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

NCT02991469 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI13926U1111-1177-35842024-512701-11
• Study Type: interventional
• Target: 51
• Locations: 11 countries
• Sites: 31

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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (1)

Sarilumab

EXPERIMENTAL

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)

Interventions

Sarilumab SAR153191 (REGN88) DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Sarilumab

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Laboratory abnormalities at the screening visit (identified by the central laboratory).
• Severe cardiac disease due to sJIA.
• Pregnant or breast-feeding female adolescent patients.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (31)

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

RECRUITING

Investigational Site Number : 0320005

Buenos Aires, 1023, Argentina

RECRUITING

Investigational Site Number : 1240110

Calgary, Alberta, T3B 6A9, Canada

RECRUITING

Investigational Site Number : 2460040

Helsinki, 00029, Finland

RECRUITING

Investigational Site Number : 2500041

Bron, 69500, France

RECRUITING

Investigational Site Number : 2500042

Montpellier, 34295, France

RECRUITING

Investigational Site Number : 2500040

Paris, 75015, France

RECRUITING

Investigational Site Number : 2760064

Berlin, 13125, Germany

RECRUITING

Investigational Site Number : 2760065

Berlin, 13353, Germany

RECRUITING

Investigational Site Number : 2760062

Hamburg, 22081, Germany

RECRUITING

Investigational Site Number : 2760060

Sankt Augustin, 53757, Germany

RECRUITING

Investigational Site Number : 2760063

Sendenhorst, 48324, Germany

COMPLETED

Investigational Site Number : 3000001

Athens, 115 27, Greece

RECRUITING

Investigational Site Number : 3000002

Thessaloniki, 546 42, Greece

RECRUITING

Investigational Site Number : 3720001

Crumlin, Dublin, D12 N512, Ireland

RECRUITING

Investigational Site Number : 3800051

Genoa, Genova, 16147, Italy

RECRUITING

Investigational Site Number : 3800054

Milan, Milano, 20122, Italy

RECRUITING

Investigational Site Number : 3800052

Rome, Roma, 00165, Italy

RECRUITING

Investigational Site Number : 6430001

Moscow, 115522, Russia

COMPLETED

Investigational Site Number : 6430062

Moscow, 117997, Russia

COMPLETED

Investigational Site Number : 6430063

Moscow, 119991, Russia

COMPLETED

Investigational Site Number : 6430065

Ufa, 450083, Russia

COMPLETED

Investigational Site Number : 7240055

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240050

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

RECRUITING

Investigational Site Number : 7240053

Madrid, 28009, Spain

RECRUITING

Investigational Site Number : 7240056

Madrid, 28010, Spain

RECRUITING

Investigational Site Number : 7240054

Málaga, 29010, Spain

RECRUITING

Investigational Site Number : 7240051

Valencia, 46026, Spain

RECRUITING

Investigational Site Number : 8260031

London, London, City of, WC1N 3JH, United Kingdom

COMPLETED

Investigational Site Number : 8260034

Leeds, LS1 3EX, United Kingdom

RECRUITING

Investigational Site Number : 8260033

Liverpool, L12 2AP, United Kingdom

COMPLETED

Related Links

• DRI13926 Plain Language Results Summary

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-Us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: December 13, 2016
• Study Start: August 9, 2018
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): January 17, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

GR (2); ES (6); CA (1); IT (3); FI (1); AR (2); IE (1); DE (5); RU (4); FR (3); GB (3)