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).
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History