Actively Recruiting
Long-term Study of Belimumab Treatment in Adults with Interstitial Lung Disease from Systemic Sclerosis or Other Connective Tissue Diseases
Led by GlaxoSmithKline · Updated on 2025-12-09
514
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effects of belimumab in adults with interstitial lung disease ILD linked to systemic sclerosis SSc and other connective tissue diseases CTD. This open-label extension study builds on previous randomized controlled trials to see if belimumab can continue to slow lung function decline, disease progression, and improve quality of life in these patients. Participants in this study will receive belimumab as the investigational treatment. The study continues from prior trials, focusing on long-term use and tolerance. Participants will be monitored over time to assess how well belimumab is tolerated and its impact on lung function and overall disease status. During the study, researchers will track adverse events, including serious and special interest events, for up to approximately five years. They will also measure changes in lung function using forced vital capacity FVC at multiple time points baseline, 12, 26, and 52 weeks. Participants will undergo regular assessments to monitor safety, disease progression, and quality of life throughout the study period.
CONDITIONS
Brief Title
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)
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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