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A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2023

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At a glance

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

    • Most Recent Events

    • 06 Apr 2023 Results of pooled analysis from Phase 2/3 studies (X-PLORE, VOYAGE 1, VOYAGE 2, NAVIGATE, ORION, ECLIPSE, Japan registration) assessing guselkumab safety in patients with psoriasispublished in the British Journal of Dermatology
    • 21 Mar 2023 Results assessing the relative PASI improvement from baseline over the early phase of treatment among GUS-treated subjects from VOYAGE 1 (n=329), VOYAGE 2 (n=496), ORION (n=62), and ECLIPSE (n=534) trials, presented at the American Academy of Dermatology annual Meeting 2023.
    • 01 Mar 2020 Primary endpoint (Number of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16) has been met, according to results published in the Journal of Dermatological Treatment
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