BMJ open · 2026
Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): protocol for a multicentre, randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Fu Kai, Yu Shirley P, Zheng Wei, Bracken Karen, Ding Changhai, Mei Yifang, Wei Jie, Lei Guanghua, Wang Xiaodong, Zhao Yanping, Zhang Jinshan, Zheng Yongqiang, Xie Dongxing, Jie Ligang, Qi Weizhong, Venkatesha Venkatesha, Zhu Zhenzhong, Zheng Xianyou, Zhang Changqing, Hunter David J
Аннотация
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.
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.