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

3 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Lungenfachklinik Immenhausen Germany
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital De Galdakao Usansolo Galdakao Spain
Krankenhaus Bethanien gGmbH Solingen Germany
Multimedica S.p.A. Milan Italy
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Clmlpdieo Ulwedurphbdmlx Sdsbyfaja Woluwe-Saint-Lambert Belgium
Huvjgboz Uxukcvwjnibzt Do Ln Pqcoiron Madrid Spain
Efxngub Uxpcxwtuurlo Mlasdlm Crbmszl Rsmpsmkou (gggfutl Mdi Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
19.01.2026
France France
Recruiting
19.01.2026
Germany Germany
Recruiting
19.01.2026
Italy Italy
Recruiting
19.01.2026
Spain Spain
Recruiting
19.01.2026
The Netherlands The Netherlands
Recruiting
19.01.2026

Trial locations

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.

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 ID:
2025-522383-33-00
Protocol code:
1305-0069
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Efficacy and Safety of Subcutaneous Belimumab in Adults with Connective Tissue Disease-Associated Interstitial Lung Disease

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Italy The Netherlands +1
  • A study to evaluate the safety and effectiveness of inhaled treprostinil in patients with pulmonary hypertension associated with interstitial lung disease

    Recruiting

    3 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +4