Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-004000-35
    Sponsor's Protocol Code Number:DRI13926
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-004000-35
    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 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase
    Estudio abierto, secuencial, de búsqueda de dosis ascendentes y repetidas de sarilumab administrado con inyección subcutánea (s. c.) a niños y adolescentes con edades comprendidas entre 1 y 17 años con artritis idiopática juvenil sistémica (AIJS), seguido de una fase de extensión
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
    Estudio de búsqueda de dosis repetidas de sarilumab a niños y adolescentes con artritis idiopática juvenil sistémica (AIJS)
    A.4.1Sponsor's protocol code numberDRI13926
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1177-3584
    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, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number934859400
    B.5.6E-mailES-unidadestudiosclinicos@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
    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
    Artritis idiopática juvenil
    E.1.1.1Medical condition in easily understood language
    Juvenile Idiopathic Arthritis
    Artritis idiopática juvenil
    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 19.0
    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 with sJIA in order to identify the dose and regimen for continued development in this population.
    Describir el perfil farmacocinético (FC) de sarilumab en pacientes con edades comprendidas entre 1 y 17 años con AIJS para identificar la dosis y la pauta para el desarrollo continuo en esta población
    E.2.2Secondary objectives of the trial
    To describe:
    -The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients with sJIA.
    -The long term safety of sarilumab in patients with sJIA.
    Describir:
    • El perfil farmacodinámico (FD), la eficacia y la seguridad de sarilumab en pacientes con AIJS
    • La seguridad a largo plazo de sarilumab en pacientes con AIJS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female patients aged ≥1 and ≤17 years at the time of the screening visit.
    -Diagnosis of systemic Juvenile Idiopathic Arthritis (JIA) subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with the following features at screening:
    -≥5 active joints at screening or;
    -≥2 active joints at screening with systemic JIA fever >37.5 °C in the 3 days preceding baseline or for at least 3 out of any 7 consecutive days during screening despite glucocorticoids at a stable dose for at least 3 days.
    -Patients 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.
    Pacientes de ambos sexos con edades comprendidas entre más o igual a 1 y inferior o igual a17 años en el momento de la visita de selección
    Diagnóstico del subtipo de AIJ sistémica según los Criterios de Clasificación de la Artritis Idiopática Juvenil de 2001 de la Liga Internacional de Asociaciones de Reumatología (International League of Rheumatology Associations, ILAR) (1) con las características siguientes:
    - Más o igual a 5 articulaciones activas en la selección o
    - Más o igual a 2 articulaciones activas en la selección con fiebre por AIJ sistémica >37,5 0C en los 3 días previos al momento basal o durante al menos 3 de 7 días consecutivos cualesquiera durante la selección, a pesar de recibir glucocorticoides a una dosis estable durante al menos 3 días
    Pacientes que respondan de forma inadecuada al tratamiento actual y se les considere candidatos a un FARME biológico según el criterio del investigador
    El paciente (que haya alcanzado la edad legal de consentimiento según la reglamentación local) o el/los progenitor(es) o tutor(es) legal(es) firmarán y fecharán el consentimiento informado por escrito aprobado por el Comité Ético (CE). El asentimiento del paciente debe obtenerse con arreglo a la reglamentación local, a la madurez del paciente y a su capacidad intelectual para comprender la información asociada al estudio
    E.4Principal exclusion criteria
    -Body weight <10 kg or >60 kg.
    -Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome within 6 months prior to screening.
    -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.
    -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 adquate 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.
    • Peso corporal <10 kg o >60 kg
    • Síntomas sistémicos graves no controlados o síndrome de activación macrofágica durante los 6 meses previos a la selección
    • Si se toman antiinflamatorios no esteroideos (AINE) (incluidos los inhibidores de la ciclooxigenasa 2 [COX-2]), mantenimiento de una dosis estable durante menos de 2 semanas antes de la visita basal, o pauta prescrita para una indicación no autorizada
    • Si está tomando un FARME no biológico, mantenimiento de una dosis estable durante menos de 6 semanas antes de la visita basal o a una dosis superior a la recomendada por la ficha técnica local
    • Si se toman glucocorticoides orales, una dosis superior al equivalente a 1 mg/kg/día (o 60 mg/día) de prednisona durante los 3 días anteriores al momento basal
    • Inyección de glucocorticoides intraarticulares en las 4 semanas previas al momento basal.
