A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE).

Trial Profile

A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE).

Completed
Phase of Trial: Phase II/III

Latest Information Update: 05 Mar 2018

At a glance

  • Drugs Atacicept (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms APRIL-Sle
  • Sponsors EMD Serono; Merck Serono
  • Most Recent Events

    • 08 Nov 2017 Results evaluating the exposure-response and exposure-safety relationships of atacicept in this and another trial (ADDRESS II) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 07 Jul 2016 Results of post hoc analysis assessing the relationship between treatment response, baseline biomarker levels and atacicept exposure in patients with systemic lupus erythematosus (SLE) published in the Arthritis and Rheumatology
    • 29 Oct 2013 Immunological results presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.
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