A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of MBS2320 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This research study is looking into a new medication called MBS2320 for people living with Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition that causes scarring in the lungs, making it harder to breathe. The main goal of this study is to find out if MBS2320 can help improve lung function and slow down the disease, and if it is safe for patients to use. To do this, some participants will receive the new medicine, while others will be given a 'dummy' pill (a placebo) that looks the same but contains no active medicine. This allows researchers to compare the effects of MBS2320 against not taking the active drug. The study will look at how lung function changes over 12 weeks.
At a glance
What is this study about?
This study is a clinical trial, which is a special type of research designed to test new medicines safely. We are investigating a new drug called MBS2320 for people who have a lung condition called Idiopathic Pulmonary Fibrosis, often shortened to IPF. IPF causes the lungs to become scarred and stiff over time, making it increasingly difficult to breathe. Currently, there are treatments available for IPF, but doctors are always looking for new and better ways to manage the condition and improve patients' lives.
The main purpose of this study is to see if MBS2320 can help improve how well your lungs work and whether it is safe for people with IPF. To get a clear answer, some participants will receive MBS2320, while others will receive a placebo – a pill that looks identical but doesn't contain any active medicine. Neither you nor your study doctor will know which you are receiving, which helps ensure the results are unbiased. We will be closely monitoring changes in your breathing and overall health over 12 weeks.
Researchers will measure your lung function in various ways, such as how much air you can breathe out forcefully, and how much oxygen your lungs can absorb. We will also check your general health, how you feel day-to-day, and whether your condition gets worse. Comparing the groups who take MBS2320 and those who take the placebo will help us understand if MBS2320 is a promising new treatment that could help people with IPF in the future.
Key takeaways
- This study tests a new medicine (MBS2320) for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to see if the medicine improves lung function and is safe.
- Some participants will receive the active medicine; others will receive a dummy pill (placebo).
- Participation involves taking daily capsules and attending regular clinic visits for 12 weeks.
- Your medical care will not be affected if you choose not to join or decide to leave the study.
Who may be eligible?
To be able to take part in this study, you would need to be at least 18 years old. Both men and women are welcome to participate.
There will be other important health requirements to meet, which your study doctor will discuss with you. These are put in place to make sure the study is safe for you and to help the researchers get clear results. For example, you might need to have a specific diagnosis of IPF.
It's important to have an open conversation with your doctor about your complete medical history, including any other health problems you have or medications you are taking, to see if this study is right for you.
- Are you 18 years old or older?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
- Are you able to take daily oral medication (capsules)?
- Can you commit to regular clinic visits over 12 weeks?
- Are you open to potentially receiving a placebo (dummy pill) instead of the active medicine?
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, you would be asked to take a new medicine (or a dummy pill) every day for 12 weeks. You would have regular visits to the hospital or clinic, where the study team would check your health and how your lungs are working. These checks might include breathing tests, blood tests, and answering questions about how you are feeling. The study would last for 12 weeks, with follow-up appointments to make sure you are doing well. All these tests and medicines are provided at no cost, and you would be fully supported by the study team throughout your participation.
Potential risks and benefits
Locations (6)
- —France
- —Spain
- —Italy
- —Germany
- —Greece
- —Hungary
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a serious lung condition where the lungs become scarred, making it harder and harder to breathe over time.
What is the new medicine being tested?
The new medicine is called MBS2320. This study is trying to find out if it's safe and helps improve lung function in people with IPF.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers see if the new medicine really works better than no treatment.
How long would I be in the study?
You would be in the study for 12 weeks, taking the study medicine, and would have regular check-ups during that time.
Will I know if I'm getting the real medicine or the placebo?
Neither you nor your study doctor will know whether you are getting the active medicine or the placebo. This helps make the study results fair and accurate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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