An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2015-003999-79-Outside-EU/EEA
• Date of registration: 08/04/2016
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)
• Scientific title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase
• Target sample size: 36
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003999-79
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Argentina, Canada, Chile, Czech Republic, Estonia, Finland, France, Germany, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: -
• Affiliation: sanofi-aventis recherche & développement

• Name: -
• Affiliation: sanofi-aventis recherche & développement

Key inclusion & exclusion criteria

Inclusion criteria:
-Male and female patients aged =2 and =17 years at the time of the screening visit.
-Diagnosis of rheumatoid factor-negative or rheumatoid factor positive polyarticular Juvenile Idiopathic Arhtritis (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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-Body weight <10 kg or >60 kg.
-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 0.5 mg/kg/day (or 30 mg/day) within 2 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 DMARD 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
-Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
-Active tuberculosis patients or latent tuberculosis patients without adequate treatment.
-Exclusion criteria related to past or current infection other than tuberculosis.
-Any live, attenuated vaccine within 4 weeks prior to the baseline, such as varicella-zoster, oral polio, rubella vaccines.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Juvenile idiopathic arthritis
MedDRA version: 18.1 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Current Sponsor code: SAR153191 (REGN88)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-

Primary Outcome(s)

Primary end point(s): Assessment of PK parameter: maximum serum concentration observed (Cmax)
Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)

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

Main Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients with pcJIA in order to identify the dose and regimen for continued development in this population.

Timepoint(s) of evaluation of this end point: Up to week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-5: Up to week 12
6-8: Up to week 104

Secondary end point(s): 1- Number of patients with adverse events
2- Number of patients with local site reactions
3- Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) response rate
4- Change from baseline in individual JIA ACR components
5- Changes in IL-6 associated biomarkers
6- Number of patients with adverse events
7- Number of patients with local site reactions
8- Change from baseline in individual JIA ACR components

Secondary ID(s)

DRI13925

Source(s) of Monetary Support

sanofi-aventis recherche & développement