NCT05917288

A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab	Belimumab will be administered
DRUG	Standard of care	Standard of care will be administered

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2023-06-23
• Last updated: 2025-11-14
• Results posted: 2025-11-14

Locations

6 sites across 1 country: China