A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Trial Profile

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms ADACCESS
  • Sponsors HEXAL; Novartis; Sandoz
  • Most Recent Events

    • 14 Sep 2017 Results published in a Sandoz Media Release.
    • 14 Sep 2017 According to a Sandoz media release, results from this study were presented at the 26th Congress of the European Academy of Dermatology and Venereology
    • 31 May 2017 According to a Sandoz media release, the European Medicines Agency (EMA) has accepted for regulatory review the Marketing Authorization Application (MAA) for adalimumab biosimilar (Humira). The submission included data from this trial and from other pharmacokinetic studies.
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