NCT06238622招募中3 期
An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,700
- 试验地点
- 633
- 主要终点
- Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
研究概览
简要总结
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- •Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control
排除标准
- •Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
- •Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
- •any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- •any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- •Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit
- •An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit
- •Patient will undergo lung transplantation, with an assigned date of surgery.
- •Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
- •At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
- •Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- •Further exclusion criteria apply.
研究组 & 干预措施
BI 1015550 treatment group
Experimental
干预措施: Nerandomilast (Drug)
结局指标
主要结局
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
时间窗: Up to 99 weeks and 3 days
次要结局
- Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial(Up to 98 weeks)
- Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial(Up to 98 weeks)
- Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial(Up to 98 weeks)
- Time to hospitalisation for respiratory cause or death over the duration of the trial(Up to 98 weeks)
- Absolute change from baseline in Forced vital capacity (FVC) (mL) over time(Up to 98 weeks)
- Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time(Up to 98 weeks)
- Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial(Up to 98 weeks)
- Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial(Up to 98 weeks)
研究者
研究点 (633)
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