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
Who is this study for? Child to young adult patients with Juvenile Idiopathic Arthritis
What treatments are being studied? Sarilumab
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Argentina
Investigational Site Number : 0320004
RECRUITING
San Miguel De Tucumán
Bulgaria
Investigational Site Number : 1000001
RECRUITING
Plovdiv
Canada
Investigational Site Number : 1240110
RECRUITING
Calgary
Investigational Site Number : 1240112
RECRUITING
Montreal
Finland
Investigational Site Number : 2460040
RECRUITING
Helsinki
France
Investigational Site Number : 2500041
RECRUITING
Bron
Investigational Site Number : 2500042
RECRUITING
Montpellier
Investigational Site Number : 2500040
RECRUITING
Paris
Germany
Investigational Site Number : 2760064
RECRUITING
Berlin
Investigational Site Number : 2760065
RECRUITING
Berlin
Investigational Site Number : 2760062
RECRUITING
Hamburg
Investigational Site Number : 2760060
RECRUITING
Sankt Augustin
Investigational Site Number : 2760063
COMPLETED
Sendenhorst
Ireland
Investigational Site Number : 3720001
RECRUITING
Crumlin
Italy
Investigational Site Number : 3800051
RECRUITING
Genoa
Investigational Site Number : 3800054
RECRUITING
Milan
Investigational Site Number : 3800052
RECRUITING
Rome
Russian Federation
Investigational Site Number : 6430001
COMPLETED
Moscow
Investigational Site Number : 6430062
COMPLETED
Moscow
Investigational Site Number : 6430063
COMPLETED
Moscow
Investigational Site Number : 6430065
COMPLETED
Ufa
Spain
Investigational Site Number : 7240055
RECRUITING
Barcelona
Investigational Site Number : 7240050
RECRUITING
Esplugues De Llobregat
Investigational Site Number : 7240053
RECRUITING
Madrid
Investigational Site Number : 7240056
RECRUITING
Madrid
Investigational Site Number : 7240054
RECRUITING
Málaga
Investigational Site Number : 7240051
RECRUITING
Valencia
United Kingdom
Investigational Site Number : 8260034
RECRUITING
Leeds
Investigational Site Number : 8260033
COMPLETED
Liverpool
Investigational Site Number : 8260031
COMPLETED
London
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-Us@sanofi.com
800-633-1610
Time Frame
Start Date:2018-08-09
Estimated Completion Date:2029-02-19
Participants
Target number of participants:51
Treatments
Experimental: Sarilumab
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.