2022-501421-20-00已完成3 期
A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients with Hyperuricemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LG Chem Ltd.
- 入组人数
- 690
- 试验地点
- 69
- 主要终点
- Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.
研究概览
简要总结
To compare the efficacy of tigulixostat to appropriately titrated allopurinol (up to 800 mg/day) in achieving sUA levels of <6 mg/dL at Months 4, 5, and 6.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period (12 months)
- 盲法
- Double (Investigator, Subject)
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
- •Subject or the subject’s legally acceptable representative is willing and able to provide written ICF prior to the initiation of any study procedures.
- •Male or female subjects between the ages of 18 and 85 years, inclusive.
- •Subjects with hyperuricemia and a history or presence of gout per ACR/EULAR 2015 criteria (Neogi et al 2015).
- •Subjects who are currently on ULT with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have a sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
- •Subjects with a BMI ≤50 kg/m2 at screening (Visit 1).
- •Subjects with eGFR ≥30 mL/min/1.73m2 at screening (Visit 1).
排除标准
- •Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder or their treatment, organ transplant, therapeutic regimens that produce hyperuricemia, renal failure, renal tubular disorders, lead poisoning, hyperproliferative skin disorders, enzymatic defects (eg, deficient hypoxanthine-guanine phosphoribosyl transferase, glycogen storage diseases)).
- •Subjects experiencing an active acute gout attack within 2 weeks prior to screening (Visit 1).
- •Subjects who are Asian descent (eg, Han Chinese, Korean, Thai) and Black/African descent (eg. African American) with a positive test for HLA B*58:
- •Subjects who have received uricase (e.g., pegloticase).
- •Subjects who have not been receiving stable doses of drugs known to affect sUA levels (losartan, fibrates, thiazide diuretics, loop diuretics, ASA) for the last 3 weeks prior to screening (Visit 1). Acetylsalicylic acid use more than 325 mg/day is not allowed.
- •Subjects with a history of xanthinuria.
结局指标
主要结局
Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.
Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.
次要结局
- Proportion of subjects with sUA levels <5.0 mg/dL sustained at Months 4, 5, and 6.
- Proportion of subjects with at least one gout flare from Month 6 to Month 12.
- Proportion of subjects with complete resolution (100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression) of ≥1 target tophus by Month 12.
- Adverse Events (AEs).
- Serious adverse events (SAEs).
- Treatment-Emergent Adverse events (TEAEs).
- Adverse Events of Special Interest (AESI) including MACE, hepatic injury, renal events, and serious skin and hypersensitivity reactions.
- Physical examinations, vital signs, clinical safety laboratory parameters, or ECGs.
研究者
LG Chem Clinical Research
Scientific
LG Chem Ltd.
研究点 (69)
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