{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T16:52:48Z","timestamp":1782492768564,"version":"3.54.5"},"reference-count":33,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T00:00:00Z","timestamp":1773100800000},"content-version":"unspecified","delay-in-days":9,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Suzhou Suncadia Biopharmaceutical Co., Ltd"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,25]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Hand osteoarthritis (OA) is a prevalent and debilitating joint disorder that impairs daily functioning and quality of life. Current treatments are often inadequate in managing the symptoms and progression of the disease. The cytokine interleukin (IL)-17 has been implicated in the inflammatory processes associated with OA, making it a potential target for therapeutic intervention. This trial aims to evaluate the efficacy of vunakizumab, an IL-17A inhibitor, in reducing pain and improving functional outcomes in patients with erosive hand OA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre, randomised, placebo-controlled, double-blind trial will enrol 150 participants aged 30\u201380 years with symptomatic erosive hand OA. Participants will be randomised in a 1:1 ratio to receive either vunakizumab 120\u2009mg or placebo subcutaneously every 4\u2009weeks for 24 weeks, with a loading dose injection period during the first 4\u2009weeks. The primary outcome is the change in hand pain assessed by the Visual Analogue Scale at 28 weeks. Secondary outcomes include changes in physical function measured by the Functional Index for Hand Osteoarthritis, the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and the Health Assessment Questionnaire, as well as changes in grip strength and radiographic and MRI evaluations of the hands.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Written informed consent will be obtained from all participants. The study was approved by the Ethics Committee of Shanghai Sixth People\u2019s Hospital (2024\u2013217)\u2009and will adhere to the Declaration of Helsinki. Research results will be published in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ChiCTR2500101031;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.chictr.org.cn\/showproj.html?proj=264789\">https:\/\/www.chictr.org.cn\/showproj.html?proj=264789<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-109072","type":"journal-article","created":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T14:55:50Z","timestamp":1773154550000},"page":"e109072","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): protocol for a multicentre, randomised controlled trial"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8721-0734","authenticated-orcid":false,"given":"Kai","family":"Fu","sequence":"first","affiliation":[{"name":"Department of Orthopedic Surgery, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirley P","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia"},{"name":"Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Bracken","sequence":"additional","affiliation":[{"name":"Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changhai","family":"Ding","sequence":"additional","affiliation":[{"name":"Clinical Research Centre, Zhujiang Hospital of Southern Medical University, Guangzhou, China"},{"name":"Institute of Exercise and Rehabilitation Science, Zhujiang Hospital of Southern Medical University, Guangzhou, China"},{"name":"Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia"},{"name":"Clinical Research Centre, Beijing Tsinghua Changgung Hospital, Tsinghua Medicine, Tsinghua University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifang","family":"Mei","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, The Second Affiliated Hospital, School of Medicine, Southern University of Science and Technology, Shenzhen, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Wei","sequence":"additional","affiliation":[{"name":"Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China"},{"name":"Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China"},{"name":"Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2987-138X","authenticated-orcid":false,"given":"Guanghua","family":"Lei","sequence":"additional","affiliation":[{"name":"Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China"},{"name":"Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China"},{"name":"Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaodong","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-6819-7212","authenticated-orcid":false,"given":"Yanping","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, First Affiliated Hospital of