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

NCT ID: NCT02776735

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-06
• Study Completion Date: 2023-12-27

Brief Summary

Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in participants 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 participants with pcJIA.

Detailed Description

For 73 participants enrolled in the dose-finding and second portions, the total study duration per participant was up to 166 weeks that consists 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 29 participants enrolled in the third portion, the total study duration per participant was up to 106 weeks that consists of a 4- week screening, a 12-week core treatment phase, a 84-week extension phase, and a 6-week post-treatment follow-up.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarilumab

Participants received one of three ascending dose regimens of sarilumab by subcutaneous (SC) injection based on body weight. All the participants received the selected dose regimen once this was identified. Sarilumab was given during 12-week core treatment phase followed by an extension treatment phase (144 weeks for 73 participants enrolled in dose-finding and second portions and 84 weeks for approximately 29 participants enrolled in third portion)

Group Type: EXPERIMENTAL

Sarilumab

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

Interventions

Sarilumab

Pharmaceutical form:Solution Route of administration: Subcutaneous

Intervention Type: DRUG

Other Intervention Names

SAR153191 (REGN88)

Eligibility Criteria

Inclusion Criteria

• Male and female participants 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
• Participant 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 participants enrolled in the 3 ascending dose cohorts, then body weight <10 kg for participants 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).
• 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 participants.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Children's Hospital Los Angeles Site Number : 8400416

Los Angeles, California, United States

Investigational Site Number : 0320060

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320004

San Miguel de Tucumán, , Argentina

Investigational Site Number : 1240112

Montreal, Quebec, Canada

Investigational Site Number : 1520016

Concepción, Región del Biobío, Chile

Investigational Site Number : 2030041

Brno, , Czechia

Investigational Site Number : 2460040

Helsinki, , Finland

Investigational Site Number : 2500040

Paris, , France

Investigational Site Number : 2760064

Berlin, , Germany

Investigational Site Number : 2760061

Bremen, , Germany

Investigational Site Number : 2760062

Hamburg, , Germany

Investigational Site Number : 2760060

Sankt Augustin, , Germany

Investigational Site Number : 3800052

Roma, , Italy

Investigational Site Number : 4840061

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840060

Monterrey, Nuevo León, Mexico

Investigational Site Number : 5280020

Utrecht, , Netherlands

Investigational Site Number : 6160074

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6160073

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160070

Lublin, Lubusz Voivodeship, Poland

Investigational Site Number : 6160071

Lodz, Lódzkie, Poland

Investigational Site Number : 6160072

Sosnowiec, Silesian Voivodeship, Poland

Investigational Site Number : 6430001

Moscow, , Russia

Investigational Site Number : 6430062

Moscow, , Russia

Investigational Site Number : 6430063

Moscow, , Russia

Investigational Site Number : 7240050

Esplugues de Llobregat, Catalunya [Cataluña], Spain

Investigational Site Number : 7240052

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240053

Madrid, , Spain

Investigational Site Number : 7240051

Valencia, , Spain

Investigational Site Number : 8260031

London, London, City of, United Kingdom

Investigational Site Number : 8260033

Liverpool, , United Kingdom

Countries

United States; Argentina; Canada; Chile; Czechia; Finland; France; Germany; Italy; Mexico; Netherlands; Poland; Russia; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1177-3487

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-003999-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRI13925

Identifier Type: -

Identifier Source: org_study_id