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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2024

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At a glance

  • Drugs Guselkumab (Primary) ; Adalimumab
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms VOYAGE 1
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 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.
  • 07 Oct 2023 Results of the 5-year post hoc analysis comparing baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model, published in the American Journal of Clinical Dermatology
  • 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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