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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS 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-76
  • 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 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 Results of a post-hoc pooled analysis assessing predictors of renal flares in patients receiving treatment for active extra-renal SLE from following clinical trials: BLISS-52, BLISS-76, BLISS Northeast Asia, and BLISS-SC presented at the 24th Annual Congress of the European League Against Rheumatism

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