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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2024

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At a glance

  • Drugs Belimumab (Primary) ; Antimalarials; Corticosteroids; Immunosuppressants; Nonsteroidal anti-inflammatories
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms BLISS-SC
  • Sponsors GlaxoSmithKline; GSK; Human Genome Sciences
  • Most Recent Events

    • 12 Jan 2024 Results of post-hoc, pooled analysis from NCT00424476, NCT00410384, NCT01345253, NCT01484496, identifying predictors of renal flares in patients with SLE treated for active extra-renal disease, published in the Rheumatology
    • 15 Nov 2023 Results of post hoc pooled analysis from five trials: BLISS-76, BLISS-52, NEA, BLISS-SC, and EMBRACE presented at the ACR Convergence 2023
    • 15 Nov 2023 Results of post-hoc pooled analysis of 5 studies BLISS-76 (GSK study BEL110751); BLISS-52 (BEL110752); NEA (BEL113750); BLISS-SC (BEL112341); EMBRACE (BEL115471) assessing belimumab efficacy by race and ethnicity in patients with systemic lupus erythematosus, presented at the ACR Convergence 2023.
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