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BI 765423 to improve lung function in people with idiopathic pulmonary fibrosis (IPF)

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

Phase 2 Interventional Boehringer Ingelheim · NCT07036523

This study tests whether monthly IV infusions of BI 765423 can increase lung capacity over 3 months in adults aged 40 and older with IPF and at least 20% fibrosis on HRCT.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment71 (estimated)
Ages40 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations47 sites (Birmingham, Alabama and 46 other locations)
Trial IDNCT07036523 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled Phase 2 trial comparing BI 765423 given as an intravenous infusion every four weeks to a matching placebo. Eligible adults (age ≥40) must have FVC ≥45% of predicted and ≥20% fibrosis on high-resolution CT. The primary comparison measures change in lung capacity (FVC) after approximately 3 months of treatment, with additional analyses of blood and imaging markers related to lung health. Total participation lasts about 8–10 months including screening, treatment, and follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 or older with a diagnosis of IPF, FVC at or above 45% predicted, and at least 20% fibrosis visible on HRCT who can receive IV infusions and attend study visits.

Not a fit: People with very advanced disease (FVC below 45%), unable to receive IV infusions, or who do not meet the imaging criteria are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, BI 765423 could slow or improve lung function decline in people with IPF, helping preserve breathing ability.

How similar studies have performed: Other approved anti-fibrotic drugs have shown the ability to slow FVC decline in IPF, but BI 765423 is a novel agent being tested specifically for short-term effects on lung capacity and related biomarkers.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.