Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) (AERIFY-1)
This important study is looking for volunteers with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) to test a new medicine called itepekimab. COPD can cause breathing difficulties, and sometimes these suddenly get worse, which we call a 'flare-up'. The main aim of the study is to find out if this new medicine can help reduce how often these flare-ups happen, and how severe they are. We will also be checking how itepekimab affects breathing ability, general lung health, and overall quality of life. As with all new medicines, a big part of the study is also to make sure it's safe and doesn’t cause too many unwanted side effects. Participants will be split into groups, with some receiving the new medicine and others receiving a 'dummy' medicine (placebo), so we can fairly compare the results.
At a glance
What is this study about?
Chronic Obstructive Pulmonary Disease (COPD) is a common lung condition that makes it difficult to breathe. It affects many people in the UK. One of the biggest challenges for people with COPD is experiencing sudden worsening of their symptoms, often called 'flare-ups' or 'exacerbations'. These flare-ups can be very serious, leading to hospital stays and can significantly impact daily life and overall health.
Researchers are always looking for new and better ways to help people living with COPD. This study is focused on a new medicine called itepekimab. It's designed to see if it can help reduce these problematic flare-ups. By comparing itepekimab to a 'dummy' medicine (placebo), the researchers can get a very clear picture of whether the new medicine is effective and truly making a difference for patients.
Beyond just looking at flare-ups, the study will also carefully check other important aspects of lung health. This includes measuring how well your lungs are working (using breathing tests), understanding how your daily life and breathing symptoms are affected, and very importantly, keeping a close eye on any side effects to make sure the medicine is safe. This thorough approach helps ensure that any new treatments are both effective and well-tolerated.
Key takeaways
- This study is testing a new medicine for moderate to severe COPD.
- The main goal is to see if it can reduce COPD flare-ups.
- Participants will receive either the new medicine or a dummy medicine.
- The study will also check breathing ability, lung health, and safety.
- It's open to adults aged 18 and over with COPD.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 years or older, with a diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study is open to both men and women.
There will be specific health checks and tests to make sure the study medicine is right for you and won't interfere with any other conditions or medications you might have. Not everyone with COPD will be suitable, as the study needs to focus on a particular group of patients to get the most accurate results.
The research team will discuss your medical history and current health in detail to see if you meet all the necessary requirements to participate safely in the trial.
- Are you 18 years old or older?
- Have you been diagnosed with moderate to severe COPD by a doctor?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially receive a dummy medicine?
- Are you comfortable with blood tests and breathing tests?
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'll be randomly assigned to either receive the study medicine, itepekimab, or a matched dummy medicine (placebo). Neither you nor the study team will know which one you are receiving – this is to ensure the results are as fair and unbiased as possible. You will then take this medicine regularly as instructed.
Your participation will involve a number of visits to the clinic over a period of time. During these visits, the study team will perform various assessments. This includes regular breathing tests (like blowing into a machine to measure your lung function), blood tests, checks of your heart's electrical activity (ECGs), and discussions about how you're feeling, any symptoms you have, and any side effects you might be experiencing. All these assessments help the researchers understand how the medicine is working and whether it's safe. You'll be closely monitored throughout the entire study period, and the team will be available to answer any questions or concerns you have.
Potential risks and benefits
Locations (8)
- —Romania
- —Slovakia
- —Bulgaria
- —Italy
- —Czechia
- —Poland
- —Hungary
- —Greece
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties.
What is a 'flare-up' in COPD?
A COPD flare-up, or exacerbation, is when your breathing symptoms suddenly get worse and may need extra treatment.
What does 'randomized, double-blind' mean?
It means you're put into a treatment group by chance, like flipping a coin, and neither you nor the doctors will know if you're getting the active medicine or the dummy medicine. This makes the study fair.
What is itepekimab?
Itepekimab is the name of the new medicine being tested in this study for people with COPD.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related medication and assessments will be provided.
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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