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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Trial Profile

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2023

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At a glance

  • Drugs Abrocitinib (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms JADE TEEN
  • Sponsors Pfizer

Most Recent Events

  • 10 Feb 2023 According to Pfizer media release, the USFDA approved its supplemental New Drug Application (sNDA) for CIBINQO (abrocitinib), expanding its indication to include adolescents with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable, The CIBINQO prescribing information was updated to include data from this trial.
  • 01 Mar 2022 Results assessing the impact of abrocitinib on patient-reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate-to-severe atopic dermatitis in (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]), published in the Journal of the European Academy of Dermatology and Venereology.
  • 18 Aug 2021 Results assessing efficacy and safety of oral abrocitinib plus topical therapy in adolescents with moderate-to-severe AD, published in the JAMA Dermatology.

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