A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
This research study is looking into a new medicine called Depemokimab. It's for adults and teenagers (aged 12 and above) who have a specific kind of asthma, sometimes called 'Type 2 asthma', which often leads to severe flare-ups. The main goal is to find out if Depemokimab, when added to your usual asthma treatment, is better at preventing or reducing these flare-ups compared to a dummy medicine (placebo) or just your regular care. Researchers want to check both how well it works and if it's safe to use. By comparing it to existing treatments, the study hopes to discover new ways to help people manage their asthma more effectively.
At a glance
What is this study about?
This study is about a new medicine called Depemokimab, and it's looking for people with a type of asthma that often causes serious breathing problems or 'flare-ups'. If you have asthma that sometimes gets much worse, even when you're using your regular inhalers, this study might be for you. The researchers want to see if Depemokimab can help stop these flare-ups from happening as often or make them less severe. They are also carefully checking to make sure the medicine is safe.
At the moment, people with this type of asthma use their usual inhalers and sometimes need extra medicines like steroid tablets when they have a flare-up. This study will compare Depemokimab with a 'placebo' (a dummy medicine that looks the same but contains no active drug) and your current standard asthma care. This comparison helps the researchers understand if Depemokimab is truly making a difference. It's a 'Phase 3' study, which means it's one of the final steps before a medicine might become widely available, so it involves a larger number of people to gather more detailed information.
The aim is to find better ways to manage severe asthma and improve the lives of people who live with it. By taking part, you could contribute to medical knowledge and potentially help others with similar asthma in the future. Remember, taking part in a study is always a personal choice.
Key takeaways
- This study is testing a new medicine, Depemokimab, for severe asthma.
- It's for adults and teenagers (12+) with a history of asthma flare-ups.
- Participants will receive either Depemokimab or a dummy medicine (placebo).
- You will continue using your regular asthma inhalers during the study.
- The goal is to see if Depemokimab can reduce asthma flare-ups and is safe.
- Taking part is voluntary and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be at least 12 years old. In some countries, you might need to be 18 or older to take part. You must have been officially diagnosed with asthma by a doctor for at least two years, and your asthma should meet certain recognised health guidelines.
Your asthma also needs to be the kind that has caused you to have at least two serious flare-ups in the last three years, with one of those happening in the past year. A 'flare-up' means you needed to take steroid tablets for at least three days, even though you were using your regular asthma inhalers (a mix of a steroid and a bronchodilator) at a low to medium strength. You also need to have been using these low to medium strength inhalers consistently for the last 12 months, and your treatment should have been stable for three months before the study starts. Please note, there's a limit on how many people using low-dose inhalers can join.
If you are a woman who could become pregnant, you'll need to use very effective contraception (birth control) during the study, or already be past childbearing age. Men taking part don't have special contraception requirements for their partners. These rules are in place to keep everyone safe during the study.
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 12 years old or older?
- Have you been diagnosed with asthma for at least 2 years?
- Have you had at least 2 serious asthma flare-ups in the last 3 years, with one in the past year, needing steroid tablets?
- Are you currently using a low to medium dose of your regular steroid/bronchodilator inhaler?
- If you are a woman who could become pregnant, are you willing to use effective birth control during the study?
What does participation involve?
If you join the study, you'll be given either the new medicine, Depemokimab, or a placebo (a dummy medicine). You won't know which one you're receiving, and neither will your study doctor, until after the study is over. You will continue to take your usual asthma medicines alongside the study treatment. You'll have regular visits to the study clinic where the team will monitor your asthma, check your breathing, take blood samples, and ask about your health and any side effects you might be experiencing. They'll also provide you with the study medicine. The total length of time you'll be involved in the study will be explained in full by the study team, and it typically involves regular follow-up over several months.
Potential risks and benefits
Locations (17)
- GSK Investigational SiteVerified postcodeLittle Rock, United States· Recruiting
- GSK Investigational SiteVerified postcodeNewport Beach, United States· Recruiting
- GSK Investigational SiteVerified postcodeAurora, United States· Recruiting
- GSK Investigational SiteVerified postcodeAventura, United States· Recruiting
- GSK Investigational SiteVerified postcodeKissimmee, United States· Recruiting
- GSK Investigational SiteVerified postcodeLake Worth, 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 postcodeShreveport, United States· Recruiting
- GSK Investigational SiteVerified postcodeOklahoma City, United States· Recruiting
- GSK Investigational SiteVerified postcodeDuBois, United States· Recruiting
Common questions
What is 'Type 2 Asthma'?
Type 2 Asthma is a specific kind of asthma where certain immune cells and proteins are more active, leading to inflammation in your airways. It often causes severe symptoms and frequent flare-ups.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study medicine but contains no active drug. It helps researchers see if the actual medicine is truly having an effect, beyond what might happen naturally or from simply receiving care.
Will I still take my regular asthma medicine?
Yes, you will continue to take your usual asthma medicines (like your steroid/bronchodilator inhaler) alongside the study medicine. The study medicine is an 'add-on' treatment.
What is a 'flare-up' in this study?
In this study, a flare-up means an asthma worsening that was severe enough for you to need steroid tablets for at least three days, even while using your regular inhalers.
Is this medicine available to everyone?
No, Depemokimab is an investigational medicine, meaning it's still being tested and is not yet approved for general use. It's only available to people taking part in this specific research study.
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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