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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02776735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Argentina, Canada, Chile, Czechia, Finland, France, Germany, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Idiopathic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Sarilumab

Participants will receive one of three ascending dose regimens of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose regimen once this is identified. Sarilumab will be given during 12-week core treatment phase followed by an extension treatment phase (144 weeks for approximately 72 patients enrolled in dose-finding and second portions and 84 weeks for approximately 28 patients enrolled in third portion)

Interventions

Drug: - Sarilumab

Pharmaceutical form:Solution Route of administration: Subcutaneous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site Number 8400416, Los Angeles, California

Status

Recruiting

Address

Investigational Site Number 8400416

Los Angeles, California, 90027

International Sites

Investigational Site Number 0320060, Caba, Argentina

Status

Recruiting

Address

Investigational Site Number 0320060

Caba, , C1270AAN

Investigational Site Number 0320004, San Miguel de Tucuman, Argentina

Status

Recruiting

Address

Investigational Site Number 0320004

San Miguel de Tucuman, , T4000AXL

Investigational Site Number 1240110, Calgary, Canada

Status

Recruiting

Address

Investigational Site Number 1240110

Calgary, , T3B 6A8

Investigational Site Number 1240112, Montréal, Canada

Status

Recruiting

Address

Investigational Site Number 1240112

Montréal, , H3T1C5

Investigational Site Number 1520016, Concepcion, Chile

Status

Completed

Address

Investigational Site Number 1520016

Concepcion, ,

Investigational Site Number 2030041, Brno, Czechia

Status

Recruiting

Address

Investigational Site Number 2030041

Brno, , 62500

Investigational Site Number 2460040, Helsinki, Finland

Status

Recruiting

Address

Investigational Site Number 2460040

Helsinki, , 00029 HUS

Investigational Site Number 2500040, Paris, France

Status

Recruiting

Address

Investigational Site Number 2500040

Paris, , 75015

Investigational Site Number 2760064, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number 2760064

Berlin, , 13125

Investigational Site Number 2760061, Bremen, Germany

Status

Recruiting

Address

Investigational Site Number 2760061

Bremen, , 28205

Investigational Site Number 2760062, Hamburg, Germany

Status

Recruiting

Address

Investigational Site Number 2760062

Hamburg, , 22081

Investigational Site Number 2760060, Sankt Augustin, Germany

Status

Recruiting

Address

Investigational Site Number 2760060

Sankt Augustin, , 53757

Investigational Site Number 2760063, Sendenhorst, Germany

Status

Recruiting

Address

Investigational Site Number 2760063

Sendenhorst, , 48324

Investigational Site Number 3800051, Genova, Italy

Status

Recruiting

Address

Investigational Site Number 3800051

Genova, , 16147

Investigational Site Number 3800053, Milano, Italy

Status

Recruiting

Address

Investigational Site Number 3800053

Milano, , 20122

Investigational Site Number 3800052, Roma, Italy

Status

Recruiting

Address

Investigational Site Number 3800052

Roma, ,

Investigational Site Number 4840061, Guadalajara, Mexico

Status

Active, not recruiting

Address

Investigational Site Number 4840061

Guadalajara, , 44620

Investigational Site Number 4840060, Monterrey, Mexico

Status

Completed

Address

Investigational Site Number 4840060

Monterrey, , 64460

Investigational Site Number 5280020, Utrecht, Netherlands

Status

Completed

Address

Investigational Site Number 5280020

Utrecht, , 3584 EA

Investigational Site Number 6160074, Bydgoszcz, Poland

Status

Active, not recruiting

Address

Investigational Site Number 6160074

Bydgoszcz, , 85-667

Investigational Site Number 6160073, Krakow, Poland

Status

Active, not recruiting

Address

Investigational Site Number 6160073

Krakow, , 31-503

Investigational Site Number 6160071, Lodz, Poland

Status

Completed

Address

Investigational Site Number 6160071

Lodz, , 91-738

Investigational Site Number 6160070, Lublin, Poland

Status

Completed

Address

Investigational Site Number 6160070

Lublin, , 20-093

Investigational Site Number 6160072, Sosnowiec, Poland

Status

Active, not recruiting

Address

Investigational Site Number 6160072

Sosnowiec, , 41-218

Investigational Site Number 6430001, Moscow, Russian Federation

Status

Recruiting

Address

Investigational Site Number 6430001

Moscow, , 115522

Investigational Site Number 6430062, Moscow, Russian Federation

Status

Recruiting

Address

Investigational Site Number 6430062

Moscow, , 117198

Investigational Site Number 6430063, Moscow, Russian Federation

Status

Recruiting

Address

Investigational Site Number 6430063

Moscow, , 119991

Investigational Site Number 7240050, Esplugues De Llobregat, Spain

Status

Recruiting

Address

Investigational Site Number 7240050

Esplugues De Llobregat, , 08950

Investigational Site Number 7240053, Madrid, Spain

Status

Recruiting

Address

Investigational Site Number 7240053

Madrid, , 28009

Investigational Site Number 7240052, Madrid, Spain

Status

Recruiting

Address

Investigational Site Number 7240052

Madrid, , 28046

Investigational Site Number 7240051, Valencia, Spain

Status

Recruiting

Address

Investigational Site Number 7240051

Valencia, , 46026

Investigational Site Number 8260033, Liverpool, United Kingdom

Status

Recruiting

Address

Investigational Site Number 8260033

Liverpool, , L12 2AP

Investigational Site Number 8260031, London, United Kingdom

Status

Recruiting

Address

Investigational Site Number 8260031

London, , WC1N 3JH