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

STATUS

Recruiting
End date

Apr 23, 2027
participants needed

72
sponsor

Sanofi

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Updated on 23 October 2022

See if I qualify

glucocorticoids

treatment regimen

arthritis

biologics

rheumatic diseases

DMARD

anti-rheumatic drugs

rheumatism

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.

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.

Details

Condition	Juvenile Idiopathic Arthritis
Treatment	Sarilumab SAR153191 (REGN88)
Clinical Study Identifier	NCT02991469
Sponsor	Sanofi
Last Modified on	23 October 2022

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Eligibility		Yes	No	Not Sure
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
	active joints at screening or
	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

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Study Definition

Wikipedia

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