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Long-Term Study of BI 1015550 for Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

Verified siteInvestigationalNo 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 the long-term effects of a medication called BI 1015550 in people with two types of lung diseases: idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). These conditions cause scarring in the lungs, making it difficult to breathe. The medication being tested is taken as a film-coated tablet by mouth.

The purpose of this study is to understand how well BI 1015550 works over a long period and to check its safety in patients who have already participated in previous studies with this medication. Participants will continue taking the medication as they did in the earlier trials, and the study will monitor them for any side effects or changes in their condition. The study will last for about 99 weeks, during which time participants will have regular check-ups to assess their health and the medication's effects.

This trial does not involve comparing BI 1015550 with other treatments or a placebo. Instead, it focuses on observing the experiences of those taking the medication. The study aims to gather information on any adverse events and changes in lung function over time, helping to determine the long-term benefits and risks of using BI 1015550 for treating IPF and PPF.

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

    Joining the study

    Participation begins after completing treatment in previous trials without stopping early.

    Written informed consent is required before starting the trial.

  2. Step 2

    Medication administration

    The medication used is BI 1015550, taken as a film-coated tablet.

    The route of administration is oral.

  3. Step 3

    Treatment duration

    The trial is designed to assess long-term treatment, continuing until the end of the study visit planned at week 99.

  4. Step 4

    Monitoring and assessments

    The primary focus is on monitoring any adverse events throughout the trial.

    Secondary assessments include changes in lung function and time to significant health events related to pulmonary fibrosis.

  5. Step 5

    End of study

    The study is expected to conclude by June 16, 2027.

    Final assessments will be conducted at the end of the study period.

Who can join the trial?

4 criteria

  • Patients must have completed treatment in the previous trials (1305-0014 or 1305-0023) without stopping the treatment early, unless it was a temporary break.
  • Patients need to sign a written consent form, which means they agree to participate in the study and understand what it involves.
  • Women of childbearing potential must use very effective birth control methods to prevent pregnancy. This means using methods that have a low chance of failing if used correctly. If they are taking birth control pills, they should also use a barrier method like a condom during sex, especially if they experience severe vomiting or diarrhea, which can make the pills less effective.
  • In France, men who can father children must also use acceptable birth control methods.

Who cannot join the trial?

2 criteria

  • Patients who have not completed the planned treatment in the previous related trials.
  • Patients who stopped taking the trial medication early in the previous related trials.
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Investigated drugs

BI 1015550 is an oral medication being studied for its long-term safety and effectiveness in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). This trial aims to understand how well patients tolerate the medication over an extended period and to monitor any side effects that may occur. The study is focused on patients who have already completed previous treatment phases without stopping the medication early.

What is already known about the treatment

BI 1015550 – This medication is administered orally and is currently being studied in clinical trials for its long-term safety and effectiveness in treating idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is in the investigational stage, with ongoing research to evaluate its tolerability and potential benefits. The main therapeutic use of BI 1015550 is to manage and treat IPF and PPF, conditions characterized by progressive scarring of lung tissue. At the molecular level, it works by targeting specific pathways involved in fibrosis, potentially slowing down or halting the progression of lung tissue damage. It is classified pharmacologically as an anti-fibrotic agent.

Investigated diseases

  • Progressive Pulmonary Fibrosis (PPF)

    Progressive pulmonary fibrosis is a condition characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. This scarring makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. As the disease progresses, patients may experience worsening shortness of breath and a persistent dry cough. The exact cause of the fibrosis can vary, and it may be associated with other underlying conditions. The progression of the disease can vary significantly among individuals, with some experiencing a more rapid decline in lung function than others.

  • Idiopathic Pulmonary Fibrosis (IPF)

    Idiopathic pulmonary fibrosis is a specific type of progressive lung disease where the cause of the fibrosis is unknown. It is characterized by the thickening and stiffening of lung tissue due to the formation of scar tissue. This scarring leads to a gradual decline in lung function, making it difficult for patients to breathe deeply. Over time, individuals with IPF may experience increasing shortness of breath and a persistent dry cough. The progression of the disease can vary, with some patients experiencing a slow decline while others may have a more rapid progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507353-15-00Protocol code1305-0031Estimated enrolment1 828 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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