An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD)
GlaxoSmithKline
Summary
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria: * Discontinuation of study medication during study 218224 or 221672 for any reason. * Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh. * Participant is capable and willing…
Interventions
- DrugBelimumab
Belimumab will be administered.
Locations (10)
- GSK Investigational SitePhiladelphia, Pennsylvania
- GSK Investigational SiteCiudad Autonoma Buenos Aires
- GSK Investigational SiteCiudad Autonoma de Buenos Aire
- GSK Investigational SiteBeijing
- GSK Investigational SiteZhuzhou
- GSK Investigational SiteLarissa