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Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): protocol for a multicentre, randomised controlled trial.

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Title: Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): protocol for a multicentre, randomised controlled trial.
Authors: Fu K; Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China kaifu@sjtu.edu.cn zhangcq@sjtu.edu.cn., Yu SP; Department of Rheumatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.; Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Zheng W; Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China., Bracken K; Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Ding C; Clinical Research Centre, Zhujiang Hospital of Southern Medical University, Guangzhou, China.; Institute of Exercise and Rehabilitation Science, Zhujiang Hospital of Southern Medical University, Guangzhou, China.; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.; Clinical Research Centre, Beijing Tsinghua Changgung Hospital, Tsinghua Medicine, Tsinghua University, Beijing, China., Mei Y; Department of Rheumatology and Immunology, The Second Affiliated Hospital, School of Medicine, Southern University of Science and Technology, Shenzhen, China., Wei J; Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China.; Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China.; Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China., Lei G; Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China.; Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China.; Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China., Wang X; Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zhao Y; Department of Rheumatology, First Affiliated Hospital of Harbin Medical University, Harbin, China., Zhang J; Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China.; Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China., Zheng Y; Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China.; Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China., Xie D; Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China.; Key Laboratory of Aging-related Bone and Joint Diseases Prevention and Treatment, Ministry of Education, Xiangya Hospital, Central South University, Changsha, China.; Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China., Jie L; Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China., Qi W; Clinical Research Centre, Zhujiang Hospital of Southern Medical University, Guangzhou, China.; Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China., Venkatesha V; Northern Sydney Local Health District Executive, Royal North Shore Hospital, St Leonards, New South Wales, Australia., Zhu Z; Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zheng X; Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zhang C; Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China kaifu@sjtu.edu.cn zhangcq@sjtu.edu.cn., Hunter DJ; Department of Rheumatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.; Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Source: BMJ open [BMJ Open] 2026 Mar 10; Vol. 16 (3), pp. e109072. Date of Electronic Publication: 2026 Mar 10.
Publication Type: Journal Article; Clinical Trial Protocol
Language: English
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Imprint Name(s): Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms: Osteoarthritis*/drug therapy , Antibodies, Monoclonal, Humanized*/therapeutic use , Antibodies, Monoclonal, Humanized*/administration & dosage , Hand Joints*, Interleukin-17/antagonists & inhibitors ; Humans ; Double-Blind Method ; Aged ; Middle Aged ; Adult ; Aged, 80 and over ; Male ; Female ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic ; Treatment Outcome ; Pain Measurement ; Quality of Life ; Hand Strength
Abstract: Introduction: 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.
Methods and Analysis: This multicentre, randomised, placebo-controlled, double-blind trial will enrol 150 participants aged 30-80 years with symptomatic erosive hand OA. Participants will be randomised in a 1:1 ratio to receive either vunakizumab 120 mg or placebo subcutaneously every 4 weeks for 24 weeks, with a loading dose injection period during the first 4 weeks. 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.
Ethics and Dissemination: Written informed consent will be obtained from all participants. The study was approved by the Ethics Committee of Shanghai Sixth People's Hospital (2024-217) and will adhere to the Declaration of Helsinki. Research results will be published in peer-reviewed journals.
Trial Registration Number: ChiCTR2500101031; https://www.chictr.org.cn/showproj.html?proj=264789.
(© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)
Competing Interests: Competing interests: DJH is the editor of the osteoarthritis section for UpToDate, co-Editor in Chief of Osteoarthritis and Cartilage and board member of Osteoarthritis Research Society International. DJH provides consulting advice on scientific advisory boards for Pfizer, Lilly, TLCBio, Novartis, Tissuegene and Biobone.
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Contributed Indexing: Keywords: Drug Therapy; Patient Reported Outcome Measures; RHEUMATOLOGY; Randomized Controlled Trial
Substance Nomenclature: 0 (Antibodies, Monoclonal, Humanized)
0 (Interleukin-17)
Entry Date(s): Date Created: 20260310 Date Completed: 20260311 Latest Revision: 20260813
Update Code: 20260813
PubMed Central ID: PMC12983775
DOI: 10.1136/bmjopen-2025-109072
PMID: 41807001
Database: MEDLINE
Description
ISSN:2044-6055
DOI:10.1136/bmjopen-2025-109072