A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 41
- 主要终点
- Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
研究概览
简要总结
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 双盲 (受试者、研究者)
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 (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:
- History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
- Failed uricase treatment (eg, an sUA level >6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).
- sUA level >6.0 and <10.5 mg/dL at both Screening Visit 1 (Day -28 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 -28 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 trial 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.
- 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 virus (HCV) during Screening.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.
研究组 & 干预措施
Placebo + Placebo to Dotinuard
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).
干预措施: Placebo (Other)
Placebo + Placebo to Dotinuard
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).
干预措施: Dotinurad (Drug)
Dotinurad
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).
干预措施: Dotinurad (Drug)
结局指标
主要结局
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
时间窗: Week 24
次要结局
- Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24(Weeks 16, 20 and 24)
- Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit(Up to Week 40)
- Mean Change From Baseline in sUA at Week 24(Baseline and Week 24)
- Absolute Change from Baseline in sUA Levels at Each Visit(Baseline to Week 40)
- Percent Change from Baseline in sUA Levels at Each Visit(Baseline to Week 40)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2(Screening to Week 36)
- Number of Participants With TEAEs and SAEs Throughout the Study(Screening to Week 40)
研究者
研究点 (41)
标识符
- NCT 编号
- NCT07535034
- 其他研究编号
- FYU-981-CRYS-201
日期
- 首次提交
- (5个月前)
- 首次发布
- (5个月前)
- 主要完成日期
- (9个月后)
- 研究完成日期
- (10个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Individual participant data that underlie the results reported for publication, after deidentification.