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Safety, Pharmacokinetics, and Exploratory Efficacy of BI 1015550 and Nerandomilast in Children and Adolescents Aged 2‑17 Years With Fibrosing Interstitial Lung Disease

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What is this trial about?

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

The trial looks at children and adolescents with fibrosing interstitial lung disease, a condition where scar tissue builds up in the lungs and makes breathing difficult. The medication being tested is called nerandomilast, given as a film‑coated tablet taken by mouth. A group will receive the active drug while another group will receive a placebo, which looks the same but contains no active ingredient. The main aim is to find out how the drug is handled by the body and whether it is safe for this age group.

Participants will be divided by age. Those aged 6 to under 18 will be part of a double‑blind phase where neither the participants nor the doctors know who receives the drug or the placebo, followed by an open‑label phase where everyone receives the active medication. Children younger than 6 will start directly with the active drug in an open‑label part. Over the course of the study, researchers will watch for side effects and will measure simple health indicators such as oxygen saturation (SpO2), lung capacity measured as FVC, and the distance walked in six minutes (6‑min walk distance), as well as growth and quality‑of‑life questionnaires.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After you sign the consent form, you receive a study identification number.

    Baseline measurements are taken, including medical history, lung function tests, height, weight, oxygen saturation on room air, and a quality‑of‑life questionnaire.

  2. Step 2

    Randomization

    If you are between 6 and less than 18 years old, you enter a double‑blind phase where you will receive either nerandomilast or a placebo tablet, and you will not know which one you are taking.

    If you are between 2 and less than 6 years old, you are placed directly in an open‑label phase and will receive nerandomilast from the start.

  3. Step 3

    Medication administration during part a

    You take an oral film‑coated tablet once daily as instructed by the study team.

    The tablet contains nerandomilast (or placebo for the double‑blind group) at a dose of 00 mg.

    The tablet is swallowed with water and should be taken at the same time each day.

  4. Step 4

    Early safety and exposure check (week 2)

    At week 2 you attend a study visit for blood sampling.

    Participants aged 6 years and older provide a rich sampling set, while younger participants provide a sparse sampling set.

    The visit also includes a check for any treatment‑emergent adverse events and a review of your oxygen saturation and height.

  5. Step 5

    Regular monitoring visits

    Throughout part a you attend scheduled visits to report any side effects, have your oxygen saturation measured, and confirm that you are taking the tablet as directed.

    The study team may also assess the acceptability of the tablet size and the use of a dispenser at week 2 and week 26.

  6. Step 6

    Mid‑study assessment (week 26)

    At week 26 a comprehensive evaluation is performed.

    Measurements include oxygen saturation on room air, height, a quality‑of‑life questionnaire, and a review of any adverse events that occurred up to this point.

    For participants 6 years and older, lung function (forced vital capacity) and a 6‑minute walk distance may also be measured.

  7. Step 7

    Transition to part b (open‑label active treatment)

    After week 26 all participants, regardless of previous group, receive open‑label nerandomilast tablets.

    The same daily dose of 00 mg is continued.

    The purpose of part b is to collect additional safety and exposure data up to week 52.

  8. Step 8

    Early exposure check in part b (week 28)

    At week 28 a blood sampling visit is performed for participants 6 years and older to assess drug exposure at steady state.

  9. Step 9

    Final assessment (week 52)

    At week 52 a final evaluation is conducted.

    The same measurements as at week 26 are repeated: oxygen saturation, height, quality‑of‑life questionnaire, and for eligible participants lung function and 6‑minute walk distance.

    All adverse events that occurred during the entire trial are recorded.

  10. Step 10

    Completion of trial participation

    After the week 52 visit, study medication is stopped and data collection is finished.

    You are thanked for your contribution and any remaining study supplies are returned as instructed.

Who can join the trial?

