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Finding the right dose of sarilumab for children with systemic juvenile idiopathic arthritis

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

Phase 2 Interventional Sanofi · NCT02991469

This study is testing the right dose of sarilumab to see how well it works and how safe it is for children and teens with systemic juvenile idiopathic arthritis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment51 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionstocilizumab, sarilumab, prednisone
Locations31 sites (San Miguel de Tucumán, Tucumán Province and 30 other locations)
Trial IDNCT02991469 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the appropriate dosage and treatment regimen of sarilumab for children and adolescents aged 1-17 years diagnosed with systemic juvenile idiopathic arthritis (sJIA). The study will assess the pharmacokinetic and pharmacodynamic profiles of the medication, as well as its efficacy and long-term safety over a total duration of 166 weeks, which includes a screening phase, a core treatment phase, and an extension phase. Participants will be monitored for their response to treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents aged 1-17 years with a diagnosis of systemic juvenile idiopathic arthritis who have not responded adequately to current treatments.

Not a fit: Patients who weigh less than 10 kg or more than 60 kg may not benefit from this study due to exclusion criteria.

Why it matters

Potential benefit: If successful, this study could provide a tailored treatment option for children suffering from systemic juvenile idiopathic arthritis, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using biologic DMARDs for treating juvenile idiopathic arthritis, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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 \<10 kg or \>60 kg for patients enrolled in the ascending dose cohorts, then body weight \<10 kg for patients subsequently enrolled at the selected dose.
* Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening.
* History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
* If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors \[COX-2\]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.
* If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
* If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 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-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
* Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
* Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
* Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
* Exclusion related to tuberculosis.
* Exclusion criteria related to past or current infection other than tuberculosis.
* Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment.
* Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
* Laboratory abnormalities at the screening visit (identified by the central laboratory).
* Severe cardiac disease due to sJIA.
* Pregnant or breast-feeding female adolescent patients.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

San Miguel de Tucumán, Tucumán Province and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Juvenile Idiopathic Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.