A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2017

At a glance

  • Drugs Guselkumab (Primary) ; Ustekinumab
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms NAVIGATE
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 23 Nov 2017 According to a Janssen Cilag media release, European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. European Marketing authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA, issued on 14 September 2017.
    • 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.
    • 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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