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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
514
Belimumab will be administered.
GSK Investigational Site
Philadelphia, Pennsylvania, United States
RECRUITINGGSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
RECRUITINGGSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
RECRUITINGGSK Investigational Site
Beijing, China
RECRUITINGGSK Investigational Site
Zhuzhou, China
RECRUITINGGSK Investigational Site
Larissa, Greece
RECRUITINGGSK Investigational Site
Hokkaido, Japan
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITINGGSK Investigational Site
Yongsan-Ku Seoul, South Korea
RECRUITINGGSK Investigational Site
London, United Kingdom
RECRUITINGNumber of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs)
Time frame: Up to approximately 5 years
Change from Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline (Day 1 of OLE study) and at Weeks 12, 26 and 52
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