A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment

Launched by BOEHRINGER INGELHEIM · Jun 17, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called BI 765423 to see if it can help improve lung function in adults with idiopathic pulmonary fibrosis (IPF), a lung condition that causes scarring and makes it hard to breathe. The study will compare this medicine to a placebo (a treatment with no active medicine) over three months to check if lung capacity gets better. Participants may continue their usual IPF treatments during the study. The medicine is given through a vein every four weeks, and the study lasts about 8 to 10 months, with regular visits to check lung health and overall well-being.

Adults aged 40 or older with confirmed IPF who have moderate lung function (at least 45% of the expected lung capacity) and visible lung scarring on scans may be eligible. To join, participants must meet certain health criteria and should not have had recent lung infections, severe heart problems, or other serious conditions. During the study, doctors will regularly measure lung function, take blood samples, and monitor for any side effects to see if BI 765423 is safe and effective. This study is not yet recruiting but aims to find better ways to help people living with IPF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 1. 40 years of age or older at the time of informed consent signature.
• • 2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• 3. Male or female patients. Male patients with Woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period after last drug intake. Women can only be included if they are of non-childbearing potential, defined as meeting at least one of the below conditions:
• • Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
• * Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases of postmenopausal status:
• • Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L"
• • 4. Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Guideline and, if available, surgical lung biopsy or transbronchial lung cryobiopsy histopathology report.
• • 5. Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2).
• • Patients with an "indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" pattern.
• • Patients with an "alternative diagnosis" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" pattern."
• • 6. Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review.
• • 7. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
• • 8. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
• • Further inclusion criteria apply.
• Exclusion criteria:
• • 1. Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
• • 2. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
• • 3. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
• 4. Significant PH defined by any of the following:
• • Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
• • History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^²
• • PH requiring parenteral therapy with prostanoids
• • 5. On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded.
• • 6. Cardiovascular comorbidities including
• • Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
• • Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1
• • Unstable cardiac angina within 6 months of Visit 1
• • 7. Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).
• • Further exclusion criteria apply.