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An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

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Trial Profile

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Jul 2024

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At a glance

  • Drugs Sarilumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacokinetics
  • Acronyms SKYPS
  • Sponsors Sanofi

    • Most Recent Events

    • 01 Feb 2024 According to a Sanofi media release, trial is under the pediatric investigation plan (PIP) and Submission is currently planned for 2027.
    • 31 Jan 2024 Planned End Date changed from 1 Apr 2027 to 19 Feb 2029.
    • 31 Jan 2024 Planned primary completion date changed from 29 Nov 2024 to 1 Apr 2026.

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