JPRN-jRCT2031220317进行中（未招募）3 期
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF)
Saito Isao0 个研究点目标入组 963 人开始时间: 2022年9月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients 40 years old and elder at the time of signed informed consent.
- •-Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- •-Forced Vital Capacity (FVC) 45% and grater of predicted normal
- •-Diffusing Capacity for Carbon Monoxide (DLCO) 25% and grater and less than 90% predicted of normall
- •-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
排除标准
- •-Relevant airways obstruction (prebronchodilator FEV1/FVC less than 0.7)
- •-Acute IPF exacerbation within 3 months and/or during the screening period
- •-Treated with immunomodulatory medications (other than oral corticosteroids) or prednisone more than15 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
相似试验
招募中
1 期
A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)EUCTR2022-001091-34-EEBoehringer Ingelheim France963
进行中（未招募）
1 期
A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)EUCTR2022-001134-11-GRBoehringer Ingelheim B.V1,041
招募中
1 期
A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)MedDRA version: 23.1Level: LLTClassification code 10084309Term: Progressive fibrosing interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2022-001134-11-ATBoehringer Ingelheim RCV GmbH & Co KG1,041
进行中（未招募）
1 期
Efficacy and safety of nintedanib in patients with PF-ILDEUCTR2015-003360-37-ITBOEHRINGER-INGELHEIM ITALIA S.P.A.1,010
招募中
1 期
A study to find out whether BI 1015550 improves lung function in people with Idiopathic Pulmonary Fibrosis (IPF)EUCTR2022-001091-34-DEBoehringer Ingelheim Pharma GmbH & Co. KG963