drugset / Trial / NCT02991469

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

NCT02991469

Phase 2 Recruiting 51 enrolled Sanofi Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-08-09
Primary completion
2028-03-01
Completion
2031-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Sarilumab Monoclonal antibody Subcutaneous