Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 February 2024 |
Main ID: |
NCT02991469 |
Date of registration:
|
14/10/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
|
Scientific title:
|
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 |
Date of first enrolment:
|
August 9, 2018 |
Target sample size:
|
72 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02991469 |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
Argentina
|
Bulgaria
|
Canada
|
Chile
|
Czechia
|
Estonia
|
Finland
|
France
|
Germany
|
Ireland
|
Italy
|
Netherlands
|
Poland
|
Russian Federation
|
Spain
|
United Kingdom
|
United States
| | | | | | | |
Contacts
|
Name:
|
For site information, send an email with site number to |
Address:
|
|
Telephone:
|
|
Email:
|
Contact-Us@sanofi.com |
Affiliation:
|
|
|
Name:
|
Clinical Sciences & Operations |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Sanofi |
| |
Key inclusion & exclusion criteria
|
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:
- 5 active joints at screening or
- 2 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.
Age minimum:
1 Year
Age maximum:
17 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Juvenile Idiopathic Arthritis
|
Intervention(s)
|
Drug: Sarilumab SAR153191 (REGN88)
|
Primary Outcome(s)
|
Assessment of PK parameter: maximum serum concentration observed (Cmax)
[Time Frame: Up to Week 12]
|
Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
[Time Frame: Up to Week 12]
|
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
[Time Frame: Up to Week 12]
|
Secondary Outcome(s)
|
Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in JIA ACR Component: Number of joints with active arthritis
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in JIA ACR component: Physician's global assessment of disease activity
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Number of patients with local site reactions
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156]
|
Change from baseline in JIA ACR Component: Number of joints with limitation of motion
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in JIA ACR Component: fever
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS)
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Changes in IL-6 associated biomarkers: sIL-6R
[Time Frame: Up to Week 12]
|
Proportion of patients free of glucocorticoids and without JIA flare
[Time Frame: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Changes in glucocorticoid use
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156]
|
Changes in IL-6 associated biomarkers: IL6
[Time Frame: Up to Week 12]
|
Number of patients with adverse events
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162]
|
Proportion of patients receiving glucocorticoids by dose category (glucocorticoid equivalent prednisone dose =0.5 mg/kg, =0.2 mg/kg and <0.5 mg/kg, <0.2 mg/kg)
[Time Frame: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate
[Time Frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156]
|
Secondary ID(s)
|
2015-004000-35
|
DRI13926
|
U1111-1177-3584
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|