A Phase 2 interventional study of Sarilumab SAR153191 (REGN88) in Juvenile Idiopathic Arthritis, sponsored by Sanofi. Recruiting at 40 sites in 14 countries. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
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.
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.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 51 is close to the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution Route of administration: Subcutaneous
Assessment of PK parameter: maximum serum concentration observed (Cmax)
Time frame: 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)
Time frame: Up to Week 12
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Time frame: Up to Week 12
Number of patients with adverse events
Time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
Proportion of participants with local reactions after injection
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Systemic Juvenile Arthritis Disease Activity Score-10 (sJADAS-10)
Population according to the 2001 ILAR classification
Time frame: 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 disease-related symptoms
Population according to the 2024 EULAR / PReS
Time frame: At Week 4
Changes in IL-6 associated biomarkers
Population according to the 2001 ILAR classification and the 2024 EULAR / PReS
Time frame: Up to Week 12
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Started Aug 2018 (actual). Primary completion is estimated for Mar 2028, 114 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sarilumab