A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease.

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jul 2018

At a glance

  • Drugs Epratuzumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBODY-2
  • Sponsors UCB
  • Most Recent Events

    • 30 Jan 2018 Results of a post-hoc analysis assessing the efficacy of Epratuzumab in Systemic Lupus Erythematosus Patients with Associated Sjogren's Syndrome from two trials (EMBODY 1 and EMBODY 2; n=113) published in the Arthritis and Rheumatology
    • 06 Sep 2016 Results from this and EMBODY-1 (profile 56330) published in the Arthritis and Rheumatology.
    • 19 Aug 2015 According to an Immunomedics media release, this trial did not meet the primary efficacy end point for either doses.
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