2024-512803-37-00已完成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 Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.115 个研究点 分布在 10 个国家目标入组 303 人开始时间: 2024年9月18日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 115
- 主要终点
- Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52
研究概览
简要总结
"The trial will evaluate efficacy and safety of BI 1015550. The primary objective is to demonstrate a reduction in lung function decline as measured by the change from baseline in FVC for BI 1015550 when compared to placebo in patients with progressive fibrosing ILDs."
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old at the time of signed informed consent.
- •Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial.
- •Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed; see study protocol)
- •Patients may be either: -- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. *stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks. -- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either AF-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment."
- •Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
- •DLCO corrected for Hemoglobin (Hb) [Visit 1] ≥25% predicted of normal at Visit
- •Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
- •Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. MTX, AZA) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
排除标准
- •Prebronchodilator FEV1/FVC <0.7 at Visit 1
- •In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- •Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
- •Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
- •Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement).
- •Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery."
- •Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit
- •Further exclusion criteria apply
结局指标
主要结局
Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52
Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52
次要结局
- Time to death over the duration of trial
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
- Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
- Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial
- Time to hospitalization for respiratory cause or death over the duration of trial
- Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
- Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
- Absolute change from baseline in FVC % predicted at Week 52
- Absolute change from baseline in DLCO % predicted at Week 52
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (115)
Loading locations...
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