临床试验/NCT07428499

NCT07428499招募中3 期

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

ADARx Pharmaceuticals, Inc.50 个研究点分布在 19 个国家目标入组 90 人开始时间: 2026年4月2日最近更新: 2026年9月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: ADARx Pharmaceuticals, Inc.
入组人数: 90
试验地点: 50
主要终点: Safety of ADX-324 in Participants with HAE

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.

研究设计

研究类型: Interventional
分配方式: Non 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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Have a documented diagnosis of HAE (Type I or II)
•Completed Study ADX-324-301
•Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)

排除标准

•A negative reaction to study drug in ADX-324-301

研究组 & 干预措施

ADX-324 Dose Level 2

Experimental

干预措施: ADX-324 Dose Level 2 (Drug)

ADX-324 Dose Level 1

Experimental

干预措施: ADX-324 Dose Level 1 (Drug)

结局指标

主要结局

Safety of ADX-324 in Participants with HAE

时间窗: Month 36

Incidence and severity of treatment-emergent adverse events

次要结局

Efficacy of ADX-324 in Preventing HAE Attacks(Month 36)

研究者

发起方

ADARx Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (50)

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