A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
This study is for adults aged 40 and over who have a lung condition called Idiopathic Pulmonary Fibrosis (IPF). We want to find out if a new medicine, called BI 765423, can help improve how well their lungs work. Half of the participants will receive the new medicine, and the other half will receive a 'dummy' medicine (placebo) that looks the same but contains no active drug. The medicine is given into a vein every four weeks. We'll compare lung function after three months and check for other improvements in lung health. Participants will be in the study for about 8 to 10 months and can continue their usual IPF treatment. Regular visits will involve lung tests and blood samples, with doctors monitoring health and any side effects.
At a glance
What is this study about?
This study is about a lung disease called Idiopathic Pulmonary Fibrosis, or IPF for short. IPF is a condition where scar tissue builds up in the lungs, making it harder to breathe over time. We are testing a new medicine, called BI 765423, to see if it can help people with IPF. The main goal is to find out if this medicine can make a difference in how well the lungs work.
To do this, we will compare the new medicine with a 'placebo'. A placebo looks exactly like the actual medicine but doesn’t contain any active drug. This helps us understand if any changes are truly due to the new medicine or if they might happen anyway. We will regularly check lung function and other health markers during the study to see if there's a difference between those who receive the medicine and those who receive the placebo.
Understanding whether BI 765423 can improve lung health is very important. If successful, this medicine could offer a new way to help people living with IPF. We are carefully studying its effects and making sure it is safe for participants.
Key takeaways
- This study evaluates a new medicine (BI 765423) for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to see if the medicine improves lung function.
- Participants will receive either the active medicine or a placebo, given monthly by infusion.
- The study lasts 8-10 months, with regular health checks and lung tests.
- You can continue your usual IPF treatment during the study.
Who may be eligible?
This study is looking for adults who are at least 40 years old. To join, you must have received a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) from your doctor.
Your most recent lung scan (CT scan) needs to show a specific pattern in your lungs that is typical for IPF. Also, your current lung function, measured by a test called Forced Vital Capacity (FVC), needs to be at least 45% of what's expected for someone of your age and size.
For women, you can join if you are past menopause or have had certain surgeries that prevent you from becoming pregnant. Men can join, but if your partner could become pregnant, you'll need to use contraception during the study.
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.
- Are you 40 years old or older?
- Do you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
- Has your doctor confirmed your IPF diagnosis based on recent guidelines and a CT scan?
- Is your lung function (FVC) at least 45% of what's expected for you?
- If you are a woman, are you past menopause or unable to become pregnant?
What does participation involve?
If you decide to join this study, your journey will last about 8 to 10 months. During this time, you will visit the study site several times. The first few visits are to check if the study is right for you, followed by treatment visits, and then a follow-up visit after your treatment ends.
You will be randomly placed into one of two groups: one group will receive the new medicine, BI 765423, and the other will receive the placebo. The medicine (or placebo) is given through a drip into a vein every four weeks. You can usually continue taking your current IPF medicines while in the study.
Throughout the study, doctors will regularly check your health. This includes measuring your lung function, taking blood samples, and asking about any side effects you might experience. These checks help us understand how the medicine is working and keep you safe.
Potential risks and benefits
Locations (46)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- University of FloridaVerified postcodeGainesville, United States· Not yet recruiting
- Renstar Medical ResearchVerified postcodeOcala, United States· Recruiting
- University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States· Not yet recruiting
- University of Kansas Medical CenterVerified postcodeKansas City, United States· Not yet recruiting
- University of MinnesotaVerified postcodeMinneapolis, United States· Not yet recruiting
- The Lung Research Center, LLCVerified postcodeChesterfield, United States· Recruiting
- University of Missouri Health SystemVerified postcodeColumbia, United States· Not yet recruiting
- Columbia University Medical Center-New York Presbyterian HospitalVerified postcodeNew York, United States· Recruiting
- Weill Cornell Medical CollegeVerified postcodeNew York, United States· Not yet recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Not yet recruiting
- University of Cincinnati Medical CenterVerified postcodeCincinnati, United States· Not yet recruiting
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease where scar tissue forms in the lungs, making it hard to breathe.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps compare the new medicine's effects.
How is the study medicine given?
The medicine or placebo is given as a drip into a vein every four weeks.
Can I continue my regular IPF treatment?
Yes, you can usually continue your standard IPF treatment while participating in the study.
How long will I be in the study?
The study lasts for approximately 8 to 10 months, including screening, treatment, and follow-up.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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