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A Phase 3 Randomized Withdrawal, Double-blind, Placebo-controlled, Multi-center Study Investigating The Efficacy And Safety Of Pf-04965842 In Subjects Aged 12 Years And Over, With Moderate To Severe Atopic Dermatitis With The Option Of Rescue Treatment In Flaring Subjects

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Trial Profile

A Phase 3 Randomized Withdrawal, Double-blind, Placebo-controlled, Multi-center Study Investigating The Efficacy And Safety Of Pf-04965842 In Subjects Aged 12 Years And Over, With Moderate To Severe Atopic Dermatitis With The Option Of Rescue Treatment In Flaring Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 May 2023

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At a glance

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

    • Most Recent Events

    • 27 Apr 2023 Results of post hoc analysis assessing (n=1227) the response maintenance (efficacy and safety) with continuous-/reduced-dose abrocitinib or withdrawal and response to treatment reintroduction after flare in adolescent and adult participants, published in the Journal of Dermatological Treatment.
    • 28 Feb 2022 Results of a post hoc analysis assessed the efficacy of rescue therapy presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 10 Dec 2021 According to a Pfizer media release, the European Commission has approved the 100 mg and 200 mg doses of Cibinqo (abrocitinib), for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate and severe renal impairment or certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19.
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