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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-09

Study Completion Date

2029-02-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sarilumab SAR153191 (REGN88)

Intervention Type DRUG

Pharmaceutical form: Solution

Route of administration: Subcutaneous

Interventions

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Sarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution

Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Liverpool, , United Kingdom

Site Status COMPLETED

Countries

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Bulgaria Chile Czechia Estonia Netherlands Poland United States Argentina Canada Finland France Germany Ireland Italy Russia Spain United Kingdom

Central Contacts

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

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Other Identifiers

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DRI13926

Identifier Type: -

Identifier Source: org_study_id

U1111-1177-3584

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-512701-11

Identifier Type: REGISTRY

Identifier Source: secondary_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Sarilumab

Sarilumab SAR153191 (REGN88)

Interventions

Sarilumab SAR153191 (REGN88)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Regeneron Pharmaceuticals

Sanofi

Responsible Party

Principal Investigators

Clinical Sciences & Operations

Locations

Investigational Site Number : 0320004

Investigational Site Number : 1240110

Investigational Site Number : 2460040

Investigational Site Number : 2500041

Investigational Site Number : 2500042

Investigational Site Number : 2500040

Investigational Site Number : 2760064

Investigational Site Number : 2760065

Investigational Site Number : 2760062

Investigational Site Number : 2760060

Investigational Site Number : 2760063

Investigational Site Number : 3720001

Investigational Site Number : 3800051

Investigational Site Number : 3800054

Investigational Site Number : 3800052

Investigational Site Number : 6430001

Investigational Site Number : 6430062

Investigational Site Number : 6430063

Investigational Site Number : 6430065

Investigational Site Number : 7240055

Investigational Site Number : 7240050

Investigational Site Number : 7240053

Investigational Site Number : 7240056

Investigational Site Number : 7240054

Investigational Site Number : 7240051

Investigational Site Number : 8260031

Investigational Site Number : 8260034

Investigational Site Number : 8260033

Countries

Central Contacts

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

Related Links

Other Identifiers

DRI13926

U1111-1177-3584

2024-512701-11