A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 359
- 试验地点
- 195
- 主要终点
- To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
研究概览
简要总结
This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.
详细描述
This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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 medium dose
AZD8965 medium dose
干预措施: AZD8965 medium dose (Drug)
AZD8965 high dose
AZD8965 high dose
干预措施: AZD8965 high dose (Drug)
Placebo for AZD8965
Placebo for AZD8965
干预措施: Placebo for AZD8965 (Other)
AZD8965 low dose
AZD8965 low dose
干预措施: AZD8965 low dose (Drug)
结局指标
主要结局
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
时间窗: at Week 24
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
次要结局
- Relationship between dose and clinical efficacy of AZD8965 at Week 24(Week 24)
- Change from baseline in FVC at Week 24(Week 24)
- Change in rate of decline in FVC at Week 24(Week 24)
- Number of participants with adverse events (AEs)(Up to 25 weeks)
- Number of participants with serious adverse events (SAEs)(Up to 25 weeks)
- Number of participants with AEs leading to discontinuation(Up to 25 weeks)
- Summary statistics to evaluate the PK of AZD8965(From baseline to Week 24)