A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Trial Profile

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to 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 Liberty AD Solo; SOLO 2
  • 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.
    • 01 Jun 2017 Pooled results (n=1379) from 2 randomized, phase 3 trials (NCT02277743 and NCT02277769) published in the Dermatology and Therapy
    • 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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