At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Belimumab (biological), Placebo (other)
- How long the study runs
- Study runs about 73 months (dates as stated)
- About the drug or intervention
- Belimumab — biological: Belimumab will be administered. · Placebo — other: .Placebo will be administered.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-09-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for systemic sclerosis associated interstitial lung disease
- • Phase2/Phase3 - 300 participants
- • This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with systemic sclerosis associated interstitial lung disease
Where?
- • Wakefield - GSK Investigational Site
- • Birmingham - GSK Investigational Site
- • Leeds - GSK Investigational Site
- • London - GSK Investigational Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participant is 18 years of age inclusive, or older at the time of signing the agreement to take part.
- ✓Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism...
- ✓Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \>0 over at least one skin area proximal...
- ✓Total mRSS ≥15 on Day 1.
- ✓Evidence of interstitial lung disease on centrally read screening HRCT.
Who cannot take part
- ✗FVC ≤45% of predicted, or a DLco (corrected for red blood cell level) ≤40% of predicted or requiring supplemental oxygen at...
- ✗lung arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
- ✗SSc kidney crisis within 6 months prior to the first day of dosing (Day 1).
- ✗Obstructive lung disease (pre-bronchodilator FEV1/FVC \<0.7).
- ✗Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
See the full criteria
Where Is This Study? (5 UK sites)
GSK Investigational Site
Wakefield WF1 4DG, United Kingdom
GSK Investigational Site
Birmingham B15 2GW, United Kingdom
GSK Investigational Site
Leeds LS7 4SA, United Kingdom
GSK Investigational Site
London NW3 2QG, United Kingdom
GSK Investigational Site
Portsmouth SG1 4AB, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
