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A 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) (BLISSconneCTD-OLE)
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2024-12-12
Completion Date
2029-12-27
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Belimumab
Belimumab will be administered.
Locations (10)
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site
Beijing, China
GSK Investigational Site
Zhuzhou, China
GSK Investigational Site
Larissa, Greece
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Yongsan-Ku Seoul, South Korea
GSK Investigational Site
London, United Kingdom