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: 27 Sep 2017

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

    • 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.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top