BENITIONSClinical Trial Intelligence

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Phase 2 Completed NCT01649765

ConditionSystemic Lupus Erythematosus
PhasePhase 2
SponsorGlaxoSmithKline
StatusCompleted
Enrollment93 participants
InterventionsBelimumab 10 mg/kg
Start dateSep 7, 2012
Completion dateJan 24, 2018
Results postedAug 15, 2018

Summary

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

Percentage of Participants With SLE Responder Index (SRI) Response at Week 52

Week 52 · Percentage of participants

Part A: Placebo43.6 Percentage of participants
Part A: Belimumab 10 mg/kg52.8 Percentage of participants
Odds Ratio (OR)1.49 (95% CI 0.64–3.46)

Open in BENITIONS View on ClinicalTrials.gov

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