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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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Trial Profile

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: 05 Jan 2026

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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

  • 22 Dec 2025 According to a Johnson & Johnson media release, the European Commission (EC) has extended the marketing authorisation for Guselkumab as a subcutaneous treatment to treat moderate to severe plaque psoriasis (Pso) in children and adolescents from the age of 6 years who are candidates for systemic therapy. EC approval in adults living with moderate to severe plaque Pso in 2017.
  • 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 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.

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