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: 19 Jul 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

    • 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.
    • 03 Mar 2017 Primary endpoint has been met. (The number of visits at which participants achieve an Investigators Global Assessment (IGA) response of 0 or 1 and at least a 2 grade improvement (from Week 16) among randomized participants with an inadequate (IGA2) response to ustekinumab at Week 16), according to a Janssen Research & Development media release.
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