A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.

Boehringer Ingelheim RCV GmbH & Co KG0 个研究点目标入组 150 人开始时间: 2020年7月6日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•- Patients aged =40 years when signing the informed consent.
•- Diagnosis:
•-- a. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as confirmed by the investigator based on chest HRCT scan taken within 12 months of Visit 1 and if available surgical lung biopsy. and
•-- b. UIP or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF
•- Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
•-- not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed), or
•-- on stable* therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and planning to stay stable on this background therapy after randomisation.
•- Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1
•- DLCO (corrected for haemoglobin [Hb] [Visit 1]) = 25% to < 80% of predicted normal at Visit 1.
•- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at Visit 1.
•- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
•- Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
•- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
•- Major surgery (major according to the investigator’s assessment) performed within 3 months prior to Visit 1 or planned during the course of the trial. (Being on a transplant list is allowed).
•- 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, under surveillance” prostate cancer or in situ carcinoma of uterine cervix.
•- Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings (see table 5.2.3 :1) at Visit 1 or at Visit 2.
•- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
•- Confirmed infection with SARS-CoV-2 within 4 weeks prior to visit 1 or during screening period.
•- Further criteria apply.

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