NCT06276556终止2 期
A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.54 个研究点 分布在 5 个国家目标入组 580 人开始时间: 2024年4月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 580
- 试验地点
- 54
- 主要终点
- Incidence of treatment-emergent adverse events (Safety and Tolerability)
研究概览
简要总结
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1 or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301
排除标准
- •Has a new medical or psychological condition that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the Extension Study, or potentially compromise the results or interpretation of the Extension Study.
- •Is planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug.
- •Is intolerant or unwilling to take colchicine or naproxen.
研究组 & 干预措施
ABP-671
Experimental
干预措施: ABP-671 (Drug)
Allopurinol
Active Comparator
干预措施: Allopurinol (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (Safety and Tolerability)
时间窗: Week 26
Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
时间窗: Week 26
次要结局
- Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)(Week 26)
研究者
研究点 (54)
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