Harbin Medical University, Harbin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinshan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China"},{"name":"Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongqiang","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China"},{"name":"Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2672-4544","authenticated-orcid":false,"given":"Dongxing","family":"Xie","sequence":"additional","affiliation":[{"name":"Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China"},{"name":"Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China"},{"name":"Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ligang","family":"Jie","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weizhong","family":"Qi","sequence":"additional","affiliation":[{"name":"Clinical Research Centre, Zhujiang Hospital of Southern Medical University, Guangzhou, China"},{"name":"Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkatesha","family":"Venkatesha","sequence":"additional","affiliation":[{"name":"Northern Sydney Local Health District Executive, Royal North Shore Hospital, St Leonards, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenzhong","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianyou","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changqing","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3197-752X","authenticated-orcid":false,"given":"David J","family":"Hunter","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia"},{"name":"Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,3,10]]},"reference":[{"key":"2026062609355654000_16.3.e109072.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)30417-9"},{"key":"2026062609355654000_16.3.e109072.2","doi-asserted-by":"publisher","DOI":"10.1016\/S2665-9913(23)00163-7"},{"key":"2026062609355654000_16.3.e109072.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60243-2"},{"key":"2026062609355654000_16.3.e109072.4","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1002\/acr.24131","article-title":"2019 American College of Rheumatology\/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee","volume":"72","author":"Kolasinski","year":"2020","journal-title":"Arthritis Care & Research"},{"key":"2026062609355654000_16.3.e109072.5","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2011.150078"},{"key":"2026062609355654000_16.3.e109072.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207241"},{"key":"2026062609355654000_16.3.e109072.7","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1038\/s41584-018-0095-4","article-title":"Hand osteoarthritis: clinical phenotypes, molecular mechanisms and disease management","volume":"14","author":"Marshall","year":"2018","journal-title":"Nat Rev Rheumatol"},{"key":"2026062609355654000_16.3.e109072.8","doi-asserted-by":"crossref","first-page":"1764","DOI":"10.1016\/S0140-6736(23)01572-6","article-title":"Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial","volume":"402","author":"Wang","year":"2023","journal-title":"The Lancet"},{"key":"2026062609355654000_16.3.e109072.9","doi-asserted-by":"crossref","DOI":"10.1177\/1759720X231158618","article-title":"An update on the use of conventional and biological disease-modifying anti-rheumatic drugs in hand osteoarthritis","volume":"15","author":"Tenti","year":"2023","journal-title":"Ther Adv Musculoskelet Dis"},{"key":"2026062609355654000_16.3.e109072.10","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-02822-0"},{"key":"2026062609355654000_16.3.e109072.11","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2021.676173","article-title":"Interleukin-17A Causes Osteoarthritis-Like Transcriptional Changes in Human Osteoarthritis-Derived Chondrocytes and Synovial Fibroblasts In Vitro","volume":"12","author":"Mimpen","year":"2021","journal-title":"Front Immunol"},{"key":"2026062609355654000_16.3.e109072.12","doi-asserted-by":"publisher","DOI":"10.1038\/s41584-019-0243-5"},{"key":"2026062609355654000_16.3.e109072.13","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0164757","article-title":"Increased Serum Levels of IL-17A and IL-23 Are Associated with Decreased Vitamin D3 and Increased Pain in Osteoarthritis","volume":"11","author":"Askari","year":"2016","journal-title":"PLoS One"},{"key":"2026062609355654000_16.3.e109072.14","doi-asserted-by":"publisher","DOI":"10.12659\/MSM.893771"},{"key":"2026062609355654000_16.3.e109072.15","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1080\/14397595.2016.1205777","article-title":"Serum levels of resistin and interleukin-17 are associated with increased cartilage defects and bone marrow lesions in patients with knee