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A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis

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Trial Profile

A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Secukinumab (Primary) ; Etanercept
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 29 Jun 2023 Status changed from active, no longer recruiting to completed.
    • 12 Jun 2023 Results assessing the pooled safety of secukinumab up to 52 weeks from two studies (NCT03668613 and NCT02471144) in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials (NCT01365455, NCT01636687, NCT01358578, NCT01555125), published in the American Journal of Clinical Dermatology.
    • 14 Apr 2023 This trial has been discontinued in Poland and Spain (End Date: 30 Mar 2023), according to European Clinical Trials Database record
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