← Back to all trials
Recruiting
NCT02991469
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
Conditions: Juvenile Idiopathic Arthritis
Sex: All
Ages: 1 Year – 17 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 51
Sponsor: Sanofi
Location: Investigational Site Number : 0320004 San Miguel de Tucumán Tucumán Province
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.
Eligibility Criteria
Inclusion criteria :
* Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, ≥6 to ≤17 years for Russia) at the time of the screening visit.
* Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria OR According to 2024 EULAR/PReS recommendation at Screening.
* Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator's judgment.
Exclusion criteria:
* Body weight \60 kg for patients enrolled in the ascending dose cohorts, then body weight \
Source: ClinicalTrials.gov (NCT02991469). StuddyBuddy aggregates publicly available trial information.
