A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Trial Profile

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Jan 2018

At a glance

  • Drugs Atacicept (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Therapeutic Use
  • Acronyms ADDRESS-II
  • Sponsors EMD Serono; Merck KGaA
  • Most Recent Events

    • 08 Nov 2017 Results evaluating the exposure-response and exposure-safety relationships of atacicept in this and another trial (APRIL-SLE) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 08 Nov 2017 Results (n=158) of a post-hoc analysis assessing attainment of low disease activity by ADDRESS II patients who started with high disease activity, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 08 Nov 2017 Cumulative safety results from this and the long term extension trial (NCT02070978) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
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