2023-507353-15-00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)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.131 个研究点 分布在 10 个国家目标入组 566 人开始时间: 2024年4月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 566
- 试验地点
- 131
- 主要终点
- 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
The main objective is to assess the long-term tolerability, safety, and efficacy of oral nerandomilast treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER™-IPF] and 1305-0023 [FIBRONEER™-ILD]), and phase IIa 1305-0035. The primary objective of the trial is to descriptively assess the incidence of patients with any adverse event. There will be no treatment comparison and the assessment will be while on treatment.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information. 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 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 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 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 AESI except for latent tuberculosis (suspected vasculitis, 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.
结局指标
主要结局
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.
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.
次要结局
- Absolute change from baseline in FVC (mL) and in % predicted FVC over time
- Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
- Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
- Time to first acute IPF/PPF exacerbation or death over the duration of the trial
- Time to hospitalisation for respiratory cause or death over the duration of the trial
- Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
- Time to relative decline in FVC % predicted of >10% from baseline or death over the duration of the trial
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (131)
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