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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, Lymphostat-B), a fully human monoclonal anti-BLyS [LymphoStat-B; Human Genome Sciences] antibody, in subjects with systemic lupus erythematosus (SLE)

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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, Lymphostat-B), a fully human monoclonal anti-BLyS [LymphoStat-B; Human Genome Sciences] antibody, in subjects with systemic lupus erythematosus (SLE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2024

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At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms BLISS-52
  • Sponsors 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 pooled analysis of 4 studies (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; N=2968) assessing patient-reported outcomes in patients with neuropsychiatric SLE (NPSLE) in comparison to SLE patients without neuropsychiatric involvement, were 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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