A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
This study, called a Phase III trial, is looking at a new drug named BI 1015550 for people with progressive fibrosing interstitial lung diseases (PF-ILDs). These conditions cause scarring in the lungs, making it harder to breathe over time. The main goal is to check if BI 1015550 can improve how well your lungs work, specifically by measuring your Forced Vital Capacity (FVC) over 52 weeks (about one year). Researchers also want to make sure the drug is safe. Some participants will receive the new drug, while others will get a placebo (a dummy drug) to compare the results fairly. This approach helps us understand if the new drug truly makes a difference.
At a glance
What is this study about?
This clinical trial is investigating a new medication called BI 1015550 for people who have been diagnosed with progressive fibrosing interstitial lung diseases, often shortened to PF-ILDs. These are a group of conditions where the tissue in your lungs becomes scarred and thickens over time, making it increasingly difficult to breathe. The word 'progressive' means that the condition tends to get worse, and 'fibrosing' refers to this scarring process.
The main aim of this study is to find out if BI 1015550 can help improve or at least stabilise lung function for people with PF-ILDs, and to make sure it's safe to use. Lung function is often measured by something called Forced Vital Capacity (FVC), which is the total amount of air you can breathe out forcefully after taking a deep breath in. The researchers will be looking to see how this measure changes after about a year (52 weeks) of treatment.
Studying new medicines like this is really important because it helps doctors find better ways to treat serious lung conditions. If BI 1015550 proves to be effective and safe, it could offer a new treatment option to help people with PF-ILDs manage their condition and improve their quality of life.
Key takeaways
- This study is for people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs).
- It's testing a new drug called BI 1015550.
- The main goal is to see if the drug improves lung function and is safe.
- Participation involves regular clinic visits and health checks over about a year.
- You might receive the new drug or a dummy drug (placebo).
Who may be eligible?
To join this study, people with progressive fibrosing interstitial lung diseases (PF-ILDs) of all adult ages and genders are generally welcome to participate. The study aims to include a broad range of people diagnosed with these conditions.
However, there will be specific medical criteria that need to be met, and other health conditions or medications might mean someone isn't suitable for the study. This is to ensure the safety of participants and the accuracy of the trial results.
Your doctor will discuss all the detailed requirements with you to see if this study is a good fit for your individual health situation.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have been diagnosed with a Progressive Fibrosing Interstitial Lung Disease (PF-ILD).
- I am an adult.
- I am able to attend regular clinic visits for about a year.
- I am willing to take either a new study drug or a placebo.
What does participation involve?
If you decide to take part in this study, you would be assigned to either receive the new drug, BI 1015550, or a 'placebo', which looks exactly like the drug but contains no active medicine. Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' approach and helps ensure fairness in the results. The treatment will last for at least 52 weeks, which is about one year, but could go on for longer depending on the study plan.
During this time, you would have regular visits to the clinic for various check-ups. These would likely include breathing tests, blood tests, and possibly other scans or assessments to monitor your lung function and general health. You would also be asked about any symptoms you're experiencing, such as breathlessness or cough, to see how these might change over time. There will be careful monitoring for any side effects you might experience from the medication. The total duration of your involvement could extend beyond the 52 weeks of treatment to include follow-up appointments.
Potential risks and benefits
Locations (19)
- —UnverifiedNetherlands
- —UnverifiedGreece
- —UnverifiedSlovenia
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedFinland
- —UnverifiedCroatia
- —UnverifiedCzechia
Common questions
What are Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)?
These are lung conditions where scarring and thickening happen in the lung tissue, making it harder to breathe and often getting worse over time.
What is BI 1015550?
It's a new medication being tested to see if it can help improve lung function and is safe for people with PF-ILDs.
What is a 'placebo'?
A placebo looks just like the real medicine but doesn't have any active drug in it. It's used in studies to fairly compare the new medicine's effects.
How long will the study last?
The main treatment period is at least 52 weeks (about one year), but your total involvement might be longer with follow-up appointments.
Will I know if I'm getting the drug or the placebo?
No, it's a 'double-blind' study, meaning neither you nor your doctor will know if you're receiving the active drug or the placebo until the study ends.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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