Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2021

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top