Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776735
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Sarilumab Phase 2

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 6, 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
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)
Drug: Sarilumab
Pharmaceutical form:Solution Route of administration: Subcutaneous
Other Name: SAR153191 (REGN88)




Primary Outcome Measures :
  1. Assessment of PK parameter: maximum serum concentration observed (Cmax) [ Time Frame: Up to Week 12 ]
  2. 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 ]
  3. Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough) [ Time Frame: Up to Week 12 ]

Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Core treatment phase: Up to Week(W) 12. Extension phase: Up to end of study (W162 for dose-finding and second portions or W102 for third portion) ]
  2. Number of patients with local site reactions [ Time Frame: Core treatment phase: Up to Week 12. Extension phase: Up to end of treatment (W156 for dose-finding and second portions or W96 for third portion) ]
  3. Juvenile Idiopathic Arthritis (JIA ACR) 30/50/70/90/100 response rate [ Time Frame: Core treatment phase: Up to Week 12. Extension phase: up to W156 for dose-finding and second portions or W96 for third portion ]
  4. 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: up to W156 for dose-finding and second portions or W96 for third portion ]
  5. 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: up to W156 for dose-finding and second portions or W96 for third portion ]
  6. 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: up to W156 for dose-finding and second portions or W96 for third portion ]
  7. Change from baseline in JIA ACR Component: Number of joints with active arthritis [ Time Frame: Core treatment phase: Up to Week 12. Extension phase: up to W156 for dose-finding and second portions or W96 for third portion ]
  8. 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: up to W156 for dose-finding and second portions or W96 for third portion ]
  9. 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: up to W156 for dose-finding and second portions or W96 for third portion ]
  10. Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS) [ Time Frame: Core treatment phase: Up to Week 12. Extension phase: up to W156 for dose-finding and second portions or W96 for third portion ]
  11. Change in IL-6 associated biomarkers: IL6 [ Time Frame: Up to Week 12 ]
  12. Change in IL-6 associated biomarkers: sIL-6R [ Time Frame: Up to Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776735


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02776735    
Other Study ID Numbers: DRI13925
2015-003999-79 ( EudraCT Number )
U1111-1177-3487 ( Other Identifier: UTN )
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases