What is sarilumab studying for systemic juvenile idiopathic arthritis?

Sarilumab is being studied to understand how it works in children and adolescents with systemic juvenile idiopathic arthritis (sJIA). Researchers want to find the right dose and see how the drug affects the disease and safety over a long period. This research is sponsored by Sanofi to help improve treatment options for young patients with sJIA.

Who may be eligible for this juvenile idiopathic arthritis clinical trial?

Children and adolescents between 1 and 17 years old with systemic juvenile idiopathic arthritis who have not responded well to current treatments may be eligible. Both males and females can participate. Some restrictions apply, such as body weight limits and prior use of certain medications. Please review eligibility criteria for more details.

Is there any cost to participate in this juvenile idiopathic arthritis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants and their families should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 1Year - 17Years

All Genders

ID02991469

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

Led by Sanofi · Updated on 2026-05-22

Participants Needed

Research Sites

150 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of sarilumab, a drug given by injection, in children and adolescents aged 1 to 17 years who have systemic juvenile idiopathic arthritis sJIA. The study aims to understand how the drug behaves in the body, its effects, and its long-term safety for treating this condition. This trial is a phase 2, open-label study sponsored by Sanofi, designed to find the best dose and treatment schedule for young patients with sJIA. Participants will receive sarilumab injections under the skin at doses that increase during the study based on body weight. The treatment includes a 12-week core phase where patients receive the drug, followed by a 144-week extension phase for continued treatment. After completing treatment, a 6-week follow-up period will monitor patients. The study includes careful dose adjustments and long-term observation to assess the drugs impact. Throughout the study, participants will undergo various assessments including blood tests to measure drug levels, evaluations of disease activity using scales like the Investigator Global Assessment and ParentPatient Global Assessment, and tracking of symptoms and medication use. Safety will be monitored continuously by recording any side effects or local reactions to injections. The total participation time is about 166 weeks, during which the researchers will collect data on how well sarilumab works and how safe it is for children and adolescents with sJIA.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Male and female patients aged 1 to 17 years (or country-specific age requirement) at screening
Diagnosis of systemic juvenile idiopathic arthritis (sJIA) according to ILAR 2001 criteria or 2024 EULAR/PReS recommendation
Inadequate response to current treatment and candidate for biologic disease modifying anti-rheumatic drug (DMARD) as judged by investigator

You will not qualify if you...

Body weight less than 10 kg or more than 60 kg for dose cohorts
Uncontrolled severe systemic symptoms or macrophage activation syndrome (MAS) within 6 months prior to screening
History of or ongoing interstitial lung disease, pulmonary hypertension, or pulmonary alveolar proteinosis
NSAIDs dose stable for less than 2 weeks prior to baseline or dosing outside approved label
Non-biologic DMARD dose stable for less than 6 weeks prior to baseline or exceeding recommended dose
Oral glucocorticoid dose exceeding prednisone 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-IL-6 or IL-6 receptor antagonist therapies
Treatment with any biologic for sJIA within 5 half-lives prior to first sarilumab dose
Treatment with Janus kinase inhibitor or growth hormone within 4 weeks prior to first sarilumab dose
Treatment with investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline
Exclusion related to tuberculosis or other infections
Live attenuated vaccine within 4 weeks prior to baseline
History of systemic hypersensitivity to biologic drugs or product constituents
Laboratory abnormalities at screening
Severe cardiac disease due to sJIA
Pregnant or breast-feeding female adolescents

Research Team

Trial Transparency email recommended (Toll free for US & Canada)

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