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(352) 733-0111

1305-0014 (FIBRONEERTM IPF)

  • Status
    Accepting Candidates
  • Age
    40 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Details

Full study title A Double Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Protocol number OCR42810
ClinicalTrials.gov ID NCT05321069
Phase Phase 3

Eligibility

Inclusion criteria

  1. Patients ≥40 years old at the time of signed informed consent.

  2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

  3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

  4. Patients may be either:

    • on a stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.)

    • not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

  5. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.

  6. Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1

  7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method

Exclusion criteria

  1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1. /Forced vital capacity (FVC)

Lead researchers

  • Christopher Harden, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
  • Divya C Patel, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
    Divya C Patel

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.