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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)

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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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

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

    • Most Recent Events

    • 27 Feb 2020 Post hoc analysis results evaluating the treat-to-target (T2T) endpoints, published in the Rheumatology
    • 24 Oct 2018 Results of integrated non-clinical and clinical data to determine an appropriate atacicept dose for a Phase 3 (P3) study; NCT00624338 and NCT01972568, presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 24 Oct 2018 Results of post-hoc analysis of data from ADDRESS II and its long-term extension describing 48-week low disease activity and remission rates, presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.

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