What next?
What next?
About this study
Systemic Sclerosis (SSc), also known as scleroderma, is an autoimmune disorder causing inflammation and scarring (fibrosis) that can affect different organs. Around 50% of people with SSc develop Interstitial Lung Disease (ILD) or SSc-ILD.
This study will look to see if a new drug, called belimumab, helps with lung function and if there is any other impact on skin thickening and general symptoms that can impact quality of life.
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?
The study will involve you being assigned to one of two groups. One group will be given the study drug, Belimumab, along with their standard treatment. The second group will be given a placebo, which looks just like the study drug, but does not contain any of the medication.
You will be asked to take the medication each day for up to one year.
Summary of involvement
Study duration up to 1 year
Assigned to one of two groups:
Group 1 will take Belimumab
Group 2 will take a placebo
Can I take part?
You may be able to take part if you are aged 18 years and over, and have a diagnosis of Systemic Sclerosis Associated Interstitial Lung 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 list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
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 our more about other research opportunities visit our research finder main page.
Aged 18 years and over
Diagnosis of Systemic Sclerosis Associated Interstitial Lung Disease
You must have an area of skin that would be suitable to have an injection in the tummy area or upper thigh
There is also a set criteria for lung function requirements, but this will be discussed with the research team
Diagnosis of a rheumatic autoimmune disease that is not Systemic Sclerosis
Pulmonary arterial hypertension
Obstructive pulmonary disease
Use of antifibrotic medications within the last 4 weeks
Previous or planned organ or bone marrow transplant
Pregnant or breastfeeding women
What difference could taking part make?
Taking part in this study would enable researchers to see if the study drug is helpful for people diagnosed with SSc-ILD.
Taking part in research has the potential to make a difference for people who have SSc-ILD now and for future generations.
Where does the study take place?
Study locations
Edgbaston
Leeds
London
You may still be able to take part in the study if you do not live close to the study locations, however, travel will be a requirement. This will not affect the standard care that you receive for your condition.
How to take part
Please speak to your medical team about taking part, or contact the research team directly, to express your interests.
Further information
The summary on this page 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
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org