A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Guselkumab (Primary) ; Adalimumab
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms VOYAGE 2
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 12 Oct 2017 Results (n=1543) of pooled patient data from VOYAGE 1,VOYAGE 2 and NAVIGATE studies comparing efficacy of Guselkumab versus Ustekinumab, presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 22 Sep 2017 Results (n=1829) of pooled analysis of VOYAGE 1 and VOYAGE 2 studies assessing efficacy published in the British Journal of Dermatology.
    • 15 Sep 2017 Based on the data from VOYAGE 1, VOYAGE 2 and NAVIGATE studies, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation in the European Union for the use of guselkumab in the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy, as reported in a Janssen media release. A final decision from the European Commission (EC) is expected later this year.
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