Actively Recruiting

Phase 2
Age: 1Year - 17Years
All Genders
NCT02991469

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

Led by Sanofi · Updated on 2026-04-30

51

Participants Needed

31

Research Sites

649 weeks

Total Duration

On this page

Sponsors

S

Sanofi

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 31 locations

1

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, Argentina, T4000

Actively Recruiting

2

Investigational Site Number : 0320005

Buenos Aires, Argentina, 1023

Actively Recruiting

3

Investigational Site Number : 1240110

Calgary, Alberta, Canada, T3B 6A9

Actively Recruiting

4

Investigational Site Number : 2460040

Helsinki, Finland, 00029

Actively Recruiting

5

Investigational Site Number : 2500041

Bron, France, 69500

Actively Recruiting

6

Investigational Site Number : 2500042

Montpellier, France, 34295

Actively Recruiting

7

Investigational Site Number : 2500040

Paris, France, 75015

Actively Recruiting

8

Investigational Site Number : 2760064

Berlin, Germany, 13125

Actively Recruiting

9

Investigational Site Number : 2760065

Berlin, Germany, 13353

Actively Recruiting

10

Investigational Site Number : 2760062

Hamburg, Germany, 22081

Actively Recruiting

11

Investigational Site Number : 2760060

Sankt Augustin, Germany, 53757

Actively Recruiting

12

Investigational Site Number : 2760063

Sendenhorst, Germany, 48324

Completed

13

Investigational Site Number : 3000001

Athens, Greece, 115 27

Actively Recruiting

14

Investigational Site Number : 3000002

Thessaloniki, Greece, 546 42

Actively Recruiting

15

Investigational Site Number : 3720001

Crumlin, Dublin, Ireland, D12 N512

Actively Recruiting

16

Investigational Site Number : 3800051

Genoa, Genova, Italy, 16147

Actively Recruiting

17

Investigational Site Number : 3800054

Milan, Milano, Italy, 20122

Actively Recruiting

18

Investigational Site Number : 3800052

Rome, Roma, Italy, 00165

Actively Recruiting

19

Investigational Site Number : 6430001

Moscow, Russia, 115522

Completed

20

Investigational Site Number : 6430062

Moscow, Russia, 117997

Completed

21

Investigational Site Number : 6430063

Moscow, Russia, 119991

Completed

22

Investigational Site Number : 6430065

Ufa, Russia, 450083

Completed

23

Investigational Site Number : 7240055

Barcelona, Barcelona [Barcelona], Spain, 08035

Actively Recruiting

24

Investigational Site Number : 7240050

Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950

Actively Recruiting

25

Investigational Site Number : 7240053

Madrid, Spain, 28009

Actively Recruiting

26

Investigational Site Number : 7240056

Madrid, Spain, 28010

Actively Recruiting

27

Investigational Site Number : 7240054

Málaga, Spain, 29010

Actively Recruiting

28

Investigational Site Number : 7240051

Valencia, Spain, 46026

Actively Recruiting

29

Investigational Site Number : 8260031

London, London, City of, United Kingdom, WC1N 3JH

Completed

30

Investigational Site Number : 8260034

Leeds, United Kingdom, LS1 3EX

Actively Recruiting

31

Investigational Site Number : 8260033

Liverpool, United Kingdom, L12 2AP

Completed

Loading map...

Research Team

T

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here