A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,202
- 试验地点
- 264
- 主要终点
- The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
研究概览
简要总结
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
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
- •Male or female subjects between the ages of 18 85 years, inclusive.
- •Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
- •Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
- •Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
排除标准
- •Subjects with secondary hyperuricemia and enzymatic defects.
- •Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
- •Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
- •Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
- •Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).
研究组 & 干预措施
Tigulixostat 100mg
Tigulixostat 100mg, Once a day (QD) for up to 12 months
干预措施: Tigulixostat (Drug)
Tigulixostat 200mg
Tigulixostat 200mg, Once a day (QD) for up to 12 months
干预措施: Tigulixostat (Drug)
Tigulixostat 300mg
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
干预措施: Tigulixostat (Drug)
Titrated allopurinol (100-800mg)
Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.
干预措施: Allopurinol (Drug)
Placebo
Placebo, three times a day (TID) for up to 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
时间窗: Up to Month 6
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
次要结局
- Incidence rate of adverse event(Up to Month 12)
- Proportion of subjects with complete resolution of ≥1 target tophus by Month 12(Up to Month 12)
- Proportion of subjects with at least one gout flare from Month 6 to Month 12.(From Month 6 to Month 12)
- The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6(Up to Month 6)