RecruitingPHASE3INTERVENTIONAL

A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)

This research is an ongoing study looking at a medicine called belimumab. It's for adults who have lung disease (called Interstitial Lung Disease or ILD) caused by conditions like Systemic Sclerosis or other similar autoimmune diseases. Essentially, it's an extension of two earlier studies and wants to find out how safe belimumab is over a longer time and if it continues to help with lung function. The study also aims to see if the medicine can slow down the overall progress of the disease and improve the quality of life for those taking part. It's for people who have already completed one of the initial studies.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

514

Start

12 Dec 2024

Estimated completion

27 Dec 2029

Connective Tissue Diseases

What is this study about?

This study is a continuation of previous research looking at a medicine called belimumab. It's specifically for adults who have a lung condition known as Interstitial Lung Disease (ILD). This lung problem often happens in people with autoimmune diseases, where the body's immune system mistakenly attacks its own tissues. Examples include Systemic Sclerosis (sometimes called scleroderma) or other similar conditions affecting the body's connective tissues.

The main goal of this study is to see how safe belimumab is when taken for a longer period. Researchers also want to find out if it continues to help slow down the decline in lung function, which is a common issue for people with these conditions. They will also be checking if the medicine helps to slow the overall progression of the disease and if it makes a positive difference to everyday life and well-being.

This is an 'open-label extension' study, meaning everyone participating will receive belimumab if they are eligible. It's important to know that you can only join this study if you have already taken part in and successfully completed one of the two earlier studies (known as studies 218224 or 221672). You would have completed these studies up to the 52-week visit and not had to stop your study medication early for any reason.

Key takeaways

This study is for adults with lung disease (ILD) linked to conditions like Systemic Sclerosis.
It's exploring the long-term safety and effectiveness of a medicine called belimumab.
You must have completed a previous related study to be eligible for this one.
The study aims to see if belimumab continues to help lung function and overall disease progression.
You will give yourself the medicine by injection, or have help from someone else.
Your well-being and any side effects will be closely monitored by the study team.

Who may be eligible?

To be part of this study, you must have already completed one of the two previous related studies (study 218224 or 221672) right up to the 52-week mark. You also must not have stopped your medicine early during those previous studies.

You need to have Interstitial Lung Disease (ILD) either linked to Systemic Sclerosis or another similar connective tissue disease. If you have Systemic Sclerosis, there must be a suitable area on your tummy or thigh where injections can be given, as decided by the study doctor.

You should be able and willing to inject the study medicine yourself, or have a family member, friend, or nurse who can help you with this. For women, you cannot be pregnant or breastfeeding. If you could become pregnant, you must be using very effective contraception (birth control) and continue to do so for at least four months after your last dose of study medicine.

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.

I have already finished studies 218224 or 221672 up to 52 weeks.
I did not stop my study medicine early in those previous studies.
I have Interstitial Lung Disease (ILD) linked to Systemic Sclerosis or another similar connective tissue disease.
I am able to give myself injections, or have someone who can help me.
If I am a woman who could become pregnant, I am using very effective contraception.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be taking belimumab, the study medication. You'll likely have regular appointments at the clinic for assessments and to check how you're feeling and how the medicine is working. These appointments will involve blood tests, physical exams, and tests to check your lung function. You will either give yourself the injections or have someone help you. The study aims to look at the long-term effects of belimumab, so it will continue for an extended period, which will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of continuing to receive belimumab, which could help manage your lung condition and overall disease progression. However, like all medicines, belimumab can have side effects, which the study team will discuss with you. You will be closely monitored for any potential risks or side effects throughout the study. Remember, joining a clinical study is always a personal choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

GSK Investigational Site
Verified postcode
Philadelphia, United States· Recruiting
GSK Investigational Site
Unverified
Ciudad Autonoma Buenos Aires, Argentina· Recruiting
GSK Investigational Site
Unverified
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
GSK Investigational Site
Verified postcode
Beijing, China· Recruiting
GSK Investigational Site
Verified postcode
Zhuzhou, China· Recruiting
GSK Investigational Site
Verified postcode
Larissa, Greece· Recruiting
GSK Investigational Site
Unverified
Hokkaido, Japan· Recruiting
GSK Investigational Site
Verified postcode
Tokyo, Japan· Recruiting
GSK Investigational Site
Unverified
Yongsan-Ku Seoul, South Korea· Recruiting
GSK Investigational Site
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Interstitial Lung Disease (ILD)?

ILD is a group of conditions that cause scarring in the lungs, making it harder to breathe. It can be linked to autoimmune diseases.

What is belimumab?

Belimumab is a medicine that works by affecting your immune system. It's being studied to see if it can help with lung problems in people with certain autoimmune conditions.

Do I have to take part if I'm eligible?

No, taking part in any study is completely voluntary. You can decide if it's right for you after discussing it with your doctor.

Will I know if I'm getting the actual medicine or a dummy treatment?

In this specific study, everyone who is eligible and joins will receive belimumab. It's an 'open-label' study, meaning there's no dummy medicine.

How long will this study last?

This study is designed to look at the long-term effects of belimumab, so it will continue for an extended period. The study team will provide more specific details.

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.