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