{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Kai Fu"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Shirley P Yu"
    },
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Wei Zheng"
    },
    {
      "affiliations": [
        "Sydney Musculoskeletal Health, The Kolling Institute, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Karen Bracken"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Changhai Ding"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Immunology, The Second Affiliated Hospital, School of Medicine, Southern University of Science and Technology, Shenzhen, China"
      ],
      "name": "Yifang Mei"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Jie Wei"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Guanghua Lei"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Xiaodong Wang"
    },
    {
      "affiliations": [
        "Department of Rheumatology, First Affiliated Hospital of Harbin Medical University, Harbin, China"
      ],
      "name": "Yanping Zhao"
    },
    {
      "affiliations": [
        "Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China",
        "Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China"
      ],
      "name": "Jinshan Zhang"
    },
    {
      "affiliations": [
        "Department of Orthopedics, Jinjiang Municipal Hospital, Quanzhou, China",
        "Clinical Research Centre for Orthopaedic Trauma and Reconstruction of Fujian Province, Jinjiang Municipal Hospital, Quanzhou, China"
      ],
      "name": "Yongqiang Zheng"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Dongxing Xie"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China"
      ],
      "name": "Ligang Jie"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Weizhong Qi"
    },
    {
      "affiliations": [
        "Northern Sydney Local Health District Executive, Royal North Shore Hospital, St Leonards, New South Wales, Australia"
      ],
      "name": "Venkatesha Venkatesha"
    },
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Zhenzhong Zhu"
    },
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Xianyou Zheng"
    },
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Changqing Zhang"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "David J Hunter"
    }
  ],
  "title": "Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): protocol for a multicentre, randomised controlled trial",
  "uid": "15efb8dd-1001-5002-a7dd-1498254eee2d"
}