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)
This research study is for people with a lung condition called Chronic Obstructive Pulmonary Disease (COPD) that is moderate to severe. We are testing a new medication called itepekimab. The main goal is to find out if this new drug can lower the number of moderate or severe COPD flare-ups people experience each year, especially in those who used to smoke. We also want to see if it improves how well their lungs work and their overall quality of life. Participants will be given either the new drug or a dummy treatment (placebo) to fairly compare their effects. This is a common way to test new medicines to make sure they are both safe and effective. While the study focuses on former smokers, some information will also be gathered from current smokers.
At a glance
What is this study about?
This important study is designed to learn more about a new medicine, called itepekimab, for people living with moderate to severe Chronic Obstructive Pulmonary Disease, or COPD. COPD is a long-term lung condition that makes it hard to breathe.
We want to see if itepekimab can help reduce what doctors call 'exacerbations.' These are times when your COPD symptoms suddenly get much worse, often requiring extra treatment. The study will also check if the new medicine helps improve your lung function – that is, how well your lungs are working – and how you feel in your everyday life. To make sure the results are fair, some participants will receive the new medicine, while others will receive a 'placebo,' which looks like the real medicine but contains no active drug. This allows us to compare the effects accurately.
This type of study, called a Phase 3 trial, is usually the last step before a new medicine might be approved for wider use. It's crucial for understanding if the treatment is both effective and safe for people with COPD. The information we gather will help doctors and patients make informed decisions about future treatment options.
Key takeaways
- This study is testing a new medicine for moderate to severe COPD.
- It aims to reduce COPD flare-ups and improve lung function.
- Participants will receive either the new drug or a dummy treatment.
- It's a 'Phase 3' study, meaning it's a key step before potential broad use.
- Both former and current smokers are being studied, though the main focus is on former smokers.
- Your health and well-being will be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part.
The study is specifically looking for people who have been diagnosed with moderate to severe COPD and who used to smoke. We also need to confirm that your COPD meets certain criteria for the study.
As part of the screening process, the study team will ask you questions about your medical history and current health. They will also do some tests to make sure that taking part in the study would be safe for you and that you meet all the specific requirements. This helps us ensure the study is right for you and that the results will be meaningful.
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?
- Do you have moderate to severe COPD?
- Did you used to smoke cigarettes?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive either the study drug or a placebo?
What does participation involve?
If you decide to participate in this study, you will be in the study for a period of time, which the study team will explain in detail. You will have regular visits to the clinic, where you will meet with the study doctors and nurses. During these visits, you will have various health checks, including lung function tests (like blowing into a machine), blood tests, and heart activity tests (ECGs). You will also be asked about your symptoms and how you are feeling.
You will be given either the study medicine, itepekimab, or the placebo. This will be given in a specific way, and the study team will teach you how to take it correctly. You won't know if you're getting the active drug or the placebo, and neither will your study doctor – this is common in research to keep the results unbiased. Throughout the study, the team will closely monitor your health and any changes you experience. Your participation will involve following the study schedule, taking your assigned medication, and reporting any side effects or concerns to the study team.
Potential risks and benefits
Locations (12)
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedNorway
- —UnverifiedNetherlands
- —UnverifiedEstonia
- —UnverifiedLithuania
- —UnverifiedPortugal
- —UnverifiedBulgaria
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe, often caused by long-term exposure to irritants like cigarette smoke.
What is 'itepekimab'?
Itepekimab is the name of the new medicine being tested in this study. It's designed to target a specific part of the immune system that might play a role in COPD flare-ups.
What does 'placebo-controlled' mean?
This means some people will get the active study drug, and some will get a 'dummy' treatment (placebo) that looks the same but contains no medicine. This helps doctors see if the new drug really works better than no treatment.
What is a 'flare-up' or 'exacerbation' of COPD?
A COPD flare-up is when your breathing difficulties get suddenly worse, which might include more coughing, wheezing, or breathlessness than usual. It often requires extra treatment or a visit to the doctor.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is to ensure the study results are fair and unbiased.
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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