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).

Trial Profile

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).

Completed
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
  • Most Recent Events

    • 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 improvement in multiple organ domains presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 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
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