Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS).

Trial Profile

Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS).

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2016

At a glance

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

    • 04 Nov 2016 According to Amgen media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis based on the results of this trial and its open-label extension..
    • 10 Mar 2016 According to an Amgen media release, the US FDA has accepted for review the company's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 5 November 2016 for the ENBREL sBLA. The sBLA was submitted based on the results of this trial and its open-label extension.
    • 13 Sep 2010 Tolerability data from the withdrawal-retreatment period were published in the Journal of the American Academy of Dermatology.
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