- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991469
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: For site information, send an email with site number to
- Email: Contact-Us@sanofi.com
Study Locations
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Tucumán
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San Miguel de Tucumán, Tucumán, Argentina, T4000AXL
- Recruiting
- Investigational Site Number : 0320004
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Plovdiv, Bulgaria, 4000
- Recruiting
- Investigational Site Number : 1000001
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Recruiting
- Investigational Site Number : 1240110
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Quebec
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Montreal, Quebec, Canada, H3T1C5
- Recruiting
- Investigational Site Number : 1240112
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Helsinki, Finland, 00029 HUS
- Recruiting
- Investigational Site Number : 2460040
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Bron, France, 69500
- Recruiting
- Investigational Site Number : 2500041
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Montpellier, France, 34295
- Recruiting
- Investigational Site Number : 2500042
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Paris, France, 75015
- Recruiting
- Investigational Site Number : 2500040
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Berlin, Germany, 13125
- Recruiting
- Investigational Site Number : 2760064
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Berlin, Germany, 13353
- Recruiting
- Investigational Site Number : 2760065
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Bremen, Germany, 28205
- Recruiting
- Investigational Site Number : 2760061
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Hamburg, Germany, 22081
- Recruiting
- Investigational Site Number : 2760062
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Sankt Augustin, Germany, 53757
- Recruiting
- Investigational Site Number : 2760060
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Sendenhorst, Germany, 48324
- Completed
- Investigational Site Number : 2760063
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Dublin, Ireland, D12 N512
- Recruiting
- Investigational Site Number : 3720001
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Genova, Italy, 16147
- Recruiting
- Investigational Site Number : 3800051
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Milano, Italy, 20121
- Recruiting
- Investigational Site Number : 3800054
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Roma, Italy
- Recruiting
- Investigational Site Number : 3800052
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Moscow, Russian Federation, 115522
- Recruiting
- Investigational Site Number : 6430001
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Moscow, Russian Federation, 117198
- Completed
- Investigational Site Number : 6430062
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Moscow, Russian Federation, 119991
- Recruiting
- Investigational Site Number : 6430063
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Ufa, Russian Federation, 450083
- Recruiting
- Investigational Site Number : 6430065
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Madrid, Spain, 28009
- Recruiting
- Investigational Site Number : 7240053
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Valencia, Spain, 46026
- Recruiting
- Investigational Site Number : 7240051
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Catalunya [Cataluña]
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Esplugues de Llobregat, Catalunya [Cataluña], Spain, 08950
- Recruiting
- Investigational Site Number : 7240050
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Madrid, Comunidad De
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Madrid, Madrid, Comunidad De, Spain, 28046
- Recruiting
- Investigational Site Number : 7240052
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Leeds, United Kingdom, LS1 3EX
- Recruiting
- Investigational Site Number : 8260034
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Liverpool, United Kingdom, L12 2AP
- Completed
- Investigational Site Number : 8260033
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London, City Of
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London, London, City Of, United Kingdom, WC1N 3JH
- Recruiting
- Investigational Site Number : 8260031
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria :
- Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, 12-17 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 with the following features:
- 5 active joints at screening or
- 2 active joints at screening with systemic JIA fever >37.5 0C in the 3 days preceding baseline or for at least 3 out of any 7 consecutive days during screening despite glucocorticoids at a dose stable for at least 3 days.
- 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
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 |
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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.
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Pharmaceutical form: Solution Route of administration: Subcutaneous |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Assessment of PK parameter: maximum serum concentration observed (Cmax)
Time Frame: Up to Week 12
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Up to Week 12
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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
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Up to Week 12
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Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Time Frame: Up to Week 12
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Up to Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of patients with adverse events
Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
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Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
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Number of patients with local site reactions
Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
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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
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR component: Physician's global assessment of disease activity
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: Number of joints with active arthritis
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: Number of joints with limitation of motion
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in JIA ACR Component: fever
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS)
Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
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Changes in glucocorticoid use
Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
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Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
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Changes in IL-6 associated biomarkers: IL6
Time Frame: Up to Week 12
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Up to Week 12
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Changes in IL-6 associated biomarkers: sIL-6R
Time Frame: Up to Week 12
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Up to Week 12
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Proportion of patients receiving glucocorticoids by dose category (glucocorticoid equivalent prednisone dose ≥0.5 mg/kg, ≥0.2 mg/kg and <0.5 mg/kg, <0.2 mg/kg)
Time Frame: At weeks 24, 48, and every 24 weeks up to Week 156
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At weeks 24, 48, and every 24 weeks up to Week 156
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Proportion of patients free of glucocorticoids and without JIA flare
Time Frame: At weeks 24, 48, and every 24 weeks up to Week 156
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At weeks 24, 48, and every 24 weeks up to Week 156
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRI13926
- 2015-004000-35 (EudraCT Number)
- U1111-1177-3584 (Registry Identifier: ICTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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