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

NCT02991469 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

Sarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2028-03-01
Completion
2031-01-17
FDA Drug
Yes

Countries

  • Argentina
  • Canada
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Portugal
  • Russia
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02991469 on ClinicalTrials.gov