BI 765423 for Idiopathic pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- 40 years of age or older at the time of informed consent signature."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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 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: o 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients with an 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients with a FVC ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI)."}
• {"criterion_text":"- Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1."}
• {"criterion_text":"- Further inclusion criteria apply."}

Exclusion criteria

• {"criterion_text":"- Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined)."}
• {"criterion_text":"- Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7) at Visit 1."}
• {"criterion_text":"- Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Cardiovascular comorbidities including o Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1 o Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1 o Unstable cardiac angina within 6 months of Visit 1"}
• {"criterion_text":"- Life expectancy for any concomitant disease other than IPF <2.5 years (investigator assessment)."}
• {"criterion_text":"- Further exclusion criteria apply."}

Primary endpoints

• {"endpoint_text":"- Absolute change from baseline in FVC (mL) at 12 weeks","definition_or_measurement_approach":"Absolute change in forced vital capacity (FVC) from baseline measured in mL at 12 weeks; primary objective is to estimate the absolute difference in means of FVC change from baseline after 12 weeks between BI 765423 and placebo."}

Secondary endpoints

• {"endpoint_text":"- Absolute change from baseline in log10-transformed SP-D plasma concentration at 12 weeks.","definition_or_measurement_approach":"Absolute change from baseline in plasma Surfactant protein D (SP-D) concentration, log10-transformed, measured at 12 weeks; comparison of absolute difference in means between BI 765423 and placebo."}
• {"endpoint_text":"- Absolute change from baseline in distance walked (m) during 6 meter walking test (6MWT) at 12 weeks.","definition_or_measurement_approach":"Absolute change from baseline in distance walked during 6-minute walk test (6MWT) measured in meters at 12 weeks."}
• {"endpoint_text":"- Absolute change from baseline in FVC % predicted at 12 weeks.","definition_or_measurement_approach":"Absolute change from baseline in FVC expressed as % predicted (predicted values per GLI) at 12 weeks."}
• {"endpoint_text":"- Absolute change from baseline in DLCO % predicted at 12 weeks.","definition_or_measurement_approach":"Absolute change from baseline in DLCO (haemoglobin-corrected) expressed as % predicted at 12 weeks."}
• {"endpoint_text":"- Absolute change from baseline in oxygen saturation (SpO2) on room air at rest at 12 weeks.","definition_or_measurement_approach":"Absolute change from baseline in resting oxygen saturation (SpO2) on room air measured at 12 weeks."}

Methods

• Use of recruitment materials (flyers) targeted at patients with idiopathic pulmonary fibrosis — country-specific recruitment flyers/documents present (k2_recruitment-material-flyer files for Belgium (EN/DUT/FRE), Germany (DE), Italy (IT), Spain (ES) and others).
• Recruitment arrangements/procedure documents (k1_recruitment-arrangements-procedure) available per country (e.g. DE, ES, BE, IT) indicating organised site-level recruitment processes.

Germany

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

24-10-2025

Processing Time Days

52

Number Of Sites

3

Number Of Participants

6

Spain

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

84

Number Of Sites

4

Number Of Participants

5

Belgium

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

21-11-2025

Processing Time Days

60

Number Of Sites

2

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

224

Number Of Sites

5

Number Of Participants

5

Primary sponsor

Full Name

Boehringer Ingelheim International GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Co-sponsors

• Boehringer Ingelheim Espana S.A.