Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on BI 1015550 for Improving Lung Function in Patients with Progressive Fibrosing Interstitial Lung Diseases

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 lung diseases known as Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). These diseases cause scarring of the lung tissue, which can lead to breathing difficulties. The trial is testing a new treatment called BI 1015550, which is taken as a film-coated tablet. The purpose of the study is to see if BI 1015550 can help improve lung function in people with these conditions.

Participants in the study will be randomly assigned to receive either the BI 1015550 treatment or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for at least 52 weeks, during which time the effects of the treatment on lung function will be closely monitored. The main goal is to see if BI 1015550 can slow down the decline in lung function compared to the placebo.

Throughout the study, participants will have regular check-ups to assess their lung function and overall health. The trial will also look at other important outcomes, such as the time it takes for any worsening of the lung disease, hospitalizations due to breathing problems, or any other serious health events. This research aims to provide valuable information on the safety and effectiveness of BI 1015550 for people living with Progressive Fibrosing Interstitial Lung Diseases.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of progressive fibrosing interstitial lung diseases (PF-ILDs), and other health criteria.

    The assessment ensures that the patient has a forced vital capacity (FVC) of at least 45% of the predicted normal value and a diffusing capacity for carbon monoxide (DLCO) of at least 25% of the predicted normal value.

  2. Step 2

    Randomization and treatment allocation

    Patients are randomly assigned to receive either the study medication BI 1015550 or a placebo. Both are administered as film-coated tablets for oral use.

    The study medication aims to evaluate its effectiveness in reducing lung function decline compared to the placebo.

  3. Step 3

    Treatment phase

    The treatment phase lasts for at least 52 weeks. During this period, patients take the assigned medication regularly as instructed.

    The primary goal is to observe any changes in lung function, specifically the absolute change from baseline in FVC at week 52.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to track the patient's health and any side effects. This includes measuring lung function and other health parameters.

    Secondary endpoints include time to first acute ILD exacerbation, hospitalization for respiratory causes, or death, among other health outcomes.

  5. Step 5

    Completion and final assessment

    At the end of the 52-week period, a final assessment is conducted to evaluate the overall impact of the treatment on lung function and other health indicators.

    The study aims to determine the efficacy and safety of BI 1015550 in improving lung function in patients with PF-ILDs.

Who can join the trial?

8 criteria

  • Patients must be **18 years or older** at the time they sign the consent form.
  • Must have signed and dated a written consent form before joining the trial, following local rules and guidelines.
  • Must have a diagnosis of **progressive fibrosing interstitial lung disease (ILD)**, confirmed by a doctor, but not idiopathic pulmonary fibrosis (IPF).
  • Patients can either be on a stable treatment with **nintedanib** for at least 12 weeks before the first visit and during the screening, or not be on nintedanib for at least 8 weeks before the first visit and during the screening period. They should not plan to start or restart antifibrotic treatment.
  • **Forced Vital Capacity (FVC)**, which is a measure of lung function, must be at least 45% of what is predicted as normal at the first visit.
  • **DLCO**, a test that measures how well the lungs transfer gas, corrected for hemoglobin, must be at least 25% of the predicted normal at the first visit.
  • Women who can have children must be willing and able to use highly effective birth control methods. If they are taking oral contraceptives, they must also use a barrier method.
  • Patients using certain allowed medications that suppress the immune system (other than corticosteroids) for another disease must be on a stable treatment for at least 12 weeks before the first visit and during the screening period.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of lung disease that is not classified as Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs).
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse that might affect their ability to participate in the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

BI 1015550 is a medication being studied for its potential to slow down the decline in lung function in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). The trial aims to assess how effective and safe this medication is over a period of at least 52 weeks. The main goal is to see if it can reduce the worsening of lung function compared to not receiving the active treatment.

What is already known about the treatment

BI 1015550 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for BI 1015550 is to slow down the decline in lung function in patients with PF-ILDs. At the molecular level, it works by targeting specific pathways involved in lung tissue fibrosis, aiming to reduce the progression of the disease. BI 1015550 is classified pharmacologically as an anti-fibrotic agent.

Investigated diseases

Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) – These are a group of lung disorders characterized by progressive scarring of lung tissue, which leads to a decline in lung function over time. The scarring, or fibrosis, makes it difficult for the lungs to work properly, causing symptoms such as shortness of breath and a persistent cough. As the disease progresses, the lung tissue becomes increasingly stiff, reducing the ability to transfer oxygen into the bloodstream. This can lead to a decrease in physical activity levels and overall quality of life. The progression of the disease varies among individuals, with some experiencing a rapid decline in lung function, while others may have a slower progression.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-512803-37-00Protocol code1305-0023Estimated enrolment1 178 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).