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    Summary
    EudraCT Number:2014-000721-20
    Sponsor's Protocol Code Number:CNTO1959PSO3003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-22
    Trial results View 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 number2014-000721-20
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
    Estudio multicéntrico de fase 3, aleatorizado y doble ciego para evaluar la eficacia y la seguridad de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave y una respuesta inadecuada a ustekinumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
    Estudio de Guselkumab en pacientes con con psoriasis en placa de moderada a grave y una respuesta inadecuada a ustekinumab
    A.3.2Name or abbreviated title of the trial where available
    NAVIGATE
    NAVIGATE
    A.4.1Sponsor's protocol code numberCNTO1959PSO3003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPº Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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 nameGuselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB130392
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Plaque Type Psoriasis
    Psoriasis en placa de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasis
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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 compare the efficacy of the following 2 treatment paradigms in subjects who have achieved an inadequate (Investigator?s Global Assessment [IGA] ?2) response to ustekinumab at Week 16:
    - Switching to guselkumab treatment.
    - Remaining on ustekinumab treatment.
    ? To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis and an inadequate (IGA?2) response to ustekinumab at Week 16.
    Comparar la eficacia de los 2 paradigmas de tratamiento siguientes en pacientes que hayan obtenido una respuesta inadecuada (Investigator´s Global Assessment [IGA] ?2) a ustekinumab en la semana 16:
    Cambio a un tratamiento con guselkumab.
    Continuación del tratamiento con ustekinumab.
    Evaluar la seguridad y tolerabilidad de guselkumab en pacientes con psoriasis en placa de moderada a grave y una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16
    E.2.2Secondary objectives of the trial
    ? To evaluate the effect of switching to guselkumab on patient-reported signs and symptoms of psoriasis for subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
    ? To assess the PK and immunogenicity of guselkumab after subcutaneous (SC) administrations in subjects with moderate to severe plaque-type psoriasis and an inadequate (IGA?2) response to ustekinumab at Week 16.
    Evaluar el efecto del cambio a guselkumab en los signos y síntomas comunicados por el propio paciente en pacientes con una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16.
    Evaluar la Farmacocinética (FC o PK) y la inmunogenicidad de guselkumab después de administraciones subcutáneas (SC) en pacientes con psoriasis en placa de moderada a severa y una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Skin biopsy samples will be collected from a subset of subjects who consent to participate in the optional biopsy substudy. Enrollment in the biopsy study will be optional and will include approximately 120 to 150 subjects at selected study sites. Only subjects who consent to participate in the optional biopsy substudy will undergo collection of these samples. Biopsies will be used for assessment of gene expression and T cell repertoire.
    Whole blood samples will be collected from the subset of subjects who consent to participate in the optional biopsy substudy. Peripheral blood mononuclear cells (PBMCs) will be isolated from these samples and processed for immune repertoire analysis with assessment of T-cell receptor clonality.
    Protocol version A0, dated 03 July 2014
    Se recogerán muestras de biopsias cutáneas de un subgrupo de pacientes que otorguen su consentimiento para participar en el subestudio opcional de biopsias. La participación en el estudio de biopsias será opcional y se reclutará a 120 pacientes en una serie de centros predefinidos. Únicamente se recogerán estas muestras en los pacientes que otorguen su consentimiento para participar en el estudio opcional de biopsias. Las biopsias se utilizarán para evaluar la expresión del RNA y para analizar las poblaciones de células inmunitarias con evaluación de la clonalidad de los receptores de linfocitos T.
    Se recogerán muestras de sangre total de un subgrupo de pacientes que otorguen su consentimiento para participar en el subestudio opcional de biopsias. Se aislarán células mononucleares de sangre periférica (CMSP) a partir de esas muestras y se procesarán para el análisis de poblaciones de células inmunitarias con evaluación de la clonalidad de los receptores de linfocitos T.
