An Open-label Ascending Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

STATUS

Recruiting
participants needed

100
sponsor

Sanofi

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Updated on 19 February 2024

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anti-rheumatic drugs

arthritis

rheumatoid factor

disease modifying antirheumatic drugs

antirheumatic

sarilumab

Summary

Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population

Secondary Objective:

To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.

Description

For approximately 72 patients enrolled in the dose-finding and second portions, 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. For approximately 28 patients enrolled in the third portion, the total study duration per patient will be 106 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 84-week extension phase, and a 6-week post-treatment follow-up.

Details

Condition	JUVENILE RHEUMATOID ARTHRITIS, Arthritis, arthritis and arthritic pain, arthritis and arthritic pain (pediatric), arthritis and arthritic pain (pediatric), arthritis and arthritic pain
Age	2-17 years
Treatment	Sarilumab
Clinical Study Identifier	NCT02776735
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Male and female patients aged 2 and 17 years (or country specified age requirement) at the time of the screening visit
	Diagnosis of rheumatoid factor-negative or rheumatoid factor positive polyarticular Juvenile Idiopathic Arthritis (JIA) subtype or oligoarticular extended JIA subtype according to the International League of Associations for Rheumatology (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with at least 5 active joints as per American College of Rheumatology (ACR) definition for "active arthritis" at Screening
	Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying antirheumatic drug (DMARD) as per investigator's judgment
Exclusion Criteria
	Body weight <10 kg or >60 kg for patients enrolled in the 3 ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose-regimen
	If nonsteroidal anti-inflammatory drugs (NSAIDs) [including cyclo oxygenase-2 inhibitors (COX-2)] taken, dose stable for <2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label
	If non-biologic DMARD taken, dose stable for <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 0.5 mg/kg/day (or 30 mg/day) within 2 weeks 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 pcJIA within 5 half-lives prior to the first dose of sarilumab
	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
	Lipid lowering drug stable for less than 6 weeks prior to screening
	Exclusion related to tuberculosis (TB)
	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)
	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

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Study Definition

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An Open-label Ascending Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)