A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 12
- 主要终点
- Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
研究概览
简要总结
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
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
- •History of gout
- •at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
- •Patients who are NOT on approved ULT must have sUA > 7 mg/dL
- •Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2
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 kidney stones
研究组 & 干预措施
Group 1
Allopurinol once daily for 24 weeks
干预措施: Allopurinol Tablet (Drug)
Group 2
AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
干预措施: AR882 Dose 1 (Drug)
Group 2
AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
干预措施: AR882 Dose 2 (Drug)
Group 3
AR882 Dose 1 + Allopurinol for 24 weeks
干预措施: AR882 Dose 1 (Drug)
Group 3
AR882 Dose 1 + Allopurinol for 24 weeks
干预措施: Allopurinol Tablet (Drug)
结局指标
主要结局
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
时间窗: 12 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 5 mg/dL at month 3
次要结局
- Change from baseline in tophus area at Months 3 and 6(12 weeks and 24 weeks)
- Change from baseline in tophus crystal volume at Months 6(24 weeks)
- Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3(12 weeks)
- Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6(24 weeks)
- Incidence of Adverse Events(24 weeks)