An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase. Name: SKYPS

Systemic Juvenile Idiopathic Arthritis (sJIA)

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

Number of Adverse events; Core treatment phase: Up to Week 12, Extension phase:Up to Week 162, Acceptability assessments (local tolerability); 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., Assessment 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. Population according to the 2001 ILAR classification. 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 individual JIA ACR components. Population according to the 2001 ILAR classification. 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). Population according to the 2001 ILAR classification. Core treatment phase: Up to Week 12 Extension phase: Up to Week 156., Assessment of participants with disease-related symptoms. Population according to the 2024 EULAR / PReS. At Week 4., Changes in IL-6 associated biomarkers. Population according to the 2001 ILAR classification and the 2024 EULAR / PReS. Up to week 12.

No related papers found yet.

Bulgaria, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Portugal, Spain