osteoarthritis","volume":"27","author":"Wang","year":"2017","journal-title":"Mod Rheumatol"},{"key":"2026062609355654000_16.3.e109072.16","first-page":"1","article-title":"Interleukin-17 Can Induce Osteoarthritis in Rabbit Knee Joints Similar to Hulth\u2019s Method","volume":"2017","author":"Wang","year":"2017","journal-title":"Biomed Res Int"},{"key":"2026062609355654000_16.3.e109072.17","doi-asserted-by":"crossref","DOI":"10.1016\/j.joca.2018.02.258","article-title":"Inhibition of interleukin-17-induced effects in osteoarthritis - an in vitro study","volume":"26","author":"Mimpen","year":"2018","journal-title":"Osteoarthr Cartil"},{"key":"2026062609355654000_16.3.e109072.18","doi-asserted-by":"crossref","DOI":"10.3390\/diagnostics15111335","article-title":"Serum Interleukin-17 and Its Association with Inflammation and Bone Remodeling in Rheumatoid Arthritis and Hand Osteoarthritis: Insights from Musculoskeletal Ultrasound","volume":"15","author":"Ebaid","year":"2025","journal-title":"Diagnostics (Basel)"},{"key":"2026062609355654000_16.3.e109072.19","first-page":"1481","article-title":"Vunakizumab: First Approval","volume":"84","author":"Keam","year":"2024","journal-title":"Drugs (Abingdon Engl)"},{"key":"2026062609355654000_16.3.e109072.20","doi-asserted-by":"crossref","first-page":"3281","DOI":"10.1007\/s10067-019-04661-8","article-title":"Reliability and validity of Simplified Chinese version of Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire: cross-cultural adaptation and validation","volume":"38","author":"Cao","year":"2019","journal-title":"Clin Rheumatol"},{"key":"2026062609355654000_16.3.e109072.21","first-page":"1705","article-title":"Cross cultural adaptation and validation of the Chinese Health Assessment Questionnaire for use in rheumatoid arthritis","volume":"25","author":"Koh","year":"1998","journal-title":"J Rheumatol"},{"key":"2026062609355654000_16.3.e109072.22","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.131086"},{"key":"2026062609355654000_16.3.e109072.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2006.11.009"},{"key":"2026062609355654000_16.3.e109072.24","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780390221"},{"key":"2026062609355654000_16.3.e109072.25","doi-asserted-by":"crossref","unstructured":"Li J , Yang T , Zhang Y , et al . Cohort Profile: The Xiangya Osteoarthritis (XO) Study. Int J Epidemiol 2024;53. doi:10.1093\/ije\/dyae156","DOI":"10.1093\/ije\/dyae156"},{"key":"2026062609355654000_16.3.e109072.26","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1177\/15589447241235344","article-title":"Estimating the Minimal Clinically Important Difference on the Visual Analogue Scale for Carpometacarpal Thumb Joint Osteoarthritis","volume":"20","author":"Olaiya","year":"2025","journal-title":"Hand (N Y)"},{"key":"2026062609355654000_16.3.e109072.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2004.02.001"},{"key":"2026062609355654000_16.3.e109072.28","doi-asserted-by":"crossref","DOI":"10.1186\/s12874-022-01600-1","article-title":"Minimal important difference and patient acceptable symptom state for the Numerical Rating Scale (NRS) for pain and the Patient-Rated Wrist\/Hand Evaluation (PRWHE) for patients with osteoarthritis at the base of thumb","volume":"22","author":"Stjernberg-Salmela","year":"2022","journal-title":"BMC Med Res Methodol"},{"key":"2026062609355654000_16.3.e109072.29","doi-asserted-by":"crossref","unstructured":"Cohen J . Statistical power analysis for the behavioral sciences. 2013. Available: https:\/\/www.taylorfrancis.com\/books\/9781134742707","DOI":"10.4324\/9780203771587"},{"key":"2026062609355654000_16.3.e109072.30","doi-asserted-by":"publisher","DOI":"10.2307\/2291635"},{"key":"2026062609355654000_16.3.e109072.31","unstructured":"Team RC . R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2025. Available: http:\/\/www R-project org\/"},{"key":"2026062609355654000_16.3.e109072.32","doi-asserted-by":"crossref","unstructured":"StataCorp L . Stata statistical software: release 19. 2025","DOI":"10.4324\/9781032717425-3"},{"key":"2026062609355654000_16.3.e109072.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2015.03.007"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-109072","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T16:39:12Z","timestamp":1782491952000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-109072"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":33,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3,10]]},"published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1136\/bmjopen-2025-109072"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-109072","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]}}}