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: 27 Jul 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

    • 21 Jul 2017 According to a GlaxoSmithKline media release, based on the data of this trial, the US FDA has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy.
    • 17 Jun 2017 Results of 6 month open label extension study presented at the 18th Annual Congress of the European League Against Rheumatism
    • 24 Jan 2017 Results assessing safety and efficacy published in the Arthritis and Rheumatology.
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