🏛️ Verified NIH Record • Updated 2026-05-20

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) (NCT02991469)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population. Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (19 items).

Location: Investigational Site Number : 0320004 — San Miguel de Tucumán, Tucumán Province

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion criteria:
  • Body weight \<10 kg or \>60 kg for patients enrolled in the ascending dose cohorts, then body weight \<10 kg for patients subsequently enrolled at the selected dose.
  • Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening.
  • History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
  • If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors \[COX-2\]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.
  • If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
  • If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline.
  • Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
  • Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
  • Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
  • Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
  • Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (32 Sites)

  • Investigational Site Number : 0320004 — San Miguel de Tucumán, Tucumán Province
  • Investigational Site Number : 0320005 — Buenos Aires,
  • Investigational Site Number : 1240110 — Calgary, Alberta
  • Investigational Site Number : 2460040 — Helsinki,
  • Investigational Site Number : 2500041 — Bron,
  • Investigational Site Number : 2500042 — Montpellier,
  • Investigational Site Number : 2500040 — Paris,
  • Investigational Site Number : 2760064 — Berlin,
  • Investigational Site Number : 2760065 — Berlin,
  • Investigational Site Number : 2760062 — Hamburg,
  • Investigational Site Number : 2760060 — Sankt Augustin,
  • Investigational Site Number : 2760063 — Sendenhorst,
  • Investigational Site Number : 3000001 — Athens,
  • Investigational Site Number : 3000002 — Thessaloniki,
  • Investigational Site Number : 3720001 — Crumlin, Dublin
  • Investigational Site Number : 3800051 — Genoa, Genova
  • Investigational Site Number : 3800054 — Milan, Milano
  • Investigational Site Number : 3800052 — Rome, Roma
  • Investigational Site Number : 6200003 — Lisbon,
  • Investigational Site Number : 6430001 — Moscow,
  • Investigational Site Number : 6430062 — Moscow,
  • Investigational Site Number : 6430063 — Moscow,
  • Investigational Site Number : 6430065 — Ufa,
  • Investigational Site Number : 7240055 — Barcelona, Barcelona [Barcelona]
  • Investigational Site Number : 7240050 — Esplugues de Llobregat, Barcelona [Barcelona]

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