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A study to evaluate the effectiveness of BI 1015550 in people with lung abnormalities and a family history of pulmonary fibrosis

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study investigates the effect of nerandomilast in reducing the risk of worsening lung abnormalities in individuals with interstitial lung diseases and a family history of pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes thick and scarred over time. The study also focuses on people with interstitial lung abnormalities, which are early signs of changes in the lungs. Familial pulmonary fibrosis refers to this lung scarring when it runs in a family.

Participants in the study will be given either nerandomilast, which is an oral medication, or a placebo. The purpose of the study is to determine if the medication can help slow down the progression of these lung changes. During the study, researchers will monitor how the lungs function and look for any changes in the lung tissue using high-resolution computed tomography, which is a detailed type of CT scan used to see the lungs more clearly.

The study is designed to last for 24 months. During this time, the effectiveness and safety of the treatment will be observed. Researchers will monitor lung function through various measures, including the amount of air the lungs can hold and how well oxygen moves from the lungs into the blood.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    Once joined, a 24-month period of medication use begins.

    The medication, known as nerandomilast (also referred to as bi 1015550), is taken by mouth in the form of a film-coated tablet.

    The dose provided is either 18 mg or 36 mg of the active substance.

    A placebo, which is a substance that looks like the medicine but has no active ingredients, may be administered instead of the medication.

  2. Step 2

    Monitoring lung function and imaging

    Lung health is monitored throughout the 24-month duration to check for changes in interstitial lung abnormalities (abnormalities in the lung tissue).

    Changes are tracked using fvc, which measures the amount of air that can be forcefully exhaled, and dlco, which measures how well oxygen moves from the lungs into the blood.

    Imaging is performed using a chest hrct (a detailed type of x-ray) to evaluate reticulovascular scores (patterns in the lung tissue) and total disease extent (the overall area affected in the lungs).

  3. Step 3

    Scheduled assessments

    Specific measurements for lung function and imaging are recorded at week 26, week 52, and week 104 to monitor any worsening of the condition.

Who can join the trial?

6 criteria

  • You must be 40 years of age or older at the time you sign the consent forms to join the study.
  • You must have at least one first-degree relative, which means a biological parent, sibling, or child, who has been diagnosed with pulmonary fibrosis (a condition where the lung tissue becomes thick and scarred). This includes specific types like idiopathic pulmonary fibrosis (scarring with no known cause) or nonspecific interstitial pneumonia (a type of lung inflammation and scarring).
  • Your relative's condition may be due to a genetic cause, meaning a condition passed down through family DNA.
  • A special type of chest X-ray called an HRCT scan (high-resolution computed tomography) must show signs of interstitial lung abnormalities (damage or scarring in the tissue between the air sacs of the lungs) covering at least 5% of one part of a lung.
  • Your FVC (forced vital capacity), which is the total amount of air you can forcefully exhale from your lungs, must be at least 80% of the normal level expected for a person of your age and health.
  • Your DLCO (diffusing capacity of the lungs for carbon monoxide), which is a test that measures how well your lungs can transfer gas from the air into your blood, must be at least 70% of the normal level when adjusted for your blood's hemoglobin (the protein in red blood cells that carries oxygen).

Who cannot join the trial?

5 criteria

  • Having a known case of pulmonary fibrosis, which is a condition where the lung tissue becomes thick and scarred, if the doctor believes you need medicine that is already approved for treatment.
  • Having a FEV1/FVC ratio of less than 0.7, which is a measurement used during breathing tests to show how much air you can forcefully exhale and how quickly you can do it.
  • Having results from a high-resolution CT scan (a detailed X-ray of the lungs) that show signs of usual interstitial pneumonia, a specific pattern of lung inflammation and scarring.
  • Having any medical condition that is known to increase the chance of developing pulmonary fibrosis, such as a connective tissue disease, which is a group of disorders that affect the tissues supporting the body, like skin, joints, or muscles.
  • Having used or currently using the medicines nerandomilast, nintedanib, or pirfenidone in the past or at this time.
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Investigated drugs

Nerandomilast is a medication taken by mouth in tablet form. It is being studied to see if it can help reduce the risk of lung abnormalities or scarring getting worse in people who have a family history of pulmonary fibrosis.

What is already known about the treatment

  • Placebo matching BI 1015550

    This is an inactive substance administered in the same way as the study medication to ensure the trial results are accurate. It contains no active medicine and is used as a comparison tool in clinical research to evaluate the effectiveness of the test drug. It is intended to have no therapeutic effect on lung conditions.

  • BI 1015550

    This medication is taken orally in the form of a film-coated tablet and is currently being studied in clinical trials for its potential to treat lung diseases. It belongs to a class of drugs designed to slow down the progression of lung scarring, such as pulmonary fibrosis or interstitial lung diseases. On a molecular level, it works by blocking specific enzymes that trigger inflammation and the buildup of scar tissue in the lungs.

Investigated diseases

  • Interstitial lung diseases

    These are a group of disorders that cause inflammation and scarring in the lungs. The condition occurs when the tissue around the air sacs becomes thickened and stiff. As the disease progresses, the lung tissue loses its elasticity, making it harder for the lungs to expand. This thickening can interfere with the efficient exchange of oxygen and carbon dioxide. The progression varies depending on the specific type of interstitial disease involved.

  • Familial pulmonary fibrosis

    This is a rare form of lung disease characterized by the scarring of lung tissue that is passed down through families due to genetic factors. The condition leads to the buildup of thick, fibrous tissue within the lungs. Over time, this scarring makes the lung tissue stiff and less functional. The disease typically progresses as the lung architecture becomes increasingly distorted by the fibrosis.

  • Pulmonary fibrosis

    This condition involves the progressive scarring and thickening of the lung tissue. As the scarring increases, the lungs become stiff and lose their ability to expand easily. This process makes it difficult for the lungs to transfer oxygen into the bloodstream. The disease moves forward as the fibrous tissue continues to accumulate throughout the lungs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522383-33-00Protocol code1305-0069Estimated enrolment77 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).