NCT07241546招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase 2a Study of ARO-RAGE Inhalation Solution to Assess Efficacy on Small Airway Dysfunction in Allergen-induced Mild Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Change from Baseline Over Time in Maximum Area of Reactance
研究概览
简要总结
The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable, mild atopic asthma (FEV1 ≥70% predicted)
- •Established allergy confirmed by positive skin prick test at screening
- •Willing and able to perform lung function tests and other study-related procedures
- •Participants of childbearing potential must consent to use a method of highly-effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last investigational product administration, whichever is later
排除标准
- •Concomitant diagnosis of a clinically important pulmonary disease other than asthma
- •Use of corticosteroids, immunosuppressives, or anti-inflammatory medications that interfere with inhaled challenges or inflammation, or chronic use of any other medication for treatment of allergic asthma
- •History or current medical condition contraindicating methacholine challenge
- •Note: Additional inclusion/exclusion criteria may apply per protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
Normal saline (0.9%)
干预措施: Placebo (Drug)
ARO-RAGE
Experimental
ARO-RAGE inhalation
干预措施: ARO-RAGE (Drug)
结局指标
主要结局
Change from Baseline Over Time in Maximum Area of Reactance
时间窗: Baseline through Day 58
次要结局
- Number of Participants with Treatment-Emergent Adverse Events(Up to Day 113 (End of Study))
- Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve(Baseline through Day 58)
- Change from Baseline Over Time in Maximum Change in Small Airway Reactance(Baseline through Day 58)
- Number of Participants with Treatment-Emergent Adverse Events(Up to Day 113, End of Study)
研究者
研究点 (5)
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