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    Summary
    EudraCT Number:2015-003999-79
    Sponsor's Protocol Code Number:DRI13925
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2015-003999-79
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA)
    A.3.2Name or abbreviated title of the trial where available
    SKYPP
    A.4.1Sponsor's protocol code numberDRI13925
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1177-3487
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/067/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSarilumab
    D.3.2Product code SAR153191 (REGN88)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARILUMAB
    D.3.9.2Current sponsor codeSAR153191 (REGN88)
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile idiopathic arthritis
    E.1.1.1Medical condition in easily understood language
    Juvenile idiopathic arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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 continued
    development in this population.
    E.2.2Secondary objectives of the trial
    To describe the pharmacodynamics (PD) profile, the efficacy and the
    long term safety of sarilumab in patients with pcJIA.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 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.
    E.4Principal 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 cyclooxygenase-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.
    -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 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; 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, 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.
    E.5 End points
    E.5.1Primary 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to week 12
    E.5.2Secondary end point(s)
    1- Number of adverse events
    2- Acceptability assessments (local tolerability)
    3- Juvenile Idiopathic Arthritis (JIA ACR) 30/50/70/90/100 response
    rate
    4- Change from baseline in JIA ACR Component: Physician's global
    assessment of disease activity
    5- Change from baseline in JIA ACR Component: Patient / parent
    assessment of overall well-being
    6- Change from baseline in JIA ACR Component: Childhood Health
    Assessment Questionnaire (CHAQ) – Disability Index
    7- Change from baseline in JIA ACR Component: Number of joints with
    active arthritis
    8- Change from baseline in JIA ACR Component: Number of joints with
    limitation of motion
    9- Change from baseline in JIA ACR Component: High sensitivity Creactive protein (hs-CRP)
    10- Juvenile Arthritis Disease Activity Score-27 (JADAS) change from
    baseline
    11- Changes in IL-6 associated biomarkers
    12- Changes in IL-6 associated biomarkers : sIL-6 R
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Core treatment phase: Up to Week 12 - Extension phase: Up to end of study (W162 for dose-finding and second portions or W102 for third portion)
    2. 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 - 10. Core treatment phase: Core treatment phase: Up to Week 12 -Extension phase: up to W156 for dose-finding and second portions or W96 for third portion
    11 – 12. Up to Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Chile
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Italy
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 62
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric population aged ≥ 2 and ≤17 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 72
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After participation in the trial, patients will be treated with the current
    standard therapy in their country, under supervision of their medical
    practitioner.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-27
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