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)

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2017

At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms BLISS-76
  • Sponsors Human Genome Sciences
  • Most Recent Events

    • 18 Mar 2016 Pooled post-hoc analysis of BLISS-52 and BLISS-76 trials (n=1125) were published in the Arthritis and Rheumatology.
    • 30 Oct 2013 Pooled analysis of parent and extension studies which assessed changes in levels of B cells and IgG presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.
    • 05 Jun 2012 Results will be presented at the 13th Annual Congress of the European League Against Rheumatism, according to a Human Genome Sciences media release.
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