Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
This research study is investigating a new medicine called Depemokimab for people with asthma. Asthma can make your airways narrow and swollen, leading to symptoms like coughing, wheezing, and breathlessness that can change and get worse unexpectedly. This study aims to understand how Depemokimab, which is a type of antibody therapy, changes the way the lungs work and look in people with a specific kind of asthma where certain cells (eosinophils) are high. The goal is to see if this new treatment can help improve breathing and reduce asthma flare-ups for those who have this particular type of asthma.
At a glance
What is this study about?
Asthma is a common long-term condition that affects your airways, the tubes that carry air in and out of your lungs. When you have asthma, these airways can become very sensitive, inflamed, and swollen, making it difficult to breathe. This can lead to coughing, wheezing, shortness of breath, and a tight feeling in your chest. The symptoms can vary from person to person and can sometimes get worse suddenly, which is called an asthma attack or exacerbation. While there are many treatments available, finding better ways to manage asthma is always important.
This particular study is looking at a new medicine called Depemokimab. Depemokimab is a type of treatment known as a 'monoclonal antibody'. These are specially designed proteins that target specific parts of the body's immune system. In this case, Depemokimab is being studied for a specific type of asthma where there's a lot of inflammation caused by certain immune cells called 'eosinophils'. This type of asthma is often referred to as 'type 2 inflammation' or 'eosinophilic asthma'.
The main aim of this study is to understand how Depemokimab affects the lungs in people with this specific type of asthma. Researchers want to see if it changes the structure of the lungs, how well they work, and, ultimately, if it can help improve symptoms and reduce the number of severe asthma flare-ups. By studying this, doctors hope to develop more effective treatments for people living with asthma.
Key takeaways
- This study is testing a new asthma medicine called Depemokimab.
- It's for adults with a specific type of asthma linked to high eosinophil levels.
- You need to have had asthma for at least two years and still have symptoms despite current treatment.
- The study aims to understand how the new medicine affects your lungs.
- Participation involves medical checks and potentially new treatments.
Who may be eligible?
To join this study, you would need to be an adult, aged 18 or older. You must have had a diagnosis of asthma for at least two years and your asthma needs to be well-documented by a doctor, following recognised guidelines in the UK, such as those from NICE or GINA. A key requirement is that you have a specific type of asthma where your blood tests show high levels of certain cells called eosinophils (meaning your count is 300 or more). Also, another breathing test (FeNO) needs to show a reading of 25 or higher, which indicates a particular kind of inflammation in your airways.
Your asthma should also be considered 'uncontrolled', even though you're already taking medium to high doses of inhaled steroids (ICS) and at least one other asthma controller medicine. This is usually checked using a questionnaire called ACQ-5, where your score would need to be above 1.5. Additionally, your doctor needs to confirm that you’ve had at least two severe asthma flare-ups in the last year that needed treatment with steroid tablets, injections, or drips. Your lung function, measured by a test called FEV1, would also need to be less than 80% of what is expected for someone your age and height.
While men have no specific extra requirements, women who might become pregnant would need to be using effective contraception throughout the study. Women who are pregnant or breastfeeding cannot take part. The research team will carefully check all these requirements to make sure the study is right for you and that you meet all the necessary criteria.
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 asthma for at least 2 years?
- Do your blood tests or breathing tests show signs of a specific type of asthma inflammation (high eosinophils or FeNO)?
- Have you had at least two severe asthma flare-ups needing steroid tablets/injections in the last year?
- Are you currently taking medium to high doses of inhaled steroids and at least one other asthma medicine?
- Are your asthma symptoms still not fully controlled?
What does participation involve?
The detailed information about what taking part involves is not provided in your summary. We would expect information on the number of clinic visits, how often they occur, the types of tests and procedures that would be carried out (e.g., blood tests, lung function tests, bronchoscopies, imaging scans), how the study medication is given (e.g., injection, tablets), how long you would be taking the treatment, and any follow-up appointments after the treatment ends. The total duration of your participation, from your first screening appointment to your final follow-up, would also be provided.
Potential risks and benefits
Locations (43)
- GSK Investigational SiteVerified postcodeBrooksville, United States· Recruiting
- GSK Investigational SiteVerified postcodePlantation, United States· Recruiting
- GSK Investigational SiteVerified postcodeKansas City, United States· Recruiting
- GSK Investigational SiteVerified postcodeSt Louis, United States· Recruiting
- GSK Investigational SiteVerified postcodeNew Brunswick, United States· Recruiting
- GSK Investigational SiteVerified postcodeNew York, United States· Recruiting
- GSK Investigational SiteVerified postcodeDuBois, United States· Recruiting
- GSK Investigational SiteVerified postcodePhiladelphia, United States· Recruiting
- GSK Investigational SiteVerified postcodeMcKinney, United States· Recruiting
- GSK Investigational SiteVerified postcodeMechelen, Belgium· Recruiting
- GSK Investigational SiteVerified postcodeNamur, Belgium· Recruiting
- GSK Investigational SiteVerified postcodeAjax, Canada· Recruiting
Common questions
What is Depemokimab?
Depemokimab is a new type of medicine called a 'monoclonal antibody' that is being investigated for treating a specific kind of asthma.
What kind of asthma is this study for?
It's for people with a specific type of asthma where certain cells called 'eosinophils' are high, indicating a particular kind of inflammation in the airways.
Why are they doing this study?
The study aims to understand how Depemokimab affects the lungs of people with this type of asthma, hoping to find better ways to manage the condition.
Will I get the actual medicine if I join?
In many trials, participants may receive the study medicine or a placebo (a dummy medicine). The researchers will explain how this works in this specific trial.
What does 'uncontrolled asthma' mean in this study?
It means your asthma symptoms are still causing problems, even though you are already taking your regular asthma medications.
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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