2023-510249-79-00招募中2 期
A Phase IIa/IIb, randomised, double blind, placebo-controlled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.71 个研究点 分布在 12 个国家目标入组 100 人开始时间: 2024年8月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 71
- 主要终点
- IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4
研究概览
简要总结
Phase IIa: To demonstrate a meaningful reduction from baseline in 24-h cough frequency in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment. Phase IIb: To demonstrate a non-flat dose-response curve with respect to change from baseline in 24-h cough frequency after 12 weeks of treatment and characterize the dose-response relationship within the therapeutic range of BI 1839100 regarding efficacy and safety.
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
- 否
入选标准
- •IPF cohort: Diagnosis of IPF.
- •PPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
- •PPF cohort: FVC ≥45% of predicted normal at Visit 1
- •PPF cohort: DLCO ≥25% of predicted normal at Visit 1
- •PPF cohort:If receiving immunomodulatory therapy for ILD, allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
- •PPF cohort: Patients may be either: - On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration - Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib therapy for the purpose of participating in this trial
- •PPF cohort: Patients aged >18 years when signing the informed consent
- •Further inclusion criteria apply.
- •IPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment).
- •IPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
- •IPF cohort: FVC ≥45% of predicted normal at Visit
- •IPF cohort: Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit
- •IPF cohort: Patients may be either: - On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed. - Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either AFtreatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic (AF) treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial.
- •IPF cohort: Patients aged ≥40 years when signing the informed consent.
- •PPF cohort: Diagnosis of PPF.
- •PPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment).
排除标准
- •IPF and PPF cohorts: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
- •IPF and PPF cohorts: Forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1
- •IPF and PPF cohorts: Known reversible airflow obstruction/response to bronchodilators
- •IPF and PPF cohorts: In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic or bronchiectatic disorder
- •IPF and PPF cohorts: Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
- •IPF and PPF cohorts: Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
- •IPF and PPF cohorts: Current smokers (tobacco use within the 6 months prior to Visit 1)
- •IPF and PPF cohorts: Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1
- •Further exclusion criteria apply.
结局指标
主要结局
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 12
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 12
次要结局
- IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity NRS score at Week 4
- IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity VAS score (mm) at Week 4
- IPF cohort - Phase IIb: Absolute change from baseline in FVC (mL) at Week 12
- IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% 24-h cough frequency reduction (CC/h) from baseline at Week 12
- IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score at Week 12
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (71)
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