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

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 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.

The research process

The trial runs in 6 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 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

Nerandomilast – Nerandomilast is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating interstitial lung diseases associated with systemic autoimmune rheumatic diseases (SARD-ILD). The main therapeutic indication for nerandomilast is to reduce lung involvement in these conditions. At the molecular level, nerandomilast works by modulating inflammatory pathways that contribute to lung tissue damage. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512849-17-00Protocol code1305-0046Estimated enrolment400 patientsSponsorBoehringer Ingelheim Espana S.A.

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