RECRUITING
Phase 2
ClinicalTrials.gov
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
Sponsor: Sanofi • ClinicalTrials.gov ID: NCT02991469
Registry updated: 2026-10-19
Ad
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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.
Interventions
-
Sarilumab SAR153191 (REGN88)
(Drug)
Pharmaceutical form: Solution Route of administration: Subcutaneous
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 \<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.
Conditions
Juvenile Idiopathic Arthritis
Locations
- 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 : 3000004 — Athens, Greece
- Investigational Site Number : 3000003 — Athens, Greece
- Investigational Site Number : 3000002 — Thessaloniki, Greece
- Investigational Site Number : 3480001 — Budapest, Hungary
- 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 : 4840004 — Mérida, Yucatán, Mexico
- Investigational Site Number : 4840001 — Mexico City, Mexico
- Investigational Site Number : 6200003 — Lisbon, Portugal
- Investigational Site Number : 6200005 — Lisbon, Portugal
- Investigational Site Number : 6200001 — Lisbon, Portugal
- 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 : 7240050 — Esplugues de Llobregat, Barcelona [Barcelona], Spain
- Investigational Site Number : 7240055 — Barcelona, Catalunya [Cataluña], Spain
- Investigational Site Number : 7240056 — Chamberí, Madrid, Comunidad de, Spain
- Investigational Site Number : 7240058 — Madrid, Spain
- Investigational Site Number : 7240054 — Málaga, Spain
- Investigational Site Number : 7240057 — Sabadell, 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
Sponsored
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record