Belimumab
DrugBelimumab will be administered.
NCT Number: NCT06716606
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
GSK Investigational Site, Ciudad Autonoma Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
Exclusion criteria
Belimumab will be administered.
Time frame: Up to approximately 5 years
Time frame: Baseline (Day 1 of OLE study) and at Weeks 12, 26 and 52
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06574581
Connective Tissue Diseases, Interstitial Lung Disease
Taichung, Taiwan
View Trial DetailsNCT07541638
Connective Tissue Diseases, Interstitial Lung Disease
Roma, Italy
View Trial DetailsNCT07283081
Connective Tissue Diseases, Disease
Bordeaux, France
View Trial DetailsNCT06732674
Arthritis, Arthritis, Rheumatoid
Oslo, Norway
View Trial Details