A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Registration Number
- NCT02991469
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sarilumab Sarilumab SAR153191 (REGN88) Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase.
- Primary Outcome Measures
Name Time Method Assessment of PK parameter: maximum serum concentration observed (Cmax) Up to Week 12 Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough) Up to Week 12 Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t) Up to Week 12
- Secondary Outcome Measures
Name Time Method Number of patients with local site reactions Core treatment phase: Up to Week 12. Extension phase: Up to Week 156 Number of patients with adverse events Core treatment phase: Up to Week 12. Extension phase: Up to Week 162 Change from baseline in JIA ACR Component: Number of joints with limitation of motion Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP) Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS) Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Changes in glucocorticoid use Core treatment phase: Up to Week 12. Extension phase: Up to Week 156 Changes in IL-6 associated biomarkers: IL6 Up to Week 12 Changes in IL-6 associated biomarkers: sIL-6R Up to Week 12 Change from baseline in JIA ACR Component: fever Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in JIA ACR component: Physician's global assessment of disease activity Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Change from baseline in JIA ACR Component: Number of joints with active arthritis Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Proportion of patients receiving glucocorticoids by dose category (glucocorticoid equivalent prednisone dose ≥0.5 mg/kg, ≥0.2 mg/kg and <0.5 mg/kg, <0.2 mg/kg) At weeks 24, 48, and every 24 weeks up to Week 156 Proportion of patients free of glucocorticoids and without JIA flare At weeks 24, 48, and every 24 weeks up to Week 156
Trial Locations
- Locations (27)
Investigational Site Number : 0320004
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Investigational Site Number : 1000001
🇧🇬Plovdiv, Bulgaria
Investigational Site Number : 1240110
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240112
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 2500041
🇫🇷Bron, France
Investigational Site Number : 2500042
🇫🇷Montpellier, France
Investigational Site Number : 2760064
🇩🇪Berlin, Germany
Investigational Site Number : 2760065
🇩🇪Berlin, Germany
Investigational Site Number : 2460040
🇫🇮Helsinki, Finland
Investigational Site Number : 2500040
🇫🇷Paris, France
Investigational Site Number : 2760062
🇩🇪Hamburg, Germany
Investigational Site Number : 2760060
🇩🇪Sankt Augustin, Germany
Investigational Site Number : 2760063
🇩🇪Sendenhorst, Germany
Investigational Site Number : 3720001
🇮🇪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 : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430062
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430063
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430065
🇷🇺UFA, Russian Federation
Investigational Site Number : 7240050
🇪🇸Esplugues de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240053
🇪🇸Madrid, 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