Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
Phase 4
Completed
NCT04908865
| Condition | Systemic Lupus Erythematosus |
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| Phase | Phase 4 |
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| Sponsor | GlaxoSmithKline |
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| Status | Completed |
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| Enrollment | 67 participants |
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| Interventions | Belimumab, Standard therapy |
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| Start date | Oct 21, 2021 |
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| Completion date | May 23, 2024 |
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| Results posted | Jul 23, 2025 |
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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
| Belimumab | 0 Participants |
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| Belimumab | 0 Participants |
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| Belimumab | 2 Participants |
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| Belimumab | 0 Participants |
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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
Open in BENITIONS
View on ClinicalTrials.gov
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