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A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (≥6 To <18 Years of Age)

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A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (≥6 To <18 Years of Age)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2025

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At a glance

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

    • Most Recent Events

    • 02 Dec 2024 According to a Johnson & Johnson media release, company announced the submission of upplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for the treatment of children 5 years of age and older with active juvenile psoriatic arthritis (jPsA) based on PK extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and TREMFYA efficacy and safety data from the PROTOSTAR study.
    • 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.
    • 05 Dec 2023 Planned End Date changed from 2 Jun 2025 to 18 Dec 2026.

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