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Efficacy and Safety of BI 1015550 in Adults with Fibrosing Interstitial Lung Disease at Risk of Disease Progression: A Randomized, Placebo‑Controlled Trial

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What is this trial about?

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

The study focuses on people with fibrosing interstitial lung disease, a group of lung conditions where scar tissue builds up and makes breathing harder. The investigational medicine being tested is nerandomilast, an oral tablet taken each day. Some participants receive the active drug while others receive a placebo that looks the same.

The aim is to see whether nerandomilast can safely slow the decline in lung function compared with placebo. Participants are followed for at least 52 weeks; during that time they attend regular clinic visits where breathing tests are done, including measurement of forced vital capacity, which is the total amount of air exhaled after a deep breath, and a DLCO test that checks how well oxygen passes from the lungs into the blood. Lung images are also taken using high resolution computed tomography, a detailed scan that helps assess the amount of scarring. The study is double‑blind, meaning neither the participants nor the doctors know who receives the drug or the placebo, and participants are randomly assigned to each group.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessment

    You sign the informed consent form and complete the baseline assessments required for the study.

    Baseline assessments include a measurement of forced vital capacity (FVC) to evaluate lung function, a high‑resolution computed tomography (HRCT) scan to assess the extent of lung disease, and blood samples for safety laboratory tests.

    These measurements establish your starting point for later comparison.

  2. Step 2

    Randomization and Study Medication Assignment

    The study staff randomly assign you to receive either nerandomilast tablets or matching placebo tablets.

    The trial is double‑blind, meaning that neither you nor the study staff know which medication you are receiving.

  3. Step 3

    Start of Study Medication

    You begin taking one oral tablet each day as instructed.

    Each tablet contains the study dose of nerandomilast (or identical placebo) as defined by the trial protocol.

    You continue this daily dosing for at least 52 weeks unless you stop early for safety reasons.

  4. Step 4

    Regular Clinic Visits

    You attend scheduled clinic visits at approximately weeks 4, 12, 24, 36, and 52 after starting the medication.

    During each visit, lung function is measured again, including FVC and diffusing capacity for carbon monoxide (DLCO), and you are asked about any side effects or new symptoms.

    Blood samples may be taken at each visit to monitor safety.

    At the week 52 visit, a repeat HRCT scan is performed to evaluate changes in disease extent.

  5. Step 5

    Ongoing Safety Monitoring

    Throughout the trial you are instructed to report any new symptoms, adverse events, or concerns to the study team promptly.

    The study team reviews safety data at each visit and may adjust or discontinue the medication if safety concerns arise.

  6. Step 6

    End‑of‑Study Assessment

    After completing at least 52 weeks of treatment, you undergo final assessments similar to the baseline visit.

    Final assessments include measurements of FVC, DLCO, a repeat HRCT scan, and a comprehensive safety evaluation.

    The study medication is then stopped.

  7. Step 7

    Post‑Study Follow‑Up

    After the end‑of‑study visit, you may have a follow‑up contact (phone call or clinic visit) to check for any late‑onset effects, as described in the trial protocol.

Who can join the trial?

9 criteria

  • Be at least 18 years old when you sign the consent form.
  • Sign a written consent form that shows you understand the study and agree to take part.
  • Have a doctor’s diagnosis of a fibrosing interstitial lung disease (ILD) that is not idiopathic pulmonary fibrosis (IPF). (These are conditions where the lung tissue becomes scarred.)
  • Show signs of lung scarring on a special scan called a high resolution CT (HRCT). The scan must reveal patterns such as a net‑like appearance (reticulation), small airway widening (traction bronchiectasis or bronchiolectasis), or honey‑comb‑like areas, affecting at least 10% of the lungs.
  • Have been diagnosed with the lung disease no more than 3 years before the study starts.
  • Have a forced vital capacity (FVC) that is at least 45 % of the normal value predicted for someone of your age, sex, and size. (FVC measures how much air you can exhale forcefully.)
  • Have a diffusing capacity of the lungs for carbon monoxide (DLCO) that is at least 25 % of the normal value, adjusted for your blood’s hemoglobin level. (DLCO measures how well oxygen moves from your lungs into your blood.)
  • If you are taking medicines that suppress or modify the immune system (such as methotrexate or azathioprine), you must have been on a stable dose for at least 12 weeks before the first study visit and continue the same dose during the screening period.
  • Meet any other study requirements that are listed in the full protocol.

Who cannot join the trial?

9 criteria

  • If you have been diagnosed with idiopathic pulmonary fibrosis (IPF) – a type of lung scarring disease – by a team of specialists following official guidelines, you cannot join.
  • If you have a lung disease caused by an autoimmune condition (other than rheumatoid arthritis‑related lung disease), you cannot join.
  • If you have been diagnosed with sarcoidosis, a disease that forms small inflammatory lumps in organs such as the lungs, you cannot join.
  • If a detailed lung scan called a high‑resolution CT (HRCT) shows mainly signs of organizing pneumonia, you cannot join.
  • If your lung scarring (interstitial lung disease) started after a COVID‑19 infection, you cannot join.
  • If your doctor determines that you meet the criteria for progressive pulmonary fibrosis (PPF) – meaning the disease is getting worse over time – you cannot join.
  • If you are already being treated with medicines that are approved for fibrosing interstitial lung disease (such as those used for PPF), you cannot join.
  • If you have taken or are currently taking nerandomilast, nintedanib, or pirfenidone – drugs used to treat lung scarring – you cannot join.
  • Other additional reasons may also prevent participation.
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Investigated drugs

BI 1015550 is an experimental oral medication that is being tested to see if it can help slow the loss of lung function in people with fibrosing interstitial lung disease. In the study, participants take the drug in a film‑coated tablet form. Researchers will compare how well this medication works against a placebo to determine if it can reduce the decline in forced vital capacity (the amount of air a person can exhale forcefully) over at least 52 weeks.

What is already known about the treatment

nerandomilast - It is taken as an oral film‑coated tablet that patients swallow with water. The drug is still experimental and is being studied in several clinical trials for lung scarring conditions. It is intended to treat fibrosing interstitial lung diseases by blocking an enzyme that causes inflammation and tissue thickening. It belongs to the class of phosphodiesterase‑4 inhibitors, which reduce inflammatory signals in the body. BI 1015550 - This medication is also given as an oral film‑coated tablet that is swallowed whole. It is an investigational drug currently in late‑stage clinical testing for diseases that cause lung scarring. It works by inhibiting a specific protein kinase that drives the growth of fibrous tissue in the lungs. It is classified as a small‑molecule kinase inhibitor.

Investigated diseases

  • Interstitial lung disease

    A group of conditions that cause inflammation and scarring of the lung tissue. The scarring makes the lungs stiff, which reduces the amount of air they can hold. Over time, breathing becomes more difficult as the lung’s ability to exchange oxygen and carbon dioxide declines. The disease can develop slowly or more rapidly, depending on the underlying cause. Symptoms often start with a dry cough and shortness of breath that gradually worsen.

  • Fibrosing interstitial lung disease (non‑IPF)

    A type of interstitial lung disease in which scar tissue forms in the lungs but does not meet the criteria for idiopathic pulmonary fibrosis. The fibrosis can spread within the lungs, leading to a steady loss of lung capacity. Patients may notice increasing shortness of breath during everyday activities. The condition can evolve toward a pattern of progressive pulmonary fibrosis, where lung function continues to decline. Regular monitoring of breathing ability and lung imaging helps track its course.

Trial detailsLast updated 23 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526028-38-00Protocol code1305-0152Estimated enrolment407 patientsSponsorBoehringer Ingelheim Espana S.A.

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