NCT07089888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 Tophaceous Gout
Crystalys Therapeutics152 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年8月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 152
- 主要终点
- Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous 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
- 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
- •Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- •Diagnosis of gout based on 2015 American College of Rheumatology-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
- •Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day
- •A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
- •sUA level ≥5.0 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 nonsteroidal anti-inflammatory drugs (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.
研究组 & 干预措施
Dotinurad
Experimental
Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter up through Week 76.
干预措施: Dotinurad (Drug)
Allopurinol
Active Comparator
Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24
时间窗: Week 24
次要结局
- Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76(Week 76)
- Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76(Week 76)
- Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24(Week 24)
- Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76(Week 36 through Week 76)
- Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 and No Gout Flares Requiring Treatment from Week 36 Through Week 76(Week 24 and Week 36 through Week 76)
- Mean Change from Baseline in sUA at Week 24(Baseline and Week 24)
- Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit(Baseline to Week 80)
- Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76(Week 36 through Week 76)
- Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit(Up to Week 80)
- Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit(Up to Week 80)
- Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit(Up to Week 80)
- Absolute Change from Baseline in sUA Levels at Each Visit(Baseline to Week 80)
- Percent Change from Baseline in sUA Levels at Each Visit(Baseline to Week 80)
- Percentage of Participants with a Gout Flare Requiring Treatment at Each Month Between Week 24 and the End of Study(Week 24 to Week 80)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 80)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 80)
研究者
研究点 (152)
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