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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 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) 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 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Oct 2024

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At a glance

  • Drugs Sarilumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Acronyms SKYPP
  • Sponsors Sanofi

Most Recent Events

  • 11 Jun 2024 According to a Regeneron Pharmaceuticals media release, company announced that U.S. FDA has approved Kevzara (sarilumab) for the treatment of patients with active polyarticular juvenile idiopathic arthritis based on evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJI (NCT01146652 , NCT01061736 & NCT02776735)
  • 16 Feb 2024 Status changed from active, no longer recruiting to completed.
  • 14 Feb 2024 This trial has been completed in Estonia (Global end date: 27 Dec 2023).

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