A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
This research study, called BEACON-IPF, is investigating a new medication, bexotegrast, for people living with idiopathic pulmonary fibrosis (IPF). IPF is a condition that causes scarring of the lungs, making it harder to breathe. The study wants to find out if bexotegrast can improve how well your lungs work and help slow down the progression of the disease. It also aims to check if the medicine is safe and what side effects it might have. Participants will be randomly given either the new medicine or a dummy pill (placebo) that looks the same. Doctors will monitor lung function, symptoms like breathlessness and cough, and overall health over about a year.
At a glance
What is this study about?
Idiopathic pulmonary fibrosis, or IPF, is a serious lung condition where scar tissue builds up in your lungs. This scarring makes your lungs stiff and less able to take in oxygen, leading to symptoms like shortness of breath and a persistent cough. Treatments available today can help slow the disease down, but there's still a need for new and more effective options.
This study is testing a new drug called bexotegrast. Researchers believe this medicine might work by targeting specific processes in the body that lead to lung scarring. The main goal is to see if bexotegrast can improve how much air your lungs can hold, which is a key measure of lung function, over a period of 52 weeks (about one year).
Beyond lung function, the study will also look at other important aspects. This includes how long it takes for the disease to get worse, how often people need to go to hospital for breathing problems, changes in cough and breathlessness, and how it affects their quality of life. By looking at all these factors, the study hopes to get a full picture of whether bexotegrast is a helpful and safe treatment for IPF.
Key takeaways
- This study is testing a new drug (bexotegrast) for IPF.
- It aims to see if the drug improves lung function and slows disease progression.
- Participants will receive either the active drug or a dummy pill.
- The study will last about one year, with regular clinic visits.
- It will also check for safety and side effects of the new medicine.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older.
Both men and women can take part in this research. The study will also have other specific requirements related to your specific health history and current medical conditions, which the study doctors will discuss in detail with you.
It's important that your doctor carefully reviews your medical notes to ensure this study is a good and safe fit for you. Not everyone with IPF will be able to join, as certain health conditions or medications might affect your eligibility.
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 18 years old or older?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
- Are you able to attend regular clinic appointments for about a year?
- Are you willing to potentially receive a dummy pill instead of the study drug?
What does participation involve?
If you decide to take part, you'll be randomly assigned to either receive the new medicine, bexotegrast, or a matching dummy pill (placebo). You won't know which one you're getting, and neither will your study doctor. This is to ensure fair results. The study will last for about 52 weeks (one year).
Throughout the study, you'll have regular visits to the clinic. These visits will involve blood tests, physical examinations, and lung function assessments, such as measuring your forced vital capacity (FVC), which shows how much air you can breathe out after taking a deep breath. You'll also be asked to complete questionnaires about your symptoms like breathlessness and cough, and how your overall health and daily life are affected.
There will be follow-up calls or visits to monitor your health and any side effects you might experience. All these assessments help the researchers understand how the medicine is working and whether it is safe.
Potential risks and benefits
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Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung condition where scar tissue builds up in your lungs, making them stiff and gradually harder to breathe. 'Idiopathic' means the cause is unknown.
What is bexotegrast?
Bexotegrast is a new medicine being tested to see if it can help treat IPF by reducing lung scarring and improving lung function.
What does 'randomized, double-blind, placebo-controlled' mean?
It means you'll be randomly assigned to either the active medicine or a dummy pill (placebo). Neither you nor your doctor will know which you're receiving. This helps ensure fair and unbiased results.
How long will the study last?
The main part of this study will last for about 52 weeks, which is roughly one year. There might be follow-up observations after that.
Will I have to pay to participate?
No, you will not have to pay to participate in the study, and all study-related treatments and tests will be provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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