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Study on BI 1819479 to Improve Lung Function in Patients with Idiopathic Pulmonary Fibrosis

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What is this trial about?

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

This clinical trial is focused on studying idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The study will test a new treatment called BI 1819479, which is taken as a film-coated tablet. The purpose of the study is to see if BI 1819479 can improve lung function in people with IPF.

Participants in the study will be randomly assigned to receive either BI 1819479 or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for at least 24 weeks, and participants will take the medication orally. The researchers aim to find the most effective dose of BI 1819479 by comparing different doses to the placebo.

Throughout the study, the main focus will be on measuring changes in lung function, specifically the rate at which lung capacity declines over time. This will help determine if BI 1819479 can slow down the progression of IPF. The study will also look at the safety and tolerability of the medication to ensure it is safe for patients to use.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the medication BI 1819479 or a placebo. The placebo is a tablet that looks identical to the medication but does not contain the active substance.

    The study is designed to be double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  2. Step 2

    Medication administration

    The patient will take the assigned tablet orally. The specific dosage and frequency will be determined by the study protocol, which aims to evaluate different doses of BI 1819479.

    The treatment period will last for at least 24 weeks, with the possibility of extending up to a maximum of 52 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's lung function will be regularly monitored. This includes measuring the Forced Vital Capacity (FVC), which is the amount of air the patient can forcibly exhale from the lungs after taking the deepest breath possible.

    The primary goal is to assess the annual rate of decline in FVC over the treatment period.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, the patient will undergo a final evaluation to measure any changes in lung function, specifically the absolute change in FVC from the baseline at Week 24.

    The results will help determine the effectiveness and safety of BI 1819479 in treating idiopathic pulmonary fibrosis.

Who can join the trial?

8 criteria

  • Patients must be **40 years or older** at the time they sign the consent form.
  • Must provide a **signed and dated written consent** form, following international and local guidelines, before joining the trial.
  • Must have a **diagnosis of idiopathic pulmonary fibrosis (IPF)** based on specific medical guidelines from 2022.
  • Must be on a stable treatment with either **nintedanib or pirfenidone** for at least 12 weeks, or not on these treatments for at least 12 weeks.
  • Must have a **Forced Vital Capacity (FVC)** of at least 45% of what is considered normal. FVC is a test that measures how much air you can exhale after taking a deep breath.
  • Must have a **DLCO** of at least 25% of what is considered normal, adjusted for hemoglobin levels. DLCO is a test that measures how well your lungs transfer oxygen into your blood.
  • **Women of childbearing potential** must use highly effective birth control methods and an additional barrier method, like a condom, for their male partners until the end of the follow-up period.
  • **Male participants** with partners who can become pregnant must use condoms to prevent exposure through seminal fluid. Their female partners must also use highly effective birth control methods during the treatment and until the end of the follow-up period.

Who cannot join the trial?

10 criteria

  • Patients with any other lung disease besides idiopathic pulmonary fibrosis cannot participate. Idiopathic pulmonary fibrosis is a condition where the lungs become scarred and breathing becomes difficult.
  • Patients who have had a recent lung infection or illness that affects their breathing are not eligible.
  • Patients who have undergone lung surgery in the past 6 months cannot join the study.
  • Patients who are currently taking medications that might interfere with the study treatment are excluded.
  • Patients with a history of severe heart problems are not allowed to participate.
  • Patients who have been diagnosed with cancer in the past 5 years are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with a known allergy to the study medication or its ingredients cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
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Investigated drugs

BI 1819479 is an investigational medication being studied for its potential to treat idiopathic pulmonary fibrosis (IPF). This medication is being tested to see how effective and safe it is for patients with this lung condition. The study aims to find the best dose that provides the most benefit with the least side effects.

What is already known about the treatment

BI 1819479 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating idiopathic pulmonary fibrosis (IPF). It is not yet approved for general medical use, as it is still under investigation to determine its efficacy, safety, and optimal dosing. The main therapeutic indication for BI 1819479 is to manage and treat IPF, a condition characterized by progressive scarring of lung tissue. At the molecular level, BI 1819479 is believed to work by modulating specific pathways involved in the fibrotic process, although the exact mechanism is still being researched. It falls under the pharmacological classification of investigational drugs, as it is not yet classified within a specific drug category due to its ongoing evaluation in clinical trials.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The exact cause of the disease is unknown, which is why it is termed "idiopathic." As the disease progresses, individuals may experience increasing difficulty in breathing and reduced oxygen levels in the blood. The condition typically worsens over time, leading to more severe respiratory symptoms. The progression rate can vary among individuals, with some experiencing a more rapid decline in lung function than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508395-11-00Protocol code1462-0004Estimated enrolment293 patientsSponsorBoehringer Ingelheim Espana S.A.

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