A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE).
Phase of Trial: Phase III
Latest Information Update: 15 Nov 2017
At a glance
- Drugs Belimumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- Acronyms BLISS-SC
- Sponsors Human Genome Sciences
- 15 Nov 2017 According to a GlaxoSmithKline media release, based on the data of this trial, the European Commission has approved a new subcutaneous (SC) formulation of Benlysta (belimumab), as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus(SLE) with a high degree of disease activity despite standard therapy. This approval is for a single-dose prefilled syringe and a single-dose prefilled pen presentation, administered as a once weekly injection of 200mg.
- 08 Nov 2017 Results assessing the effects of belimumab on corticosteroid use presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
- 07 Nov 2017 According to a GlaxoSmithKline media release, data from this trial is being presented at the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History