RecruitingPHASE3INTERVENTIONAL

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

This important study is looking into a new medicine called depemokimab for people in the UK who have moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). Specifically, it's for those whose COPD is linked to a certain type of inflammation in their body, called 'Type 2 inflammation'. The main goals are to find out if taking depemokimab early as an extra treatment can help people breathe better, make them feel generally well, and reduce the number of serious flare-ups (exacerbations). Researchers also want to make sure the medicine is safe. Participants will either receive depemokimab or a dummy medicine (placebo) to compare the effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

1,196

Start

20 Oct 2025

Estimated completion

08 Jun 2029

Pulmonary Disease, Chronic Obstructive

What is this study about?

Imagine your lungs are like a tree, with branches called airways that carry air in and out. In people with COPD, these airways become inflamed and narrowed, making it harder to breathe. This study is for people with moderate to severe COPD, which means their breathing problems are noticeable and can sometimes lead to serious flare-ups.

Researchers are investigating a new medicine called depemokimab. This medicine targets a specific type of inflammation in the body, known as 'Type 2 inflammation,' which can make COPD worse for some individuals. The study aims to see if starting depemokimab early, in addition to their usual inhaler treatment, can make a difference.

The main purpose is to evaluate if depemokimab helps improve breathing, reduces flare-ups, and is safe to use. By taking part, you could help doctors understand how to better treat COPD in the future, especially for those with Type 2 inflammation. This kind of research is crucial for finding new and more effective ways to manage long-term conditions like COPD.

Key takeaways

This study is for people with moderate to severe COPD and specific 'Type 2 inflammation'.
It tests a new medicine called depemokimab against a dummy medicine (placebo).
Aims to see if early treatment with depemokimab improves breathing and reduces flare-ups.
Participation involves clinic visits, tests, and taking study medication.
You'll continue your usual COPD inhalers alongside the study treatment.
Your health will be closely monitored by the study team throughout.

Who may be eligible?

This study is looking for men and women aged 40 to 75 who have had COPD for at least one year. Your COPD should be moderate to severe, and your doctor will need to confirm that your type of COPD likely includes 'Type 2 inflammation', usually checked with a blood test. You should also have had at least one COPD flare-up in the last year or have certain risk factors for future flare-ups, such as significant breathlessness or a particular score on a COPD survey.

You should currently be using either two or three different types of inhalers together (like an ICS+LABA or ICS+LABA+LAMA) for at least three months. You also need to have a history of smoking for at least 10 'pack-years', which is a way of measuring how much you've smoked over time. Your body mass index (BMI) should also be 16 or above.

People with other significant lung diseases, a current, or recent doctor's diagnosis of asthma (unless it was childhood asthma that completely went away before age 18 and hasn't returned), or those who have had many severe COPD flare-ups recently, wouldn't be able to join this particular study. The doctors need to be sure that your COPD is your main lung problem.

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 75 years old?
Do you have moderate to severe COPD diagnosed by a doctor for at least a year?
Has your doctor mentioned your COPD might involve 'Type 2 inflammation'?
Have you had at least one COPD flare-up in the last year, or do you have risk factors for more?
Are you currently using two or three types of inhalers together for your COPD?
Do you have a smoking history of at least 10 'pack-years'?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be regularly seen by the study doctors and nurses. This will involve several visits to the clinic over a period of time. At these visits, you'll have various assessments, which may include breathing tests, blood tests, and questionnaires to check your symptoms and how you're feeling. You'll be given either the new medicine, depemokimab, or a dummy medicine (placebo) to take regularly, in addition to your current COPD medication. The study will also involve follow-up appointments after you've finished taking the study medicine. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new investigational medication and having your health closely monitored by specialists. However, it's also important to be aware of potential risks. Depemokimab is a new medicine, so there might be side effects that are not yet fully known. You might also receive the placebo and not the active drug. The study team will explain all known risks and carefully monitor you throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (121)

GSK Investigational Site
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Newport Beach, United States· Recruiting
GSK Investigational Site
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Lakewood, United States· Recruiting
GSK Investigational Site
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Brandon, United States· Recruiting
GSK Investigational Site
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Crystal River, United States· Recruiting
GSK Investigational Site
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Doral, United States· Recruiting
GSK Investigational Site
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Greenacres City, United States· Recruiting
GSK Investigational Site
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Hialeah, United States· Recruiting
GSK Investigational Site
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Hollywood, United States· Recruiting
GSK Investigational Site
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Miami, United States· Recruiting
GSK Investigational Site
Verified postcode
Miami, United States· Recruiting
GSK Investigational Site
Verified postcode
Miami, United States· Recruiting
GSK Investigational Site
Verified postcode
Miami Lakes, United States· Recruiting

Common questions

What is 'Type 2 inflammation' mentioned in the study?

Type 2 inflammation is a specific kind of immune response in the body that can make conditions like COPD worse for some people. This study focuses on individuals whose COPD is linked to this type of inflammation.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the new medicine to see if the new medicine genuinely works better.

Will I know if I'm getting depemokimab or the placebo?

No, you won't know this during the study. This is called 'blinding' and it helps ensure the study results are fair and unbiased. Your doctor won't know either.

What does 'pack-years' mean?

Pack-years is a way of measuring how much someone has smoked. For example, smoking one pack of cigarettes a day for 10 years would be 10 pack-years.

Can I continue my usual COPD inhalers during the study?

Yes, this study is testing depemokimab as an 'add-on' medicine. You will continue taking your usual inhaler therapy as prescribed by your doctor.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.