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.
1initial 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.
2randomization 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.
3treatment 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.
4monitoring 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.
5completion 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 Study?
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 Study?
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.
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.
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.
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