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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2025

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At a glance

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

Most Recent Events

  • 29 Sep 2025 According to a Johnson & Johnson media release, company announced the that the U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab), Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from TREMFYA PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2 and PROTOSTAR.
  • 02 Dec 2024 According to a Johnson & Johnson media release, company announced the submission of supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) based on data from the Phase 3 PROTOSTAR and from the Phase 3 VOYAGE 1 and 2 studies.
  • 26 Sep 2023 Results of post-hoc analysis evaluating the efficacy and safety of guselkumab in the Asian subpopulation of VOYAGE 1 and VOYAGE 2 through 5 years, published in the Dermatology and Therapy

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