Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases

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What is this study about?

This clinical trial is focused on studying a group of diseases known as Systemic Autoimmune Rheumatic Diseases that are associated with a lung condition called Interstitial Lung Disease (SARD-ILD). These diseases can cause inflammation and scarring in the lungs, leading to breathing difficulties. The study is testing a new treatment called nerandomilast, which is being developed to help manage lung fibrosis, a type of lung scarring, in people with these conditions.

The purpose of the study is to evaluate the effectiveness and safety of nerandomilast over a period of 26 weeks. Participants in the study will receive either the active medication, nerandomilast, or a placebo, which looks like the medication but does not contain the active ingredient. The study will monitor changes in lung health using a special type of imaging called high-resolution computed tomography (HRCT), which provides detailed pictures of the lungs. The study will also track any side effects and changes in symptoms such as cough and shortness of breath.

Participants will be involved in the study for about six months, during which they will have regular check-ups and assessments to monitor their lung condition and overall health. The study aims to provide valuable information on whether nerandomilast can improve lung function and quality of life for people with SARD-ILD. This research could lead to new treatment options for those affected by these challenging conditions.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to test whether nerandomilast helps people with lung fibrosis related to rheumatic diseases.

The participant will be required to provide consent to participate in the study, acknowledging understanding of the trial’s procedures and potential risks.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current medications.

A high-resolution computed tomography (HRCT) scan will be performed to assess lung condition.

3 randomization

Participants will be randomly assigned to receive either the nerandomilast or a placebo. A placebo is a substance with no active medication, used to compare effects.

This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

4 treatment phase

Participants will take the assigned treatment orally in the form of a film-coated tablet.

The treatment will be administered over a period of 26 weeks, with specific dosage and frequency determined by the study protocol.

5 regular monitoring

Throughout the 26-week period, participants will undergo regular monitoring to assess the treatment’s effects on lung condition.

This includes periodic HRCT scans and other assessments to measure changes in lung function and symptoms.

6 final assessment

At the end of the 26-week treatment period, a final assessment will be conducted.

This will include a comprehensive evaluation of lung condition and overall health to determine the treatment’s efficacy and safety.

Who Can Join the Study?

  • The participant must have a condition called Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD). This means they have a specific type of lung disease related to autoimmune diseases.
  • The participant must have been diagnosed by a rheumatologist with one of the following conditions: Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc) but must be negative for anticentromere auto-antibodies, Idiopathic Inflammatory Myopathy (IIM), Sjögren’s disease, or Mixed Connective Tissue Disease (MCTD).
  • The participant must have a type of lung damage called fibrotic ILD visible on a special lung scan called High-Resolution Computed Tomography (HRCT). This means there is a specific pattern of lung damage seen on the scan.
  • The participant must not have shown improvement in lung function or significant improvement in their lung disease despite treatment with immune-suppressing therapy. This is determined by specific lung function tests and the judgment of a doctor.
  • The participant’s lung function, measured by a test called Forced Vital Capacity (FVC), must be at least 45% of what is considered normal.
  • The participant’s ability to transfer oxygen from their lungs to their blood, measured by a test called Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), must be at least 25% of what is considered normal.
  • The participant must have been on a stable treatment with any immune-suppressing medication for at least 6 months (or at least 3 months for those with IIM-ILD). If they are using a medication called prednisone, the dose must have been stable for at least 4 weeks. If they are using a medication called rituximab, they must have completed their first cycle more than 6 months ago.
  • If the participant is using a medication called nintedanib, they must have been on a stable dose for at least 12 weeks.
  • The doctor must believe that there will be no changes in the participant’s current treatment plan with immune-suppressing medications or nintedanib.
  • Additional criteria may apply.
  • Participants can be of any gender.
  • Participants must not be part of a vulnerable population.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse in the past year.
  • Patients who are participating in another clinical trial.
  • Patients who have had a major surgery in the past three months.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a condition that affects their ability to understand or follow study instructions.
  • Patients who have been treated with certain medications that could interfere with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Medical University Of Vienna Vienna Austria
Krankenhaus Porz Am Rhein gGmbH Cologne Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Johannes Wesling Klinikum Minden Minden Germany
Hospital Universitario Basurto Bilbao Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Universitaetsklinikum Krems Krems An Der Donau Austria
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Rennes Rennes France
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Klinikum Konstanz GmbH Konstanz Germany
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
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Euywkcf Uqknfrooqaaz Mrxsukm Cywybdf Rydxjcvlx (rcxqkzb Mng Rotterdam The Netherlands
Kypalqpe dzt Uukvrdspufrk Mtlgogeu Acr Munich Germany
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Hcjdswmw Dv Li Srvob Cedh I Seya Phk Barcelona Spain
Ubzidvvdlw Dviwb Sexfk Dn Rezp Lj Sqnqitrk Rome Italy
Cmovpr Hfhmflyilyh Rgmirwhm Ddnozpdyqkkssp Angers France
Hcmchule Vjre dcvidskz Barcelona Spain
Hpauyknl Umcwqusrllpgqw Sxihvjcdst &gaukrm Hppvhfv dt Httyybpjmgq STRASBOURG, Alsace France
mneonr Kvqbiskb gqeml Ostfildern Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
21.08.2025
France France
Recruiting
21.08.2025
Germany Germany
Recruiting
21.08.2025
Italy Italy
Recruiting
21.08.2025
Norway Norway
Recruiting
21.08.2025
Spain Spain
Recruiting
21.08.2025
The Netherlands The Netherlands
Recruiting
21.08.2025

Trial locations

Nerandomilast is a medication being tested to see if it can help people with certain lung problems that are related to autoimmune diseases. These diseases cause the body’s immune system to attack its own tissues, and in this case, it affects the lungs. The trial is looking at how well this medication can reduce lung damage over a period of 26 weeks. The goal is to see if nerandomilast can improve lung health by reducing the extent of lung involvement, which is measured using special imaging techniques.

Nintedanib is another medication that is part of this trial. It is already known to help with certain lung conditions by slowing down the worsening of lung function. In this study, it is used to see if it can work alongside nerandomilast to provide better outcomes for patients with lung issues related to autoimmune diseases. The trial will observe how nintedanib affects the lungs when used in combination with other treatments over the 26-week period.

Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD) – This condition involves a group of autoimmune diseases that affect the connective tissues and can lead to inflammation and scarring of the lungs, known as interstitial lung disease. The disease progresses as the immune system mistakenly attacks the body’s own tissues, causing inflammation in the lungs. Over time, this inflammation can lead to fibrosis, or thickening and scarring of lung tissue, which can impair lung function. Patients may experience symptoms such as shortness of breath, a persistent dry cough, and fatigue. The progression of lung involvement can vary, with some individuals experiencing a slow progression while others may have a more rapid decline in lung function. The extent of lung damage can be assessed using imaging techniques like high-resolution computed tomography.

Trial ID:
2024-512849-17-00
Protocol code:
1305-0046
Trial Phase:
Therapeutic confirmatory (Phase III)

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