A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) (SKYPS)

May 20, 2026 updated by: Sanofi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1023
        • Recruiting
        • Investigational Site Number : 0320005
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Recruiting
        • Investigational Site Number : 0320004
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A9
        • Recruiting
        • Investigational Site Number : 1240110
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Investigational Site Number : 2460040
  • France
      • Bron, France, 69500
        • Recruiting
        • Investigational Site Number : 2500041
      • Montpellier, France, 34295
        • Recruiting
        • Investigational Site Number : 2500042
      • Paris, France, 75015
        • Recruiting
        • Investigational Site Number : 2500040
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Investigational Site Number : 2760064
      • Berlin, Germany, 13353
        • Recruiting
        • Investigational Site Number : 2760065
      • Hamburg, Germany, 22081
        • Recruiting
        • Investigational Site Number : 2760062
      • Sankt Augustin, Germany, 53757
        • Recruiting
        • Investigational Site Number : 2760060
      • Sendenhorst, Germany, 48324
        • Completed
        • Investigational Site Number : 2760063
  • Greece
      • Athens, Greece, 115 27
        • Recruiting
        • Investigational Site Number : 3000001
      • Thessaloniki, Greece, 546 42
        • Recruiting
        • Investigational Site Number : 3000002
  • Ireland
    • Dublin
      • Crumlin, Dublin, Ireland, D12 N512
        • Recruiting
        • Investigational Site Number : 3720001
  • Italy
    • Genova
      • Genoa, Genova, Italy, 16147
        • Recruiting
        • Investigational Site Number : 3800051
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Investigational Site Number : 3800054
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Investigational Site Number : 3800052
  • Portugal
      • Lisbon, Portugal, 1150-199
        • Recruiting
        • Investigational Site Number : 6200003
  • Russia
      • Moscow, Russia, 115522
        • Completed
        • Investigational Site Number : 6430001
      • Moscow, Russia, 119991
        • Completed
        • Investigational Site Number : 6430063
      • Moscow, Russia, 117997
        • Completed
        • Investigational Site Number : 6430062
      • Ufa, Russia, 450083
        • Completed
        • Investigational Site Number : 6430065
  • Spain
      • Madrid, Spain, 28009
        • Recruiting
        • Investigational Site Number : 7240053
      • Madrid, Spain, 28010
        • Recruiting
        • Investigational Site Number : 7240056
      • Málaga, Spain, 29010
        • Recruiting
        • Investigational Site Number : 7240054
      • Valencia, Spain, 46026
        • Recruiting
        • Investigational Site Number : 7240051
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Investigational Site Number : 7240055
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Recruiting
        • Investigational Site Number : 7240050
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Investigational Site Number : 8260034
      • Liverpool, United Kingdom, L12 2AP
        • Completed
        • Investigational Site Number : 8260033
    • London, City of
      • London, London, City of, United Kingdom, WC1N 3JH
        • Completed
        • Investigational Site Number : 8260031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  • 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.

Exclusion criteria:

  • Body weight <10 kg or >60 kg for patients enrolled in the ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose.
  • Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening.
  • History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.
  • If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.
  • If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
  • If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline.
  • Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
  • Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
  • Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
  • Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
  • Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
  • Exclusion related to tuberculosis.
  • Exclusion criteria related to past or current infection other than tuberculosis.
  • Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment.
  • Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
  • Laboratory abnormalities at the screening visit (identified by the central laboratory).
  • Severe cardiac disease due to sJIA.
  • Pregnant or breast-feeding female adolescent patients.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Sarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution

Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of PK parameter: maximum serum concentration observed (Cmax)
Time Frame: Up to Week 12
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
Up to Week 12
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
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
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
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
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
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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: At Week 4
Population according to the 2024 EULAR / PReS
At Week 4
Changes in IL-6 associated biomarkers
Time Frame: Up to Week 12
Population according to the 2001 ILAR classification and the 2024 EULAR / PReS
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

January 17, 2031

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimated)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI13926
  • U1111-1177-3584 (Registry Identifier: ICTRP)
  • 2024-512701-11 (Registry Identifier: CTIS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juvenile Idiopathic Arthritis

Clinical Trials on Sarilumab SAR153191 (REGN88)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe