A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety and tolerability of different doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF).
This research is looking into a new medicine called BI 1819479 for people with idiopathic pulmonary fibrosis (IPF). IPF is a condition where your lungs become scarred and stiff, making it hard to breathe. The main goal of this study is to find out if this new medicine can help slow down the progress of IPF and improve or stabilise lung function. We also want to make sure it's safe and that people can tolerate taking it. Participants will be randomly given either the new medicine or a dummy pill (placebo). Neither you nor your study doctor will know which you are taking. We will carefully watch how your breathing changes over about a year by measuring your lung capacity. This study aims to find the most effective dose of the medicine.
At a glance
What is this study about?
This research study is focused on a health problem called idiopathic pulmonary fibrosis, or IPF. IPF is a type of lung disease where the lungs become scarred over time, making it harder and harder to breathe. We don't fully understand why it happens, which is why it's called 'idiopathic' (meaning a cause we don't know).
In this study, we are testing a new medicine, currently called BI 1819479. The main goal is to see if this medicine can help slow down the scarring in the lungs and make breathing easier for people with IPF. We also want to find out the best dose of the medicine and make sure it's safe for people to take. Think of it like trying out a new tool to see if it can fix a problem and how well it works.
To do this, we'll compare the new medicine with a 'placebo', which looks exactly like the actual medicine but doesn't contain any active drug. This allows us to see how much of a difference the new medicine truly makes, rather than improvements that might happen for other reasons. We will be carefully monitoring participants' lung function over many months to see if the medicine helps, primarily by measuring how much air you can breathe out after taking a deep breath (this is called FVC).
Key takeaways
- This study is testing a new medicine for idiopathic pulmonary fibrosis (IPF).
- It aims to see if the medicine can slow down lung scarring and improve breathing.
- Participants will take either the new medicine or a dummy pill (placebo) for up to a year.
- Lung function will be regularly checked using breathing tests.
- The study also focuses on finding the best dose and checking for safety.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. There's no upper age limit, so older adults can take part too. Both men and women are welcome to participate.
There will be other, more detailed health checks to make sure this study is safe and suitable for you. For example, the study team will need to confirm your diagnosis of idiopathic pulmonary fibrosis and check that your overall health allows you to take part. This is important to protect your safety and to ensure the study results are clear.
It's important to discuss your full medical history with the study doctor, as certain health conditions or medications might mean you can't join. They will explain everything clearly during your first visit.
- Are you 18 years old or older?
- Have you been diagnosed with idiopathic pulmonary fibrosis (IPF)?
- Are you willing to take study medication as a tablet?
- Are you able to attend regular clinic visits and have lung function tests?
- Are you willing to take part for up to about one year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be given study medication as a tablet that you'll take regularly. You will be assigned randomly to either receive the new medicine (BI 1819479) or a matching dummy pill (placebo). Neither you nor your study doctor will know which you are taking – this is to make sure the results are fair.
The study will last for at least 24 weeks, and could go on for up to 52 weeks, which is about a year. During this time, you will have several visits to the study clinic. At these visits, doctors and nurses will assess your health, take blood and other samples, and importantly, measure your lung function using a breathing test (called FVC). This test helps us see if the medicine is having an effect on your lungs. You'll also be asked about any side effects you might experience. After the treatment period, there will be follow-up appointments to check on your health.
Potential risks and benefits
Locations (14)
- —Norway
- —Germany
- —Italy
- —Austria
- —Finland
- —Poland
- —Hungary
- —Denmark
- —Belgium
- —Spain
- —France
- —Sweden
+2 more sites — see the official record for the full list.
Common questions
What is idiopathic pulmonary fibrosis (IPF)?
IPF is a serious lung condition where the lungs become scarred and stiff over time, making it hard to breathe. The cause isn't fully known.
What is BI 1819479?
BI 1819479 is a new medicine being tested in this study to see if it can help treat idiopathic pulmonary fibrosis.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers see the real effects of the new medicine.
How long will I be in the study?
The treatment part of the study will last for at least 24 weeks (about 6 months) and could be up to 52 weeks (about a year).
Will I know if I'm getting the active medicine or the placebo?
No, during the study, neither you nor your study doctor will know whether you are taking the active medicine or the placebo. This is to keep the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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