At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 enrolled
Drug / intervention
Belimumab 10 mg/kg +1 moredrug
Likely dose
Belimumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating Belimumab 10 mg/kg and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 93 participants across 32 sites in 10 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Canada, Japan, Mexico, Peru, Poland, Russia, Spain, United Kingdom, United States
CollaboratorsHuman Genome Sciences Inc., a GSK Company
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartSep 2012
Primary CompletionJan 2018
Study CompletionSep 2025
TodayJul 2026
First PostedJul 25, 2012
Enrollment StartSep 7, 2012
Primary CompletionJan 24, 2018
Study CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.9 years ago
Interventions
Belimumab 10 mg/kgdrug
Belimumab was administered.
Placeboother
Placebo was administered