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).

Trial Profile

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2016

At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Biomarker; Registrational; Therapeutic Use
  • Acronyms BLISS-52
  • 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.
    • 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.
    • 28 May 2011 Pooled response sustainability data from this trial and BLISS-76 (see profile 700037974) presented at the 12th Annual Congress of the European League Against Rheumatism.
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