A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Trial Profile

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2017

At a glance

  • Drugs Dupilumab (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CHRONOS; LIBERTY AD CHRONOS
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 21 Jul 2017 According to a Sanofi and Regeneron Pharmaceuticals Inc media release, based on the data from SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS and CAFE studies the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Dupixent (dupilumab), for use in adults with moderate-to-severe atopic dermatitis.
    • 18 May 2017 Results published in the Lancet.
    • 28 Mar 2017 According to a Sanofi media release, the U.S.FDA has approved Dupixent (dupilumab) Injection for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable, based on the data from SOLO 1, SOLO 2 and CHRONOS trials (LIBERTY AD clinical program).
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