BENITIONSClinical Trial Intelligence

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Phase 4 Completed NCT04908865

ConditionSystemic Lupus Erythematosus
PhasePhase 4
SponsorGlaxoSmithKline
StatusCompleted
Enrollment67 participants
InterventionsBelimumab, Standard therapy
Start dateOct 21, 2021
Completion dateMay 23, 2024
Results postedJul 23, 2025

Summary

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.

Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52

Up to Week 52 · Participants

Belimumab0 Participants
Belimumab0 Participants
Belimumab2 Participants
Belimumab0 Participants

Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score

Baseline (Day 0) and Week 52 · Participants

Belimumab44 Participants

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