A Multi-center, Randomized, Double-blind, Active-controlled, Therapeutic Confirmatory, Phase III Study to Compare and Evaluate the Efficacy and Safety of Epaminurad With Febuxostat in Gout Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
研究概览
简要总结
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for screening
- •≥19 to ≤75 years of age at the time of written informed consent
- •Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
- •Able and willing to actively participate in TLC programme
- •Signed ICF for voluntary study participation
- •for randomization
- •sUA level ≥7.0 mg/dL
- •ACR/EULAR 2015 score ≥8
排除标准
- •Medical history
- •Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.
- •Concurrent disease or laboratory test abnormality
- •Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2
- •History of gout flare between 2 weeks before written informed consent and immediately before randomization
- •Any cardiovascular abnormalities that might affect the study
- •Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
- •Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
- •Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
- •Hypersensitivity to the IP (epaminurad or febuxostat)
- •Pregnant or lactating woman.
研究组 & 干预措施
Epaminurad 9 mg
[Main study period] Epaminurad 9 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 9 mg (Drug)
Febuxostat 80 mg
[Main study period] Febuxostat 80 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 9 mg placebo (Drug)
Febuxostat 80 mg
[Main study period] Febuxostat 80 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 40 mg placebo (Drug)
Febuxostat 80 mg
[Main study period] Febuxostat 80 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 80 mg (Drug)
Epaminurad 6 mg
[Main study period] Epaminurad 6 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 9 mg placebo (Drug)
Epaminurad 6 mg
[Main study period] Epaminurad 6 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 6 mg (Drug)
Epaminurad 6 mg
[Main study period] Epaminurad 6 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 80 mg placebo (Drug)
Epaminurad 9 mg
[Main study period] Epaminurad 9 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 6 mg placebo (Drug)
Febuxostat 40 mg
[Main study period] Febuxostat 40 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 6 mg placebo (Drug)
Febuxostat 40 mg
[Main study period] Febuxostat 40 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 9 mg placebo (Drug)
Febuxostat 80 mg
[Main study period] Febuxostat 80 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Epaminurad 6 mg placebo (Drug)
Epaminurad 9 mg
[Main study period] Epaminurad 9 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 80 mg placebo (Drug)
Epaminurad 6 mg
[Main study period] Epaminurad 6 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 40 mg placebo (Drug)
Epaminurad 9 mg
[Main study period] Epaminurad 9 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 40 mg placebo (Drug)
Febuxostat 40 mg
[Main study period] Febuxostat 40 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 40 mg (Drug)
Febuxostat 40 mg
[Main study period] Febuxostat 40 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
干预措施: Febuxostat 80 mg placebo (Drug)
结局指标
主要结局
Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
时间窗: Week 24
次要结局
- Proportion of subjects with sUA <5 mg/dL at the last 3 time points(Week 16, 20, 24)
- Number of subjects with clinical significant results of Laboratory tests(up to Week 52)
- Proportion of subjects with sUA <5 mg/dL post-dose at each visit(up to Week 24)
- Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24(up to Week 24)
- Percent change from baseline in sUA at each visit(up to Week 24)
- Incidence of gout flare post-dose up to Week 24(up to Week 24)
- Number of subjects with clinical significant results of Electrocardiogram(up to Week 52)
- Proportion of subjects with sUA <6 mg/dL post-dose at each visit(up to Week 24)
- Change from baseline in sUA (mg/dL) at each visit(up to Week 24)
- Adverse events(up to Week 52)
- Number of subjects with clinical significant results of Vital signs(up to Week 52)