    Protocolo, 3 de julio de 2014
    E.3Principal inclusion criteria
    - Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
    - Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
    - Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
    - Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
    - Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
    Tener un diagnóstico de psoriasis en placa (con o sin artritis psoriásica) desde por lo menos 6 meses antes de la administración de la primera dosis de la medicación del estudio.
    Tener un PASI ?12 en la selección (screening) y en la visita basal.
    Tener una IGA ?3 en la selección (screening) y en la visita basal.
    Tener un ASC afectada ?10% en la selección (screening) y en la visita basal.
    Ser candidatos a fototerapia o a tratamiento sistémico para la psoriasis (tanto si tiene como si no tiene antecedentes de tratamiento previo).
    E.4Principal exclusion criteria
    - Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
    - Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
    - Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
    - Has previously received guselkumab or ustekinumab
    Tengan signos o síntomas de alteraciones graves, progresivas o no controladas de tipo renal, hepático, cardíaco, vascular, pulmonar, gastrointestinal, endocrino, neurológico, hematológico, reumatológico, psiquiátrico o metabólico.
    Tengan una enfermedad cardiovascular inestable, definida como un deterioro clínico reciente (p. ej., angina inestable, fibrilación atrial rápida) en los últimos 3 meses o una hospitalización por motivos cardíacos en los últimos 3 meses.
    Tengan actualmente una neoplasia maligna o tengan antecedentes de la misma en los 5 años anteriores a la selección (screening) (con la excepción de un cáncer de piel no melanocítico que haya sido debidamente tratado sin signos de recidiva desde por lo menos 3 meses antes de la administración de la primera dosis de la medicación del estudio, o un carcinoma cervical in situ que haya sido tratado sin signos de recidiva desde por lo menos 3 meses antes de la administración de la primera dosis de la medicación del estudio).
    Hayan recibido tratamiento previo con guselkumab o ustekinumab.
    E.5 End points
    E.5.1Primary end point(s)
    ? The number of visits at which subjects achieve an IGA response of cleared (0) or minimal (1) and at least a 2 grade improvement (from Week 16) from Week 28 through Week 40, among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
    Número de visitas en las que se obtiene una respuesta IGA de aclaramiento (0) o enfermedad mínima (1) y una mejora de al menos 2 grados (respecto a la semana 16) entre la semana 28 y la semana 40, en los pacientes aleatorizados con una respuesta (IGA?2) inadecuada a ustekinumab en la semana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28 / Week 32/week 36/ week 40
    Semana 28 / Semana 32 / Semana 36/ Semana 40
    E.5.2Secondary end point(s)
    Major Secondary Endpoints
    ? The number of visits at which subjects achieve a PASI 90 response from Week 28 through Week 40 among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
    ? The number of visits at which subjects achieve an IGA response of cleared (0) from Week 28 through Week 40 among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
    ? The proportion of subjects who achieve an IGA of 0 or 1 and at least a 2-grade improvement (from Week 16) at Week 28.

    Other Secondary Endpoints
    Subjects with an inadequate (IGA?2) response to ustekinumab at Week 16
    ? The number of visits at which subjects achieve a PASI 100 response from Week 28 through Week 40.
    ? The number of visits at which subjects achieve a PASI 75 response from Week 28 through Week 40.
    ? The average percent improvement from baseline in PASI response between Week 28 and Week 40.
    ? The number of visits at which subjects achieve a DLQI of 0 or 1 from Week 28 through Week 40 among randomized subjects with DLQI >1 at Week 16.
    ? The number of visits at which subjects achieve a PSSD symptom score of 0 from Week 28 through Week 40 among randomized subjects with a PSSD symptom score ?1 at Week 16.
    ? The number of visits at which subjects achieve a PSSD sign score of 0 from Week 28 through Week 40 among randomized subjects with a PSSD sign score ?1 at Week 16.
    ? The number of visits at which subjects achieve a score of 0 for each PSSD individual scale from Week 28 through Week 40 among randomized subjects with PSSD scale score ?1 at Week 16.
