2024-520206-19-00招募中3 期
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout
Crystalys Therapeutics Inc.17 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2025年10月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 17
- 主要终点
- 1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.
研究概览
简要总结
To evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Investigator, Monitor, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent and any authorizations required by local law.
- •Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- •Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
- •Had at least 2 gout flares in the 12 months prior to Screening
- •Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening.
- •sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
- •Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
- •Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.
排除标准
- •History of or presence of kidney stones within 1 year prior to Screening.
- •History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- •Hypersensitivity or intolerance to dotinurad or to colchicine AND NSAIDs.
- •Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse
- •Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
- •Participants with unstable long-term conditions, such as diabetes, high cholesterol, hypertension, asthma, etc.
- •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.
结局指标
主要结局
1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.
1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.
次要结局
- 1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive.
- 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64.
- 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.
研究者
Chief Medical Officer
Scientific
Crystalys Therapeutics Inc.
研究点 (17)
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