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: 27 Sep 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

    • 27 Sep 2017 According to a GlaxoSmithKline media release, belimumab (Benlysta) has been approved for the treatment of adult patients with systemic lupus erythematosus (SLE) bu the Japanese Ministry of Health, Labour and Welfare (MHLW) based on results from four trials (Northeas Asia, BLISS-SC, BLISS-52 and BLISS-76).
    • 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.
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