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
- 51
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: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t) Up to Week 12 Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough) Up to Week 12
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events Core treatment phase: Up to Week 12. Extension phase: Up to Week 162 Proportion of participants with local reactions after injection Core treatment phase: Up to Week 12. Extension phase: Up to Week 156 Proportion of participants with Investigator Global Assessment (IGA) of disease activity below a defined value on 1-100 VAS scale Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Proportion of participants with Parent / patient Global Assessment (PGA) of well-being below a defined value on 1-100 VAS scale Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Proportion of participants with clinically inactive disease (CID) 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: 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 Population according to the 2001 ILAR classification
Change from baseline in individual JIA ACR components Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Population according to the 2001 ILAR classification
Change from baseline in Systemic Juvenile Arthritis Disease Activity Score-10 (sJADAS-10) Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156 Population according to the 2001 ILAR classification
Assessment of participants with disease-related symptoms At Week 4 Population according to the 2024 EULAR / PReS
Changes in IL-6 associated biomarkers Up to Week 12 Population according to the 2001 ILAR classification and the 2024 EULAR / PReS
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 : 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
Scroll for more (17 remaining)Investigational Site Number : 0320004🇦🇷San Miguel de Tucumán, Tucumán, Argentina