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: 15 Sep 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

    • 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.
    • 13 Jul 2017 According to a Janssen Biotech media release, the US FDA approved TREMFYA (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval was based on on results from VOYAGE 1, VOYAGE 2 and NAVIGATE studies.
    • 03 Mar 2017 According to a Janssen Research & Development media release, results from the study are being presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting.
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