 Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.
- Secondary Outcome Measures
Name Time Method The response rate of ASAS20 baseline to week 52 Percentage of subjects who achieve ASAS20 response throughout the clinical trial
Change from baseline on the SF-36 PCS baseline, week 16 and week 52 Change from baseline on the Short-Form 36 physical component score(SF-36 PCS) at each visit from baseline
The response rate of ASAS40 baseline to week 52 Percentage of subjects who achieve ASAS40 response throughout the clinical trial
Change from baseline on the ASDAS-CRP baseline to week 52 Change from baseline on the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) at each visit from baseline
Change from baseline on the ASQoL scores baseline, week 16 and week 52 Change from baseline on the Ankylosing Spondylitis Quality of Life (ASQoL) scores at each visit from baseline
Treatment-emergent adverse events baseline to week 52 Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study
Serious adverse events baseline to week 52 Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study
Clinically significant examination results baseline to week 52 Recording clinically significant examination results
The response rate of ASAS5/6 baseline to week 52 Percentage of subjects who achieve ≥20% improvement in five of the six domains (ASAS5/6) response throughout the clinical trial
Trial Locations
- Locations (54)
1027-Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
1005-Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
1030-Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
1008-The Seventh Affiliated Hospital, Sun Yat-sen University
🇨🇳Shenzhen, Guangdong, China
1024-Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
1021-The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, 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
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
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
1028- Jining First People's Hospital
🇨🇳Jining, Shandong, China
1009-Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
1010-West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
1026-Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
1056-Zhongshan Traditional Chinese Medicine Hospital
🇨🇳Zhongshan, Guangdong, China
1025-Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
1001-Peking University Third Hospital
🇨🇳Beijing, Beijing, China
1002-Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
1031-The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
1036-Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
1004-Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
1007-Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
1039-The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
1043-Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China
1006-The First Affiliated Hospital of Bengbu Medical University
🇨🇳Bengbu, Anhui, China
1038-Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
1049-The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
1042-Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
1022-The First Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
1053-Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
1051-Shiyan People's Hospital
🇨🇳Shiyan, Hubei, China
1032-Yueyang Central Hospital
🇨🇳Yueyang, Hunan, China
1018-Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
1044-Jilin Provincial People's Hospital
🇨🇳Changchun, Jilin, China
1046-Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, 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
1048-Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
1023-The People's Hospital of Xinjiang Uyghur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
1041-Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
1040- Huzhou Third People's Hospital
🇨🇳Huzhou, Zhejiang, China
1050-The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
1015-Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China