A study to investigate whether BI 765423 has an effect on lung function in people with idiopathic pulmonary fibrosis (IPF) with or without standard treatment
Summary description of the study
The aim of this study is to find out whether a drug called BI 765423 is effective in people with idiopathic pulmonary fibrosis (IPF). BI 765423 is intended to reduce lung scarring and improve lung function. To achieve this, it blocks a protein involved in lung fibrosis. Previous studies have shown that BI 765423 is safe and well-tolerated in healthy volunteers. Additionally, it may help slow down or stop the progression of lung fibrosis. This study will help researchers determine whether BI 765423 is a viable treatment option for people with idiopathic pulmonary fibrosis. The goal of this study is to find out whether the investigational drug BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis. The study will compare the effects of BI 765423 with those of a placebo. This will allow researchers to determine if there is a difference in lung capacity after 12 weeks. Furthermore, changes in certain markers related to lung health will be examined during this period.
(BASEC)
Intervention under investigation
This study includes two groups of participants. One group receives the investigational drug BI 765423. The other group receives a placebo. This placebo does not contain the active ingredient of the investigational drug. The respective preparation is administered as an infusion into a vein. Participants are randomly assigned to one of the two groups, with a 50% chance of receiving the investigational drug. The dose of the investigational drug BI 765423 remains unchanged throughout the study.
(BASEC)
Disease under investigation
Idiopathic pulmonary fibrosis (IPF)
(BASEC)
• Age of at least 40 years at the time the consent form is signed • Male participants and female participants not of childbearing potential • Documented diagnosis of idiopathic pulmonary fibrosis prior to visit 1; this must be confirmed by the investigator according to the ATS/ERS/JRS/ALAT guidelines of 2022 (Raghu G, Remy-Jardin M, Richeldi L, et al.). If available, the respective histopathological report of a surgical lung biopsy or a transbronchial cryobiopsy of the lung must also be provided. (BASEC)
Exclusion criteria
• Acute worsening of idiopathic pulmonary fibrosis within at least 12 weeks prior to visit 1 and/or during the pre-screening period (the investigator decides on the allowable period) • Relevant obstruction of the airways at visit 1 (one-second capacity [FEV1]/forced vital capacity [FVC] before the use of a bronchodilator: < 0.7) • Significantly elevated blood pressure in the pulmonary circulation (pulmonary hypertension); this is defined as the presence of one of the following findings: o Previous clinical or echocardiographic evidence of severe right heart failure as assessed by the investigator o Heart index ≤ 2 l/min/m² determined during a previous right heart catheterization o Pulmonary hypertension requiring the use of prostanoids bypassing the gut (parenteral therapy) (BASEC)
Trial sites
Aarau, Basel
(BASEC)
Sponsor
Boehringer Ingelheim International GmbH IQVIA AG, Branch Basel
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Katrin Hostettler Haack
+41 61 265 25 25
katrin.hostettler@clutterusb.chDepartment of Pneumology Universitätsspital Basel Petersgraben 4 CH-4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
10.10.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A double-blind, randomised, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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