EUCTR2022-001091-34-DE招募中1 期
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 963
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients =40 years old at the time of signed consent
- •IPF diagnosis based on 2022 ATS/ERS/JRS/ALAT Guidelines
- •FVC =45% of predicted normal
- •DLCO =25% predicted of normal corrected for hemoglobin
- •On stable treatment with nintedanib or pirfenidone for at least
- •12 weeks or not on treatment with either nintedanib or pirfenidone for at least 8 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 337
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 626
排除标准
- •Prebronchodilator FEV1/FVC <0.7
- •Acute IPF exacerbation within 3 months and/or during the
- •screening period
- •Treated with immunomodulatory medications (other than oral
- •corticosteroids) or prednisone >15 mg/day or equivalent for
- •respiratory or pulmonary reasons
- •Active, unstable or uncontrolled vasculitis within 8 weeks
- •Any suicidal behaviour in the past 2 years
- •Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months
研究者
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