BLISSc-ILD: Can a new drug, Belimumab, help people with systemic sclerosis associated interstitial lung disease

Upcoming study
Expected to open September 2023
This study is currently recruiting
Expected to close February 2027
This study is closed
This study closed in February 2027
We will update this page with study results when available.
Information on study results are included below
This study closed in February 2027
Ask your healthcare team about taking part in research

What next?

Original listing:

What next?

Original listing:

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 investigate whether a new drug belimumab can help reduce lung function decline and change to skin thickening and other symptoms that can impact quality of life.

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What is involved?

You will be 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 (SSc-ILD).

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 research 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.

You may be able to join this study if all of these apply:

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

Additional lung function requirements. These will be discussed with you by the research team

You will not be able to join the study if any of the following applies:

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.

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

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.com

This study is supported by

GlaxoSmithKline
Study ID number:
NCT05878717

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