NCT05119686已完成2 期
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Arthrosi Therapeutics4 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2021年11月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
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 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
- Double (Participant, Investigator)
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
- •sUA > 7 mg/dL
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2
排除标准
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •History of kidney stones
研究组 & 干预措施
Group 1
Experimental
AR882 Dose 1 x 12 weeks
干预措施: AR882 Dose 1 (Drug)
Group 2
Experimental
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
干预措施: AR882 Dose 1 (Drug)
Group 2
Experimental
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
干预措施: AR882 Dose 2 (Drug)
Group 3
Placebo Comparator
AR882 matching placebo x 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
时间窗: 6 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL following 6 weeks of dosing
次要结局
- sUA levels < 5, < 4, and < 3 mg/dL(6 weeks)
- Incidence of Adverse Events(14 weeks)
- Maximum Observed Plasma Concentration (Cmax)(12 weeks)
- Time to observed Cmax (Tmax)(12 weeks)
- Area under the plasma concentration-time curve (AUC)(12 weeks)
研究者
研究点 (4)
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