A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This research study is investigating an experimental medication called belimumab for adults living with a specific lung condition known as Interstitial Lung Disease (ILD) that is connected to Systemic Sclerosis (also called scleroderma). The main goal is to find out if belimumab, when added to usual care, is both safe and effective. Researchers will compare it to a dummy treatment (placebo). They will closely monitor how belibilities on lung function, but also look at other common issues tied to scleroderma, like skin thickness and overall well-being, including tiredness. Ultimately, they want to see if this new treatment can improve quality of life for those affected.
At a glance
What is this study about?
This research study is for adults who have a condition called Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD). Systemic Sclerosis, often just called scleroderma, is a long-term condition that affects the body's connective tissue, sometimes causing changes to the skin and internal organs, including the lungs. Interstitial Lung Disease means the tissue around the air sacs in the lungs becomes scarred or inflamed, making it harder to breathe.
The study is looking at a new medication called belimumab. Participants will either receive belimumab or a 'placebo', which looks identical but contains no active medicine. This comparison helps researchers understand if belimumab truly has an effect beyond what might happen naturally or from receiving a dummy treatment. It's important to remember that all participants will continue to receive their standard medical care alongside the study treatment.
The main aim is to see if belimumab can help improve lung function. However, the researchers are also interested in whether it can reduce other problems linked to scleroderma, such as the thickening of the skin and general symptoms like fatigue (extreme tiredness) that can significantly impact a person's daily life and overall well-being. By studying these effects, the hope is to find better ways to manage SSc-ILD and improve quality of life for those affected.
Key takeaways
- This study evaluates a new treatment for lung disease linked to scleroderma.
- It aims to improve lung function and other symptoms like skin thickening and tiredness.
- Participants will receive either the study drug or a dummy treatment, alongside their usual care.
- The study looks at both the safety and effectiveness of the new medication.
- Participation involves regular clinic visits for tests and assessments.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You must have a confirmed diagnosis of Systemic Sclerosis (SSc) with specific signs of thickened skin on your body. Importantly, you also need to have evidence of Interstitial Lung Disease (ILD) in your lungs, as shown by a special type of X-ray called a HRCT scan, and your disease should be active or getting worse.
There are also some specific medical requirements, such as certain antibody test results and having an area of skin where injections can be given easily. If you are a woman, you must not be pregnant or breastfeeding, and you must either be past childbearing age or using a very reliable method of contraception.
Some things would prevent you from joining. For example, if your scleroderma-like illness is caused by other specific conditions, environmental factors, or certain medications. You also wouldn't be eligible if you have another main autoimmune disease like rheumatoid arthritis.
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 18 years old or older?
- Do you have a diagnosis of Systemic Sclerosis (scleroderma)?
- Do you have Interstitial Lung Disease (ILD) associated with your scleroderma?
- Is your disease considered active or progressive?
- If you are a woman, are you not pregnant or breastfeeding and using effective contraception if needed?
What does participation involve?
If you join this study, it will involve regular visits to the clinic over a period of time. During these visits, the study team will carry out various assessments to monitor your health, including scans, blood tests, and checks of your lung function. You will receive either the study medication (belimumab) or a placebo, which is given as an injection under the skin. You or a trained caregiver will be shown how to give these injections at home.
The study will also track how your skin thickness changes and ask you about your general symptoms, like tiredness, to understand how the treatment affects your overall well-being and quality of life. The total duration of your participation in the study, including all treatments and follow-up appointments, will be explained in detail by the study team.
Potential risks and benefits
Locations (131)
- GSK Investigational SiteVerified postcodePhoenix, United States· Completed
- GSK Investigational SiteVerified postcodeScottsdale, United States· Recruiting
- GSK Investigational SiteVerified postcodeScottsdale, United States· Recruiting
- GSK Investigational SiteVerified postcodeTucson, United States· Recruiting
- GSK Investigational SiteVerified postcodeLos Angeles, United States· Recruiting
- GSK Investigational SiteVerified postcodeLos Angeles, United States· Recruiting
- GSK Investigational SiteVerified postcodeLos Angeles, United States· Recruiting
- GSK Investigational SiteVerified postcodeUpland, United States· Recruiting
- GSK Investigational SiteVerified postcodeAurora, United States· Recruiting
- GSK Investigational SiteVerified postcodeWashington D.C., United States· Recruiting
- GSK Investigational SiteVerified postcodeJacksonville, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
Common questions
What is systemic sclerosis and interstitial lung disease?
Systemic Sclerosis (scleroderma) is a condition affecting connective tissue. Interstitial Lung Disease is a lung problem where the tissue around the air sacs becomes inflamed or scarred, often linked with scleroderma.
What is belimumab?
Belimumab is a study medication being tested to see if it can help people with lung problems related to scleroderma.
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual drug.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of study, neither you nor your doctor will know if you are receiving belimumab or the placebo. This helps ensure fair and unbiased results.
What does 'Phase 2/3' mean?
Phase 2/3 means this study is in a combined stage. Phase 2 tests the drug's effectiveness and safety in a larger group, and Phase 3 looks at its effectiveness compared to standard treatments and monitors side effects in an even larger group.
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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