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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jan 2024

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At a glance

  • Drugs Epratuzumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBODY-1
  • Sponsors UCB

    • Most Recent Events

    • 15 Nov 2023 Results of post hoc analysis (from studies NCT01262365; n=249, NCT01261793; n=263 and NCT02804763; n=43) assessing Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE presented at the ACR Convergence 2023
    • 29 Jul 2021 Results (n=1202) of data from two trials (EMBODY™-1 and EMBODY™-2), assessing whether SLE patients follow distinct disease activity trajectories within a clinical trial setting and to identify factors associated with individual trajectories, published in the Arthritis Research and Therapy
    • 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

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