RecruitingPhase 2NCT02991469

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

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

Sponsor

Sanofi

Enrollment

51 participants

Start Date

Aug 9, 2018

Study Type

INTERVENTIONAL

Conditions

Juvenile Idiopathic Arthritis

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

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This dose-finding study tests the safety and correct dose of sarilumab — a drug that blocks an inflammatory protein called IL-6 — in children and teenagers with systemic juvenile idiopathic arthritis (sJIA), a form of childhood arthritis that causes whole-body inflammation including fever and rash. You may be eligible if: - You are between 1 and 17 years old - You have been diagnosed with systemic JIA according to established criteria - Standard treatments have not worked well enough and you are considered a candidate for a biologic medication You may NOT be eligible if: - You weigh less than 10 kg - You have had severe systemic symptoms or macrophage activation syndrome (MAS) in the past 6 months - You have interstitial lung disease or pulmonary hypertension - You have previously been treated with tocilizumab, sarilumab, or other anti-IL-6 drugs - You are pregnant or breastfeeding - You have active tuberculosis or certain other active infections - You have severe cardiac disease related to sJIA Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution Route of administration: Subcutaneous

Locations(31)

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 1240110

Calgary, Alberta, Canada

Investigational Site Number : 2460040

Helsinki, Finland

Investigational Site Number : 2500041

Bron, France

Investigational Site Number : 2500042

Montpellier, France

Investigational Site Number : 2500040

Paris, France

Investigational Site Number : 2760064

Berlin, Germany

Investigational Site Number : 2760065

Berlin, Germany

Investigational Site Number : 2760062

Hamburg, Germany

Investigational Site Number : 2760060

Sankt Augustin, Germany

Investigational Site Number : 2760063

Sendenhorst, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000002

Thessaloniki, Greece

Investigational Site Number : 3720001

Crumlin, Dublin, Ireland

Investigational Site Number : 3800051

Genoa, Genova, Italy

Investigational Site Number : 3800054

Milan, Milano, Italy

Investigational Site Number : 3800052

Rome, Roma, Italy

Investigational Site Number : 6430001

Moscow, Russia

Investigational Site Number : 6430062

Moscow, Russia

Investigational Site Number : 6430063

Moscow, Russia

Investigational Site Number : 6430065

Ufa, Russia

Investigational Site Number : 7240055

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240050

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Investigational Site Number : 7240053

Madrid, Spain

Investigational Site Number : 7240056

Madrid, Spain

Investigational Site Number : 7240054

Málaga, Spain

Investigational Site Number : 7240051

Valencia, Spain

Investigational Site Number : 8260031

London, London, City of, United Kingdom

Investigational Site Number : 8260034

Leeds, United Kingdom

Investigational Site Number : 8260033

Liverpool, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02991469

Related Trials

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

NCT0377396580 locations

Feasibility of a Diet Intervention for Juvenile Arthritis

NCT064745467 locations

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

NCT048334651 location

Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis

NCT0751757514 locations

Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

NCT072437821 location