    ? The proportion of subjects who achieve a PASI 90 response at Week 28.
    ? The proportion of subjects who achieve an IGA of 0 or 1 and at least a 2-grade improvement (from Week 16) at Week 52.
    ? The proportion of subjects who achieve a PASI 90 response at Week 52.
    ? The proportion of subjects who achieve a PSSD symptom score of 0 at Week 52 among randomized subjects with a PSSD symptom score ?1 at Week 16.
    ? The proportion of subjects who achieve a PSSD sign score of 0 at Week 52 among randomized subjects with a PSSD sign score ?1 at Week 16.
    ? The proportion of subjects who achieve DLQI of 0 and 1 at Week 52 among randomized subjects with DLQI >1 at Week 16.
    ? The proportion of subjects who achieve each PSSD individual score of 0 at Week 52 among randomized subjects with PSSD scale score ?1 at Week 16.
    Número de visitas en las que se obtiene una respuesta PASI 90 entre la semana 28 y la semana 40 en los pacientes aleatorizados con una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16.
    Número de visitas en las que se obtiene una respuesta IGA de aclaramiento (0) entre la semana 28 y la semana 40 en los pacientes aleatorizados con una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16.
    Porcentaje de pacientes que obtienen una IGA de 0 ó 1 y una mejora de al menos 2 grados (respecto a la semana 16) en la semana 28.
    Otros criterios de valoración secundarios:
    Pacientes con una respuesta inadecuada (IGA?2) a ustekinumab en la semana 16:
    Número de visitas en las que se obtiene una respuesta PASI 100 entre la semana 28 y la semana 40.
    Número de visitas en las que se obtiene una respuesta PASI 75 entre la semana 28 y la semana 40.
    Porcentaje medio de mejora de la respuesta PASI respecto a la puntuación basal entre la semana 28 y la semana 40.
    Número de visitas en las que se obtiene una DLQI de 0 ó 1 entre la semana 28 y la semana 40 en los pacientes aleatorizados con un DLQI >1 en la semana 16.
    Número de visitas en las que se obtiene una puntuación de los síntomas PSSD de 0 entre la semana 28 y la semana 40 en los pacientes aleatorizados con una puntuación de los síntomas PSSD ?1 en la semana 16.
    Número de visitas en las que se obtiene una puntuación de los signos PSSD de 0 entre la semana 28 y la semana 40 en los pacientes aleatorizados con una puntuación de los signos PSSD ?1 en la semana 16.
    Número de visitas en las que se obtiene una puntuación de 0 para cada una de las escalas individuales de PSSD entre la semana 28 y la semana 40 en los pacientes aleatorizados con una puntuación en la escala PSSD ?1 en la semana 16.
    Porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 28.
    Porcentaje de pacientes que obtienen una IGA de 0 ó 1 y una mejora de al menos 2 grados (respecto a la semana 16) en la semana 52.
    Porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 52.
    Porcentaje de pacientes que obtienen una puntuación de los síntomas PSSD de 0 en la semana 52 entre los pacientes aleatorizados con una puntuación de los síntomas PSSD ?1 en la semana 16.
    Porcentaje de pacientes que obtienen una puntuación de los signos PSSD de 0 en la semana 52 entre los pacientes aleatorizados con una puntuación de los signos PSSD ?1 en la semana 16.
    Porcentaje de pacientes que obtienen una DLQI de 0 y 1 en la semana 52 entre los pacientes aleatorizados con una DLQI >1 en la semana 16.
    Porcentaje de pacientes que obtienen una puntuación individual de cada PSSD de 0 en la semana 52 entre los pacientes aleatorizados con una puntuación en la escala PSSD ?1 en la semana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 28 / Week 32/week 36/ week 40 / Week 52
    Semana 28 / Semana 32/ Semana 36/ Semana 40/ Semana 52
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Canada
    Germany
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    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
    Ultima 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 months1
    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 months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 800
    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)
    There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.
    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 Decision2014-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-24
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