NCT06270225进行中（未招募）2 期
A Randomized, Open-label, Active-Controlled Phase II Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Numbers of acute gout flares
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.
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
- •Must be 18 Years to 75 Years, both male and female.
- •BMI ≤40 kg/m
- •Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
- •≥2 acute gout flares within 1 year prior to screening.
- •Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.
排除标准
- •Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
- •Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- •Presence of severe renal function impairment.
- •Intolerance of subcutaneous injection.
- •Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
- •Live vaccinations within 8 weeks prior to the start of the study.
- •Use of forbidden therapy
研究组 & 干预措施
SSGJ-613 100 mg
Experimental
Subjects will receive 100mg SSGJ-613 on Day 1.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (Drug)
SSGJ-613 200 mg
Experimental
Subjects will receive 200mg SSGJ-613 on Day 1.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (Drug)
Colchicine 0.5mg
Active Comparator
Subjects will receive 0.5mg/d Colchicine for 12 weeks.
干预措施: Colchicine 0.5 mg (Drug)
结局指标
主要结局
Numbers of acute gout flares
时间窗: 12 weeks
次要结局
- Numbers of acute gout flares(24 weeks)
- Duration of acute gout flares.(24 weeks)
- Subject's overall assessment of response to treatment(24 weeks)
- Proportions of subjects with at least 1 acute gout flare(24 weeks)
- Investigator's overall assessment of response to treatment(24 weeks)
- Adverse events (AE)(24 weeks)
- Time from randomization to first acute flare.(24 weeks)
- 36-item Short Form Survey (SF-36)(24 weeks)
研究者
研究点 (1)
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