Belimumab in adults with systemic sclerosis associated with ILD
Research type
Research Study
Full title
A Phase 2/3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
IRAS ID
1007407
Contact name
Negin Hashemi
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2023-503219-14
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.
The purpose of the 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.
The study will involve about 300 participants with SSc ILD aged 18years or older, approximately 6 patients will be in the UK. It will last for 66 weeks for each patient which includes a 6 week screening period, 52 weeks of treatment, and follow-up for 8 weeks.
Belimumab is given as an injection under the skin. Participants will be randomly assigned to 1 of 2 different treatment groups in addition to continuing with their usual SSc medications.
Belimumab 200mg once weekly for 52 weeks
or
Placebo once weekly for 52 weeks
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.
Patients who complete the study and are not classed as a treatment failure will be offered to join a 52 week extension study where all participants will receive Belimumab 200mg injection once weekly.REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0473
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion