A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

Trial Profile

A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 28 Jul 2017 Long-term results of patients who were re-randomised at week 16 (n=308) published in the British Journal of Dermatology
    • 23 Mar 2017 According to an Amgen media release, Approval from the European Commission (EC) grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
    • 23 Mar 2017 According to an Amgen media release, the European Commission (EC) has granted marketing authorization for AMGEVITA™ in all available indications. The EC also approved AMGEVITA for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
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