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
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Aarau, Basilea
(BASEC)
Sponsor
Boehringer Ingelheim International GmbH IQVIA AG, Branch Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
10.10.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Inclusione del primo partecipante
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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