GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Trial Profile

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 May 2017

At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 13 Feb 2017 Planned End Date changed from 1 Mar 2019 to 1 Jan 2018.
    • 13 Dec 2016 According to a Glaxo Laboratories India media release, company has submitted a new drug regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy, based on results Northeast Asia and BLISS-SC trials.
    • 14 Nov 2016 According to GlaxoSmithKline Media Release, Data in Japan, China and South Korea will form basis of new regulatory submissions for Benlysta (Belimumab).
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