Actively Recruiting
An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous Injection, in Children and Adolescents Aged 1 to 17 Years With Systemic Juvenile Idiopathic Arthritis, Followed by an Extension Phase
Led by Sanofi · Updated on 2026-05-22
51
Participants Needed
32
Research Sites
150 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of sarilumab, a drug given by injection, in children and adolescents aged 1 to 17 years who have systemic juvenile idiopathic arthritis (sJIA). The study aims to understand how the drug behaves in the body, its effects, and its long-term safety for treating this condition. This trial is a phase 2, open-label study sponsored by Sanofi, designed to find the best dose and treatment schedule for young patients with sJIA. Participants will receive sarilumab injections under the skin at doses that increase during the study based on body weight. The treatment includes a 12-week core phase where patients receive the drug, followed by a 144-week extension phase for continued treatment. After completing treatment, a 6-week follow-up period will monitor patients. The study includes careful dose adjustments and long-term observation to assess the drug's impact. Throughout the study, participants will undergo various assessments including blood tests to measure drug levels, evaluations of disease activity using scales like the Investigator Global Assessment and Parent/Patient Global Assessment, and tracking of symptoms and medication use. Safety will be monitored continuously by recording any side effects or local reactions to injections. The total participation time is about 166 weeks, during which the researchers will collect data on how well sarilumab works and how safe it is for children and adolescents with sJIA.
CONDITIONS
Brief 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...
- Male and female patients aged 1 to 17 years (or country-specific age requirement) at screening
- Diagnosis of systemic juvenile idiopathic arthritis (sJIA) according to ILAR 2001 criteria or 2024 EULAR/PReS recommendation
- Inadequate response to current treatment and candidate for biologic disease modifying anti-rheumatic drug (DMARD) as judged by investigator
You will not qualify if you...
- Body weight less than 10 kg or more than 60 kg for dose cohorts
- Uncontrolled severe systemic symptoms or macrophage activation syndrome (MAS) within 6 months prior to screening
- History of or ongoing interstitial lung disease, pulmonary hypertension, or pulmonary alveolar proteinosis
- NSAIDs dose stable for less than 2 weeks prior to baseline or dosing outside approved label
- Non-biologic DMARD dose stable for less than 6 weeks prior to baseline or exceeding recommended dose
- Oral glucocorticoid dose exceeding prednisone 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-IL-6 or IL-6 receptor antagonist therapies
- Treatment with any biologic for sJIA within 5 half-lives prior to first sarilumab dose
- Treatment with Janus kinase inhibitor or growth hormone within 4 weeks prior to first sarilumab dose
- Treatment with investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline
- Exclusion related to tuberculosis or other infections
- Live attenuated vaccine within 4 weeks prior to baseline
- History of systemic hypersensitivity to biologic drugs or product constituents
- Laboratory abnormalities at screening
- Severe cardiac disease due to sJIA
- Pregnant or breast-feeding female adolescents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks for core treatment phase, followed by 144 weeks for extension phase
Participants receive sarilumab by subcutaneous injection during the core treatment phase, followed by an extension treatment phase.
Visits occur throughout the 12-week core treatment phase and the 144-week extension phase; specific visit frequency varies
Duration - 6 weeks
Participants are monitored for 6 weeks after treatment ends to assess safety and ongoing health status.
1 follow-up visit
Trial Site Locations
Total: 32 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 : 6200003
Lisbon, Portugal, 1150-199
Actively Recruiting
20
Investigational Site Number : 6430001
Moscow, Russia, 115522
Completed
21
Investigational Site Number : 6430062
Moscow, Russia, 117997
Completed
22
Investigational Site Number : 6430063
Moscow, Russia, 119991
Completed
23
Investigational Site Number : 6430065
Ufa, Russia, 450083
Completed
24
Investigational Site Number : 7240055
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
25
Investigational Site Number : 7240050
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
26
Investigational Site Number : 7240053
Madrid, Spain, 28009
Actively Recruiting
27
Investigational Site Number : 7240056
Madrid, Spain, 28010
Actively Recruiting
28
Investigational Site Number : 7240054
Málaga, Spain, 29010
Actively Recruiting
29
Investigational Site Number : 7240051
Valencia, Spain, 46026
Actively Recruiting
30
Investigational Site Number : 8260031
London, London, City of, United Kingdom, WC1N 3JH
Completed
31
Investigational Site Number : 8260034
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
32
Investigational Site Number : 8260033
Liverpool, United Kingdom, L12 2AP
Completed
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
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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