NCT04908865

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

A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Belimumab	Belimumab will be administered.
DRUG	Standard therapy	Standard therapy will be continued.

Timeline

• Start date: 2021-10-21
• Primary completion: 2024-05-23
• Completion: 2024-08-13
• First posted: 2021-06-01
• Last updated: 2025-07-23
• Results posted: 2025-07-23

Locations

9 sites across 1 country: China