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A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus

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A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 12 Aug 2024

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At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Therapeutic Use
  • Acronyms EMBRACE; SLE EMBRACE
  • Sponsors GlaxoSmithKline; GSK; Human Genome Sciences

    • Most Recent Events

    • 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.
    • 03 Jun 2023 Data from five trials (BLISS-52 (NCT00424476), BLISS-76 (NCT00410384), BLISS-NEA (NCT01345253), BLISS-SC (NCT01484496), and EMBRACE (NCT01632241)) was used to evaluate predictor of neuropsychiatric flares in patients with systemic lupus erythromatosus under standard therapy (ST) with or without add-on belimumab, presented at the 24th Annual Congress of the European League Against Rheumatism.

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