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A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Pf-04965842 Monotherapy In Subjects Aged 12 Years And Older, With Moderate To Severe Atopic Dermatitis

Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Pf-04965842 Monotherapy In Subjects Aged 12 Years And Older, With Moderate To Severe Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2020

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At a glance

  • Drugs Abrocitinib (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms JADE Mono-1
  • Sponsors Pfizer
  • Most Recent Events

    • 11 Nov 2020 According to a Pfizer media release, complete results from the study had been published in The Lancet in July 2020.
    • 27 Oct 2020 According to an Pfizer media release,the European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population with a decision anticipated in the second half of 2021
    • 27 Oct 2020 According to an Pfizer media release, U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the companys New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once daily Janus kinase 1 inhibitor, for the treatment of moderate to severe atopic dermatitis in patients 12 and older. The FDA is expected to make a decision in April 2021.The filings were based on the results of JADE MONO-1, JADE MONO-2 and JADE COMPARE
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