What next?
What next?
About this study
This Phase 3 clinical trial is looking at whether adding a drug called belimumab to standard therapy can help lung function for people with interstitial lung disease (ILD) that is linked to connective tissue diseases (CTDs) such as systemic sclerosis, rheumatoid arthritis, or lupus. Belimumab is an immunosuppressive medication already approved for certain autoimmune conditions. Researchers aim to understand more about the impact of taking the medication, and if it can help reduce inflammation or potentially slow lung scarring in CTD-ILD.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will be randomly assigned to receive either belimumab or a placebo, both in addition to your usual treatment. A placebo will look like the belimumab, but it will not contain any active ingredients; it is sometimes referred to as a dummy drug. The medication is administered once per week via syringe safety device which is prefilled and ready to use.
The study will look at any changes in your lung function over one year, focusing on the forced vital capacity (FVC), which is a key measure of lung health. Researchers will also assess symptom changes and monitor for any side effects. You will have lung function tests, other medical tests and you will also be asked to complete questionnaires at different points during the study.
There are different phases of the study.
1. Getting started: Screening
Before joining the study, you’ll go through a screening period. During this time, the research team will identify if the study is a good fit for you.
2. Study treatment: 52 weeks
For the next 52 weeks, you will receive either the study treatment or a placebo. You’ll be given the study drug once a week. Over the course of the year, you will have clinic visits so that the research team can check how you’re doing and perform various tests to understand the impact of the drug.
3. Wrapping up: follow-up
After the treatment period ends, there will be follow-up timeframe to check in on your health.
Summary of involvement
Taking part in the study for 1 year
Taking either the study drug or a placebo via a syringe safety device once per week
Medical assessments including lung function tests
Questionnaires
Can I take part?
You may be able to take part if you have a confirmed diagnosis of interstitial lung disease associated with a connective tissue disease.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see the main criteria list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
You have a confirmed diagnosis of one of the following autoimmune diseases: Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE), Inflammatory muscle diseases like polymyositis or dermatomyositis, Sjogren’s syndrome, Mixed connective tissue disease (MCTD)
You’ve been diagnosed with interstitial lung disease (ILD) that affects at least 10% of your lungs (seen on a special type of CT scan).
Your ILD has progressed in the past two years.
You’re currently on a stable treatment for your ILD, or you've tried standard treatment but it didn’t work or caused problems, and no longer take it.
You (or a caregiver) are able and willing to take (or give) the study drug via a syringe device throughout the study.
If you’re a woman:
You’re not pregnant or breastfeeding
You’re either not able to get pregnant or you’re using highly effective birth control
You have a type of ILD that’s not related to connective tissue disease (CTD).
Your main diagnosis is systemic sclerosis (a specific autoimmune disease).
Your disease is worsening quickly (for example, a major drop in lung function or recent hospital stay due to lung problems).
Your lung function (breathing test results) is very poor (FVC ≤ 45% or DLco ≤ 40%).
You have high blood pressure in your lungs (pulmonary hypertension) that needs treatment.
You rely on oxygen all the time.
You have serious health issues in other organs that could affect how your body handles medication or makes taking part dangerous.
You have COPD or similar lung problems that are worse than your ILD.
You’ve had cancer in the last 5 years (except certain skin cancers), or breast cancer in the last 10 years.
You've had major surgery recently or plan to during the study.
You have an active infection or history of frequent serious infections within the last 3 months.
What difference could taking part make?
Taking part in this study could help researchers better understand whether belimumab can slow the progression of CTD-ILD and improve quality of life for people living with the condition. Although there is no guarantee of personal benefit, participants may experience improvements in symptoms or lung function, and will receive close medical monitoring throughout the study. Your involvement could also contribute to future treatment options and help improve care for others living with CTD-ILD.
Where does the study take place?
Study locations
Leicester
How to take part
If you would like more information about taking part in research, please speak to your healthcare team about the options that are available to you.
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
GSKClinicalSupportHD@gsk.comThis study is supported by
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org