Actively Recruiting
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
Eligibility Criteria
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.
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
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
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
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