NCT06770088尚未招募4 期
A Prospective, Single-arm, Multicenter Study to Explore the Efficacy and Safety of Vunakizumab in Adults with Active Spondyloarthritis
Sun Yat-sen University0 个研究点目标入组 880 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 880
- 主要终点
- Proportion of patients with spondyloarthritis who achieved ASAS40 response
研究概览
简要总结
This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years when signing the informed consent;
- •Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;
- •The subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study.
排除标准
- •Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;
- •fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug;
- •active infection with important clinical significance;
- •patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);
- •patients with malignant tumors who were receiving treatment or were not receiving treatment;
- •concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment;
- •any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.
研究组 & 干预措施
single arm
Active Comparator
Vunakizumab
干预措施: vnacicizumab (Drug)
结局指标
主要结局
Proportion of patients with spondyloarthritis who achieved ASAS40 response
时间窗: week 16
Proportion of patients with spondyloarthritis who achieved ASAS40 response
次要结局
- The proportion of patients achieving ASAS20(Week 16)
- Proportion of patients with spondyloarthritis who achieved ASAS20 response(Week 52)
研究者
Gu Jieruo
Professor
Sun Yat-sen University
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