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Study of BI 765423 given by intravenous infusion for patients with idiopathic pulmonary fibrosis with or without standard treatment

Verified siteInvestigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring of the lung tissue. The research evaluates a new medication called BI 765423, which is given through intravenous administration. The study aims to determine if this new treatment can improve lung function in people with IPF, either when used alone or in combination with standard treatments.

The study uses two different treatments: some participants will receive BI 765423, while others will receive a placebo. Neither the patients nor their doctors will know which treatment is being given. The medication or placebo will be administered through an injection into a vein. The study will track changes in participants' lung function over a period of 12 weeks.

During the study, various measurements will be taken to monitor lung function, including breathing tests and walking tests. Participants will be regularly monitored to ensure their safety throughout the treatment period. The study will last approximately 24 months, during which participants will need to attend multiple clinic visits for assessments and treatment administration.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    A medical evaluation will confirm your diagnosis of idiopathic pulmonary fibrosis (IPF).

    Your lung function will be measured through tests including forced vital capacity (FVC) which must be at least 45% of normal values.

    A chest scan (HRCT) from the past 12 months will be reviewed to confirm at least 20% lung fibrosis.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either BI 765423 or a placebo through intravenous infusion.

    If you are currently on standard IPF treatment, you may continue it during the study.

  3. Step 3

    Treatment period

    The treatment will continue for 12 weeks.

    During this time, you will receive the study medication or placebo through intravenous infusions.

  4. Step 4

    Monitoring visits

    Regular assessments will measure:

    - Your lung function (FVC)

    - Blood oxygen levels

    - Walking distance in a 6-minute walk test

    - Blood tests for specific markers

    - Your breathing capacity (DLCO test)

  5. Step 5

    Final assessment

    After 12 weeks, final measurements will be taken to evaluate changes in your lung function and other health indicators.

    The main focus will be on changes in your FVC measurement compared to the start of the study.

Who can join the trial?

9 criteria

  • Must be 40 years of age or older when signing the consent form
  • Must have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) before the first visit, verified by medical guidelines
  • Must have had a high-resolution CT scan (detailed chest imaging) within the past 12 months showing specific patterns of lung changes
  • Must have lung scarring affecting at least 20% of the lungs, confirmed by chest imaging
  • Must have a Forced Vital Capacity (FVC) of at least 45% of normal (FVC measures the amount of air you can exhale after taking a deep breath)
  • Must have a DLCO of at least 20% of normal (DLCO measures how well oxygen moves from your lungs into your blood)
  • For women: Must be post-menopausal (no menstrual periods for 12 months) or permanently surgically sterilized
  • For men: Must use appropriate contraception if having sexual partners who can become pregnant
  • Must be willing and able to provide written informed consent

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Pregnancy or breastfeeding
  • History of lung transplantation
  • Active infections of the lungs
  • Severe liver disease (where liver is not functioning properly)
  • Severe kidney disease (where kidneys are not functioning properly)
  • Current participation in other clinical trials
  • Known allergies to the study medication or similar drugs
  • Cancer treatment in the past 5 years
  • Unstable heart conditions (such as recent heart attack or severe heart failure)
  • Unable to perform lung function tests correctly
  • Major surgery planned during the study period
  • Alcohol or drug abuse within the past year
  • Mental conditions that could interfere with following study procedures
  • Use of medications that could interact with the study drug
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Investigated drugs

  • BI 765423

    is an investigational medication being studied for the treatment of idiopathic pulmonary fibrosis (a lung condition that causes scarring of the lungs). It is given through intravenous administration (directly into the vein). This medication is being tested to see if it can help improve lung function in patients with this condition.

  • Standard of care

    refers to the current best available treatment that patients typically receive for idiopathic pulmonary fibrosis. This may include currently approved medications that help manage the condition.

What is already known about the treatment

BI 765423 - An investigational medication administered intravenously that is currently being studied in Phase IIa clinical trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This experimental drug is being evaluated both alone and in combination with standard care treatments to assess its safety, effectiveness, and how it moves through and affects the body. The primary goal of the current research is to determine how the medication impacts patients' lung function, specifically measuring changes in forced vital capacity (FVC) compared to placebo over a 12-week period. While the exact molecular mechanism is still under investigation as part of the clinical trials, this drug is being developed as a potential new therapeutic option for patients with IPF, a serious lung condition that causes progressive scarring of lung tissue.

Investigated diseases

Idiopathic Pulmonary Fibrosis (IPF) - A rare lung disease that causes progressive scarring (fibrosis) of lung tissue. The scarring process gradually makes lung tissue thick and stiff, reducing its ability to expand and transfer oxygen into the bloodstream. Over time, this condition causes the lungs to lose their ability to take in and transfer oxygen to the body's vital organs. The term 'idiopathic' means the cause of the scarring is unknown. The disease typically develops slowly, with symptoms including shortness of breath and a dry, persistent cough. The condition primarily affects people over 50 years of age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520658-12-00Protocol code1493-0002Estimated enrolment65 patientsSponsorBoehringer Ingelheim Espana S.A.

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