NCT06846515进行中（未招募）3 期
A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout
Arthrosi Therapeutics83 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2025年3月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
- 试验地点
- 83
- 主要终点
- Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
研究概览
简要总结
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of gout
- •Occurrence of ≥ 2 self-reported gout flares in the last 12 months
- •Body weight no less than 50 kg
- •Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
- •Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
- •Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 30 mL/min
排除标准
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •Pregnant or breastfeeding
- •History of symptomatic kidney stones within the past 6 months
研究组 & 干预措施
AR882 75 mg
Experimental
AR882 75 mg taken once daily for 12 months
干预措施: AR882 75 mg (Drug)
AR882 50 mg
Experimental
AR882 50 mg taken once daily for 12 months
干预措施: AR882 50 mg (Drug)
Placebo
Placebo Comparator
AR882 matching placebo taken once daily for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
时间窗: 24 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6
次要结局
- Change in tophus burden by month 6(24 weeks)
- Change in tophus burden by month 12(48 weeks)
- Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12(12 weeks)
- Incidence of Adverse Events(56 weeks)
研究者
研究点 (83)
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