A Phase 2, Multicenter, Open-label, Efficacy and Safety Study of AR882 and XOI Co-administration in Participants With Uncontrolled Gout Who Have Previously Failed Uricase Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 12
- 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 effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of uncontrolled gout
- •Presence of ≥1 clinically visible tophus
- •Last uricase infusion occurred ≥3 months
- •Body weight no less than 50 kg
- •Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 40 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
- •Received pegloticase, rasburicase or other experimental uricases within the last 3 months
研究组 & 干预措施
AR882 75 mg + XOI
AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period.
干预措施: AR882 75 mg (Drug)
AR882 75 mg + XOI
AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period.
干预措施: XOI Low Dose (Drug)
AR882 75 mg + XOI
AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period.
干预措施: XOI High Dose (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
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)
- Incidence of Adverse Events(56 weeks)