Long-term safety and efficacy of belimumab in adults with systemic sclerosis associated ILD
Research type
Research Study
Full title
An open label study to investigate the long-term safety and efficacy of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
IRAS ID
1010298
Contact name
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
.Systemic sclerosis (SSc) is a rare disease in which the immune system attacks the body’s own cells which are then replaced by
permanent scar tissue. SSc can cause thickened skin, problems with blood circulation, and internal organ problems. Interstitial lung
disease (ILD) is a complication of SSc which causes inflammation and scar tissue to form in the lungs.
This study will test a drug called Belimumab, the drug works by blocking the action of a particular protein called BLyS which may be
involved in the development and worsening of SSc.
This study is an open label extension (OLE) study of an ongoing randomized clinical study (218224) where participants received either Belimumab or placebo. Eligible participants who completed the 218224 study and may benefit from treatment with Belimumab will be invited to join the OLE study. The purpose of the OLE study is to test whether Belimumab, in addition to standard therapy, is safe and effective in slowing down the progression of ILD and other organ problems, and improves the quality of life of people with SSc ILD when taken over a longer period of time.
The study will involve about 195-225 participants with SSc ILD aged 18 years or older, approximately 5 patients will be in the UK. It will
last for approximately 5 years for each patient which includes 5 years of treatment, and follow-up for 8 weeks.
Belimumab is given as an injection under the skin. Participants in the OLE will receive Belimumab 200mg once weekly for 5 years in
addition to continuing with their usual SSc medications.
Tests undertaken will include, but are not limited to, blood tests (including optional genetic test to identify markers in specific genes),
urine tests, physical exams, lung function tests, lung CT scans, Electrocardiogram (ECG), vital signs, optional skin biopsy.
Participants will also complete questionaires about their quality of life.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0630
Date of REC Opinion
4 Nov 2024
REC opinion
Further Information Favourable Opinion