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A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

StatusActive, Not Recruiting
PhasePhase 4
Started2024-06-06
View on ClinicalTrials.gov ↗
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable first-line SLE therapy.

Amendment history 4 changes detected by DataLookout

2026-09-02
Enrollment closed, study ongoing
2026-09-02
Final enrollment: 303 participants (planned 350)
2026-09-02
Trial sites reduced: 114 → 109 locations
2026-09-02
Completion pushed: 2029-05-29 → 2029-07-17
Trial Details
NCT Number NCT06411249
Lead Sponsor GlaxoSmithKline
Conditions Systemic Lupus Erythematosus
Enrollment 303 participants
Start Date 2024-06-06
Primary Completion 2027-06-29 (estimated)
Study Completion 2029-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-01