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Available in the Gosset platform where reported.
01
Overview
Phase 4, open-label, single-arm trial of belimumab in systemic lupus erythematosus (SLE), sponsored by GSK. Primary endpoint: Lupus Low Disease Activity State at 52 weeks. Started Jun 2024; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Belimumab (GSK1550188)
Participants will receive GSK1550188 subcutaneously.
03
Who it enrols
Adults with early, active, autoantibody-positive systemic lupus erythematosus (SLE) despite stable first-line therapy, without severe active CNS lupus, active lupus nephritis, or significant comorbidities.
04
Endpoints
Primary
Lupus Low Disease Activity State
Secondary
SLE Responder Index 4
Lupus Low Disease Activity State Duration
Average Oral Prednisone Equivalent Dose <= 5 mg/day
Severe Flare defined as modified SELENA-SLEDAI Flare Index (SFI)
Cutaneous Lupus Disease Area and Severity Index Activity Score
Functional Assessment of Chronic Illness Therapy - Fatigue
Adverse Events
Definition of Remission in SLE Remission
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Competitive context
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