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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Aarau, Basel
(BASEC)
Sponsor
Boehringer Ingelheim International GmbH IQVIA AG, Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
10.10.2025
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar