RecruitingPHASE3INTERVENTIONAL

A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

This research is investigating a treatment called belimumab for adults who have a lung condition known as interstitial lung disease (ILD). ILD causes the lungs to become inflamed and stiff, leading to difficulties like shortness of breath and a persistent cough. It is often seen in people with certain autoimmune conditions, such as rheumatoid arthritis or lupus. The main goal of the study is to find out if adding belimumab to existing treatments can help keep lung function stable or even improve it. Researchers also want to see if it can relieve symptoms and if it's safe to use. Improving lung health and quality of life for people with ILD is very important, as this condition can be quite serious.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

440

Start

11 Sep 2024

Estimated completion

13 Dec 2028

Lung Diseases, Interstitial

What is this study about?

This study is about a lung disease called interstitial lung disease (ILD). You might know it as a condition where your lungs become inflamed and stiff, making it harder to breathe. This often leads to symptoms like feeling short of breath, having a cough, and feeling very tired. ILD can be especially challenging and is a serious concern for people who also have certain autoimmune conditions, like lupus, rheumatoid arthritis, or Sjögren's syndrome. These are conditions where your body's immune system mistakenly attacks healthy tissues.

The researchers are testing a medication called belimumab. This drug is already used for some autoimmune diseases, and this study aims to see if it can also help people with ILD that is linked to these conditions. The main idea is to find out if belimumab, when given alongside the usual treatments, can help stop the ILD from getting worse or even make the lungs work better. They also want to see if it helps with your symptoms and if it's a safe treatment option.

Ultimately, the goal is to improve the health and quality of life for people living with ILD. If this study shows that belimumab is both safe and effective, it could offer a new way to help manage this difficult lung condition.

Key takeaways

This study is for adults with a lung condition called ILD linked to autoimmune diseases.
It tests a drug called belimumab to see if it can help improve or stabilise lung function.
Participants will receive either belimumab or a placebo alongside their regular treatment.
Safety and symptom relief are important parts of what the study is looking for.
Regular health checks and lung tests will be part of taking part.
The study aims to find new ways to help people living with ILD.

Who may be eligible?

To join this study, adults must have interstitial lung disease (ILD) that is linked to certain connective tissue diseases like rheumatoid arthritis, lupus, or other similar conditions. Your lung disease should have been getting worse or not getting better with your current treatments. Also, your ILD should show up on a special type of X-ray scan called a HRCT, affecting at least 10% of your lungs.

You should either be currently on stable treatment for your lung or autoimmune condition, or your previous treatments didn't work well or you couldn't tolerate them. You also need to be able to give yourself the study medication or have someone who can help you with it. Women need to confirm they are not pregnant or breastfeeding, and if they could become pregnant, they must be using effective contraception.

There are also some reasons why you might not be able to join. For example, if your ILD isn't linked to a connective tissue disease, or if you have a primary diagnosis of systemic sclerosis. People whose lung disease is getting worse very quickly, or if their lung function is already very low (below 45% of what's expected), would also not be able to 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.

Do you have a diagnosis of interstitial lung disease (ILD)?
Is your ILD linked to an autoimmune condition like rheumatoid arthritis or lupus?
Has your lung disease not improved or been getting worse with current treatments?
Are you 18 years old or older?
If you are a woman, are you not pregnant or breastfeeding, or are you using effective contraception?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive either the study medication, belimumab, or a placebo (a dummy treatment without any active drug). This will be given in addition to your current regular treatment for your lung and autoimmune condition. The study involves regular visits to the clinic where you'll have various tests to check your lung function, assess your symptoms, and monitor your overall health and safety. These tests might include breathing tests, blood tests, and physical examinations. You'll also be asked about your symptoms and how you're feeling. The total duration of your participation in the study, including follow-up appointments, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving a new treatment that might help stabilise or improve your lung condition and symptoms, which are being closely monitored by medical professionals. However, there are potential risks, as with any medication, including potential side effects from belimumab or the placebo. The study team will carefully monitor your health and any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (131)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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San Francisco, United States· Recruiting
GSK Investigational Site
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Upland, United States· Recruiting
GSK Investigational Site
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Gainesville, United States· Recruiting
GSK Investigational Site
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Naples, United States· Recruiting
GSK Investigational Site
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St Louis, United States· Recruiting
GSK Investigational Site
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New York, United States· Recruiting
GSK Investigational Site
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New York, United States· Recruiting
GSK Investigational Site
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Potsdam, United States· Recruiting
GSK Investigational Site
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Durham, United States· Recruiting

Common questions

What is interstitial lung disease (ILD)?

ILD is a condition where your lungs become inflamed and stiff, making it hard to breathe and causing symptoms like cough and tiredness.

What is belimumab?

Belimumab is a medicine that helps control your immune system. Researchers are testing if it can help with ILD.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study drug but doesn't contain any active medicine. It helps compare the real treatment's effects.

How long will the study last?

The exact duration of the study for each participant will be explained by the study team, including your regular visits and follow-up.

Will I still receive my current treatments?

Yes, belimumab or the placebo will be given in addition to your usual, stable treatments for your lung and autoimmune condition.

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.