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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)

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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: 23 Jul 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

    • 15 Jun 2024 Results (n=796) to determine SLE patient endotypes according to B cell immunophenotype and serological profile and assess their response to belimumab presented at the 25th Annual Congress of the European League Against Rheumatism
    • 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

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