Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
This study, called ENDURA-2, is investigating a new medication called depemokimab. It's designed for adults aged 40 to 80 who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD) and show signs of 'Type 2 inflammation'. The main goal is to find out if depemokimab is effective and safe when used alongside their regular inhaler treatments. Researchers want to see if it can help reduce flare-ups and improve overall lung health for people whose COPD is not well-controlled with their current medicines. Participants will either receive depemokimab or a dummy medicine (placebo) to compare the results carefully.
At a glance
What is this study about?
This research study is looking into a new medicine called depemokimab for adults with Chronic Obstructive Pulmonary Disease, often known as COPD. COPD makes it hard to breathe because of damage to the lungs, and it can cause symptoms like coughing, wheezing, and shortness of breath. This particular study focuses on people who have moderate to severe COPD and also show a specific type of body response called 'Type 2 inflammation'.
The aim of the study is to see if depemokimab, when added to a person's existing inhaler treatment, can help manage their COPD better. The researchers want to know if it can reduce the number of times people have severe flare-ups (exacerbations) and improve their overall lung health and quality of life. They will also be carefully checking for any side effects to make sure the medicine is safe.
The study is designed to compare depemokimab with a 'placebo' – which looks exactly like the study medicine but contains no active drug. This helps the researchers understand the true benefits of depemokimab. By taking part, you could contribute valuable information that helps develop new treatments for people living with COPD.
Key takeaways
- This study is testing a new medicine, depemokimab, for moderate to severe COPD.
- It's for adults aged 40-80 with uncontrolled COPD and 'Type 2 inflammation'.
- The new medicine will be compared to a dummy medicine (placebo).
- Participation involves regular clinic visits and health checks.
- The study aims to see if depemokimab improves symptoms and is safe.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult between 40 and 80 years old. You must have been diagnosed with moderate to severe COPD for at least a year, and your current inhaler treatments shouldn't be fully controlling your symptoms. This means you should have experienced frequent flare-ups in the past year. Also, blood tests will show a specific type of inflammation in your body. You should be taking a combination of three types of inhaler medicines for at least six months before starting the study.
There are also some reasons why you might not be able to join. For example, if you've ever been diagnosed with asthma, or if your doctor thinks another lung condition is causing most of your breathing problems. You also can't have had pneumonia, a COPD flare-up, or a chest infection in the four weeks before starting the study. Certain lung surgeries or being in the middle of an intensive lung rehabilitation program would also mean you couldn't take part.
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 between 40 and 80 years old?
- Do you have moderate to severe COPD diagnosed for at least a year?
- Have you had frequent COPD flare-ups recently?
- Are you currently using three types of inhaler medicines for your COPD?
- Have you NOT had asthma diagnosed in the past?
- Have you NOT had a lung infection or flare-up in the last 4 weeks?
What does participation involve?
If you decide to take part, you'll be given either the study medicine (depemokimab) or a placebo, which looks identical but has no active drug. You won't know which one you're receiving, nor will your study doctor. This is called a 'blinded' study, which helps make sure the results are fair. You'll continue using your regular inhalers throughout the study.
You'll need to attend several visits to the study clinic. These visits will involve health checks, breathing tests, blood tests, and discussions about your symptoms and how you're feeling. The study team will provide you with the study medicine. The total duration of your participation will be explained by the study team, but it's typically for an extended period to properly assess the medicine's effects. Regular follow-up appointments will be scheduled to monitor your health and any effects of the medicine.
Potential risks and benefits
Locations (159)
- GSK Investigational SiteVerified postcodeSheffield, United States· Recruiting
- GSK Investigational SiteVerified postcodeAurora, United States· Recruiting
- GSK Investigational SiteVerified postcodeBrooksville, United States· Recruiting
- GSK Investigational SiteVerified postcodeDoral, United States· Recruiting
- GSK Investigational SiteVerified postcodeFort Lauderdale, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that causes breathing difficulties.
What is 'Type 2 inflammation'?
This is a specific type of immune response in the body, which can make COPD worse for some people.
Will I get the new medicine?
You will either receive the new medicine, depemokimab, or a dummy medicine called a placebo. The study team won't know which one you get.
How long does the study last?
The exact duration will be explained by the study team, but it's typically for an extended period to properly check the medicine's effects.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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