A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- • To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
研究概览
简要总结
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
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
- •Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
- •Subject has had at least 2 gout flares in the previous 12 months.
- •Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
- •Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
- •Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator
排除标准
- •Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Cohort A
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
干预措施: D-0120 (Drug)
Cohort B
week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol
干预措施: D-0120 (Drug)
Cohort A
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
干预措施: Allopurinol (Drug)
Cohort B
week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol
干预措施: Allopurinol (Drug)
结局指标
主要结局
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
时间窗: 12 weeks
次要结局
未报告次要终点