NCT05936281已完成2 期
A Randomized, Open-lable, Multi-center, Active-controlled Phase 2 Study for Evaluating Efficacy and Safety of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Mean Number of Gout Flares Per Participant
研究概览
简要总结
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
详细描述
A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Genakumab group
Experimental
Genakumab 100mg single injection、Genakumab 200mg single injection
干预措施: Genakumab for injection (Drug)
Colchicine group
Active Comparator
Oral colchicine 0.5mg once a day for 12 weeks
干预措施: Colchicine (Drug)
结局指标
主要结局
Mean Number of Gout Flares Per Participant
时间窗: Baseline to Week 12
次要结局
- Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization(Baseline to Week 12)
- Time from Randomization to the First Flare(Baseline to Week 12)
- Mean duration of flares(Baseline to Week 12)
- 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 12)
研究者
研究点 (1)
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