2025-525016-41-00招募中2 期
A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)
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
- 139
- 试验地点
- 103
- 主要终点
- Change from baseline in FVC (mL)
研究概览
简要总结
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •IPF diagnosis
- •Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care
- •FVC ≥ 45% predicted of normal
- •DLCO corrected for hemoglobin ≥ 25% predicted of normal
排除标准
- •ILD other than IPF
- •The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
- •Acute exacerbation of IPF
- •Lower respiratory tract infection requiring treatment
- •Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting
- •Heart failure
- •History of organ transplantation or is likely to receive lung transplantation
研究组 & 干预措施
AZD8965, AZD8965
Test
干预措施: AZD8965 (Drug)
Placebo to AZD8965
Placebo
干预措施: Placebo to AZD8965 (Drug)
结局指标
主要结局
Change from baseline in FVC (mL)
Change from baseline in FVC (mL)
次要结局
- 1. Change from baseline in FVC (mL)
- 2. Change from baseline in % predicted FVC
- 3. Slope (rate of decline) in FVC (mL/week)
- 4. AEs, DAEs, SAEs, AESIs, vital signs, clinical laboratory assessments (eg, clinical chemistry, hematology, urinalysis), ECGs
- 5. AZD8965 plasma concentrations
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (103)
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