8 criteria

  • Be between 2 years old and younger than 18 years old at the time of the second study visit.
  • Have evidence of fibrosing interstitial lung disease (a type of lung scarring) shown on a high‑resolution CT scan (HRCT) within the past 12 months, confirmed by the study doctors.
  • If you are 6 years old or older, your lung function test called forced vital capacity (FVC) % predicted must be at least 25% of the normal value expected for someone your age, height, and gender.
  • Show signs of clinically significant disease at the second visit, meaning the doctor sees any of the following:
    • A Fan score of 3 or higher (a rating that measures how much scarring is seen on imaging).
    • Documented evidence that the disease is getting worse, such as:
      • A 5‑10% drop in FVC % predicted together with worsening symptoms.
      • A drop of 10% or more in FVC % predicted.
      • Increased scarring (fibrosis) seen on the HRCT scan.
      • Other signs of worsening lung disease, for example needing more supplemental oxygen or having a lower diffusion capacity (the ability of the lungs to move oxygen into the blood).

Who cannot join the trial?

9 criteria

  • Having taken nerandomilast before the study.
  • Having taken other oral or systemic PDE4 or non‑selective PDE inhibitor medicines within 30 days before the first visit (these are drugs that block certain enzymes in the body).
  • Having taken pirfenidone within the 8 weeks before the first visit (pirfenidone is a medication used to treat lung scarring).
  • Having unstable pulmonary arterial hypertension (PAH), which means high blood pressure in the lung arteries that is not well controlled.
  • Having active vasculitis that is unstable or not under control within 8 weeks before the first visit or during screening (vasculitis is inflammation of the blood vessels).
  • Having any history of suicidal behaviour at any time in life, including attempts, interrupted attempts, aborted attempts, or preparation for an attempt.
  • Having serious suicidal thoughts of type 4 or 5 on the C‑SSRS questionnaire in the past 3 months at the first or second visit (type 4 or 5 means thinking about suicide with a method and intent, with or without a specific plan).
  • Having significant depression symptoms, shown by a score of 8 or higher on the short mood questionnaire called the SMFQ (a brief survey that measures mood and feelings).
  • Other exclusion reasons not listed here may also prevent participation.
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Investigated drugs

  • BI 1015550

    is an experimental oral tablet that is being tested in the study to see how the body absorbs it and whether it is safe for children and adolescents. Participants take the tablet by mouth, and researchers monitor how the drug behaves in the body and look for any side effects. This medication is part of the trial’s effort to explore new treatments for lung diseases that cause scarring.

  • NERANDOMILAST

    is another experimental oral tablet being studied as a possible treatment for fibrosing interstitial lung disease in children and teenagers. In the trial, participants swallow the tablet, and the researchers evaluate different dose levels to understand how much of the drug the body receives, how safe it is, and whether it might help improve lung function. This medication is the main focus of the study’s investigation into new options for young patients with this serious lung condition.

What is already known about the treatment

BI 1015550 - This medication is taken as a film‑coated tablet by mouth. It is still an experimental drug and has only been reported in early‑phase clinical studies for lung scarring conditions. It is being investigated mainly for fibrosing interstitial lung disease, where it may help slow the formation of scar tissue in the lungs. It works by blocking an enzyme called phosphodiesterase‑4, which reduces signals that cause inflammation and fibrosis, and it is classified as a selective phosphodiesterase‑4 inhibitor. Nerandomilast - This drug is also given as a film‑coated tablet taken orally. It is a new investigational medicine that has appeared in recent clinical trial reports but is not yet approved for any disease. The main use being studied is fibrosing interstitial lung disease in children, where it may lessen lung inflammation and scarring. Its action involves inhibiting phosphodiesterase‑4, which lowers inflammatory signals, and it belongs to the class of selective phosphodiesterase‑4 inhibitors.

Investigated diseases

Fibrosing interstitial lung disease - Fibrosing interstitial lung disease is a group of conditions where the tissue surrounding the air sacs of the lungs becomes thickened and scarred. This scarring makes the lungs less flexible and reduces their ability to expand fully. Over time the scar tissue can spread, leading to a gradual decline in breathing efficiency. People may notice increasing shortness of breath, especially during activity, and a persistent dry cough. The disease often progresses slowly, but the rate can vary between individuals.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523369-32-00Protocol code1305-0022Estimated enrolment41 patientsSponsorBoehringer Ingelheim Espana S.A.

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