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: 28 Sep 2017

At a glance

  • Drugs Dupilumab (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms Liberty AD Solo 1; SOLO 1
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 28 Sep 2017 According to a Sanofi and Regeneron Pharmaceuticals media release, based on the data from LIBERTY AD studies including SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE and CAFE the European Commission has granted marketing authorization for Dupixent (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
    • 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
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