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

Inclusion criteria :

• Male and female patients aged ≥1 and ≤17 years (or country specified agerequirement, 12-17 years for Russia) at the time of the screening visit.

• Diagnosis of systemic JIA subtype according to the International Associationsagainst Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) ClassificationCriteria with the following features:

• 5 active joints at screening or

• 2 active joints at screening with systemic JIA fever >37.5 0C in the 3 dayspreceding baseline or for at least 3 out of any 7 consecutive days duringscreening despite glucocorticoids at a dose stable for at least 3 days.

• Patient with an inadequate response to current treatment and considered as acandidate for a biologic disease modifying anti rheumatic drug (DMARD) as perinvestigator'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, pulmonaryalveolar proteinosis.

• If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baselinevisit and/or dosing prescribed outside of approved label.

• If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baselinevisit 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 priorto baseline.

• Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonisttherapies, including but not limited to tocilizumab or sarilumab.

• Treatment with any biologic treatment for sJIA within 5 half-lives prior to thefirst dose of sarilumab (the required off treatment periods and procedures may varyaccording to local requirements).

• Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose ofsarilumab; and treatment with growth hormone within 4 weeks prior to the first doseof sarilumab (the required off treatment periods and procedures may vary accordingto local requirements).

• Treatment with any investigational biologic or non-biologic product within 8 weeksor 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 asvaricella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may bepermitted based on the Investigator's judgment.

• Exclusion related to history of a systemic hypersensitivity reaction to any biologicdrug and known hypersensitivity to any constituent of the product.

• Laboratory abnormalities at the screening visit (identified by the centrallaboratory).

• 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.