RecruitingPHASE2INTERVENTIONAL

A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis

This study is investigating a new medication called GSK3862995B for adults who have a long-term lung condition called bronchiectasis. The main goal is to find out if this new drug is safe to use and if it can help improve the condition, compared to a placebo (a dummy drug with no active ingredients). Participants will be randomly assigned to receive either the new drug at different doses or the placebo. Researchers will also look at how the body uses and processes the drug, and if there are any immune reactions. This research is important because it could lead to new ways to help people living with bronchiectasis feel better and manage their symptoms.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

446

Start

30 Oct 2025

Estimated completion

10 Dec 2027

Bronchiectasis

What is this study about?

This study is focused on a new potential treatment, called GSK3862995B, for people living with bronchiectasis. Bronchiectasis is a long-term condition where the airways of your lungs become widened and scarred, leading to symptoms like a persistent cough, mucus production, and frequent chest infections. There isn't a cure for bronchiectasis, so finding new ways to manage it and improve people's lives is very important.

The main purpose of this study is to carefully check if the new drug, GSK3862995B, is both safe and effective in adults with bronchiectasis. Researchers will compare how well the drug works against a 'placebo' – which looks just like the study drug but contains no active ingredients. This comparison helps scientists understand the true effects of the new medication. They'll also be observing how your body handles the drug and if it causes any unexpected immune responses.

By taking part, you could contribute to medical knowledge that might help many other people with bronchiectasis in the future. The results of this study will help doctors decide if GSK3862995B could become a new, helpful treatment option.

Key takeaways

This study is testing a new drug for adults with bronchiectasis.
It aims to check if the drug is safe and effective compared to a dummy drug.
Participation involves regular clinic visits, taking study medication, and various tests.
You might receive the new drug or a placebo.
You can withdraw from the study at any time.
Your involvement could help future patients with bronchiectasis.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old with bronchiectasis. Your diagnosis must be confirmed by a chest CT scan, and you should have had some recent issues with your lungs, such as needing antibiotics for two or more chest infections in the last year, or being hospitalised for one, or having a low quality of life score due to your condition. You also need to be producing sputum (phlegm) and have a certain level of lung function after using an inhaler.

There are also some requirements about your general health and habits. For example, your body mass index (BMI) should be between 18 and 35. You must also be a non-smoker or have quit smoking. If you're a woman, you can't be pregnant or breastfeeding, and if you can become pregnant, you'll need to use very effective contraception.

However, some conditions would mean you can't take part. This includes if your main lung problem is asthma or COPD, or if your bronchiectasis is caused by certain other specific conditions like cystic fibrosis. You also can't have an active lung infection like certain types of mycobacterial infection or tuberculosis. The study team will go through all these details with you carefully to see if you're a good fit.

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 an adult aged 18 to 85?
Do you have a diagnosis of bronchiectasis confirmed by a CT scan?
Have you had recent chest infections or a low quality of life due to bronchiectasis?
Do you produce sputum (phlegm)?
Are you a non-smoker or have you quit smoking?
If you are a woman, are you not pregnant, not breastfeeding, and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of three groups: two groups will receive different doses of the new drug, and one group will receive a placebo (a dummy drug). This means you won't know whether you are getting the active drug or the placebo, and neither will your study doctor. You'll take the study medication regularly for a set period. Throughout the study, you'll have regular hospital or clinic visits where the study team will carry out various assessments. These might include breathing tests, blood tests to check how your body is reacting to the drug and to see for any immune responses, and questionnaires about your symptoms and how you're feeling. They'll also check for any side effects. The total duration of your participation in the study, including all visits and follow-ups after you stop taking the drug, will be explained in detail before you agree to take part.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You might receive a new drug that could help improve your bronchiectasis symptoms, or you could receive very close medical monitoring and care throughout the study. However, like all new medications, there's a chance the study drug might not help you, or it could cause side effects. Some procedures, like blood tests, also carry small risks such as bruising or discomfort. You will be closely monitored for any unwanted effects and have the opportunity to discuss any concerns with the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (46)

GSK Investigational Site
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Mobile, United States· Recruiting
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La Palma, United States· Recruiting
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Miami, United States· Recruiting
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Miami, United States· Recruiting
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Naples, United States· Recruiting
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Plantation, United States· Recruiting
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Rockville, United States· Recruiting
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DuBois, United States· Recruiting
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Anderson, United States· Recruiting
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Rock Hill, United States· Recruiting
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Spartanburg, United States· Recruiting

Common questions

What is bronchiectasis?

Bronchiectasis is a long-term lung condition where your airways become widened and damaged, leading to infections and breathing problems.

What is GSK3862995B?

GSK3862995B is a new medicine being tested in this study to see if it can help adults with bronchiectasis.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study drug but contains no active ingredients. It helps researchers compare the real effects of the drug.

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

No, you won't know. The study is 'blinded', meaning neither you nor your study doctor will know which treatment you are receiving.

How long will I be in the study?

The total length of your participation, including all follow-up, will be clearly explained by the study team before you join.

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.