NCT05936268已完成2 期
A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare
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
- 106
- 试验地点
- 1
- 主要终点
- 72hours target joint VAS change from baseline
研究概览
简要总结
To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy
详细描述
Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) 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
Genacumab group
Experimental
Genakumab 200mg single injection
干预措施: Genakumab for injection (Drug)
cholchicine group
Active Comparator
Colchicine 0.5mg qd po.for 12 weeks
干预措施: Colchicine (Drug)
结局指标
主要结局
72hours target joint VAS change from baseline
时间窗: 72h±2h
72hours target joint VAS change from baseline
次要结局
- Safety outcome(12weeks)
- Recurrence of flare(12 weeks after the last dose)
- Pain intensity(6hours, 24hours, 48hours, 72hours, Day 8,)
- immunogenic outcome(12 weeks after the last dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)GoutGout Initiating Urate-loweringUrate-lowering TherapyNCT05936281Changchun GeneScience Pharmaceutical Co., Ltd.165
终止
2 期
A Study of Guselkumab in Participants With Active Lupus NephritisLupus NephritisNCT04376827Janssen Research & Development, LLC33
已完成
1 期
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy AdultsInterstitial Lung DiseaseNCT05894148Changchun GeneScience Pharmaceutical Co., Ltd.24
已完成
3 期
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque PsoriasisPsoriasisNCT02951533Janssen-Cilag G.m.b.H119
已完成
3 期
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and RetreatmentPsoriasisNCT02207244Janssen Research & Development, LLC992