    • Tratamiento previo con anti-interleucina-6 (IL-6 [sic: anti-IL-6]) o con antagonistas del receptor de IL-6 (IL-6R), incluidos, entre otros, tocilizumab o sarilumab
    • Tratamiento con cualquier FARME biológico dentro de las 5 vidas medias anteriores a la primera dosis de sarilumab del modo siguiente (los procedimientos y periodos de descanso del tratamiento necesarios pueden variar en función de los requisitos locales):
    Etanercept: en las 4 semanas anteriores (vida media: 3-5,5 días)
    Infliximab: en las 8 semanas anteriores (vida media: 7,5-9,5 días)
    Adalimumab: en las 15 semanas anteriores (vida media: 10-20 días)
    Anakinra: en los 2 días anteriores (vida media: 4-6 horas)
    Canakinumab: en las 19 semanas anteriores (vida media: 23-26 días)
    Abatacept: en las 10 semanas anteriores (vida media: 13-14 días)
    Rituximab u otro citorreductor: en las 16 semanas anteriores o hasta que el recuento total de linfocitos y el recuento de linfocitos CD 19+ se normalice, lo que suponga más tiempo (vida media: 19-22 días)
    Inmunoglobulina intravenosa (IGIV): en las 15 semanas anteriores (vida media: 21 días para la IgG)
    • Tratamiento con algún inhibidor de las cinasas Jano dentro de las 4 semanas anteriores a la primera dosis de sarilumab; y tratamiento con hormona del crecimiento en las 4 semanas anteriores a la primera dosis de sarilumab (los procedimientos y periodos de descanso del tratamiento necesarios pueden variar en función de los requisitos locales)
    • Tratamiento con cualquier producto en investigación biológico o no en las 8 semanas o 5 vidas medias anteriores al momento basal, lo que suponga más tiempo
    • Exclusión relacionada con tuberculosis (según lo descrito en ‎E 13)
    • Criterios de exclusión relacionados con una infección pasada o en curso distinta de la tuberculosis (según lo descrito en ‎E 14)
    • Alguna vacuna con virus vivos atenuados en las 4 semanas anteriores al momento basal, como por ejemplo, vacunas contra la varicela-zóster, la polio oral o la rubéola.
    • Alguna de las siguientes anomalías analíticas en la visita de selección (identificadas por el laboratorio central):
    Hemoglobina <7 g/dl
    Leucocitos <3000/mm3
    Neutrófilos <2000/mm3
    Recuento plaquetario <150 000 cél/mm3
    Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) >1,5 veces el límite superior de la normalidad (LSN)
    Bilirrubina (total) >LSN, a menos que al paciente se le haya diagnosticado la enfermedad de Gilbert mediante pruebas genéticas y esté documentado
    Presencia de hipercolesterolemia grave no controlada (>350 mg/dl, 9,1 mmol/l) o hipertrigliceridemia (>500 mg/dl, 5,6 mmol/l)
    Tasa de filtración glomerular estimada <30 ml/min/1,73 m2 según la fórmula de Schwartz modificada
    • Cardiopatía grave por AIJS
    • Pacientes adolescentes embarazadas o en periodo de lactancia
    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)
    - Evaluación de los parámetros PK: concentración sérica máxima observada (Cmax)
    - Evaluación de los parámetros PK: El área bajo la concentración sérica frente al tiempo calculado utilizando el método trapezoidal durante un intervalo de dosis (AUC 0-t)
    - Evaluación de los parámetros PK: Concentración observada antes de la administración del tratamiento durante la dosificación repetida (Cvalle)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to week 12
    A las 12 semanas
    E.5.2Secondary 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
    1- Número de pacientes con Acontecimientos adversos
    2- Número de pacientes con reacciones locales
    3- Tasa de respuesta ACR30 en AIJ artritis idiopática juvenil (AIJ) del American College of Rheumatology 30
    4- Cambio desde el momento basal en los componentes individuales del ACR en AIJ
    5- Cambios en los biomarcadores asociados a la IL-6
    6- Número de pacientes con Acontecimientos adversos
    7- Número de pacientes con reacciones locales
    8- Cambio desde el momento basal en los componentes individuales del ACR en AIJ
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5: Up to week 12
    6-8: Up to week 104
    1-5: a la semana 12
    6-8: a la semana 104
    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 No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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
    Brazil
    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
    última visita del último paciente
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 36
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    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 younger then legal age of consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 36
    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)
    None
    Ninguno
    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 Decision2016-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 01:10:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA