A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pu… (NCT07036523) | Clinical Trial Compass
RecruitingPhase 2
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
United States71 participantsStarted 2025-11-13
Plain-language summary
This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health.
Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks.
Participants are in the study for 8-10 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. 40 years of age or older at the time of informed consent signature.
✓. 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.
✓. 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:
✓. 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.
✓. 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 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.
What they're measuring
1
Absolute change from baseline in FVC (mL) at 12 weeks
✓. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
✓. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
Exclusion criteria
✕. Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
✕. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
✕. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
✕. Significant PH defined by any of the following:
✕. 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.
✕. Cardiovascular comorbidities including
✕. Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).