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    Summary
    EudraCT Number:2014-000720-18
    Sponsor's Protocol Code Number:CNTO1959PSO3002
    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:2014-09-22
    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 number2014-000720-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis with Randomized Withdrawal and Retreatment
    Estudio multicéntrico de fase 3, aleatorizado, doble ciego, controlado con placebo y fármaco activo, para evaluar la eficacia y la seguridad de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave en los que se retira y reinicia el tratamiento de forma aleatoria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis with Randomized Withdrawal and Retreatment
    Un estudio de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave en los que se retira y reinicia el tratamiento de forma aleatoria
    A.3.2Name or abbreviated title of the trial where available
    VOYAGE 2
    VOYAGE 2
    A.4.1Sponsor's protocol code numberCNTO1959PSO3002
    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+3491722 81 00
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameHumira
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 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
    Soriasis en placa de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Soriasis
    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 evaluate the efficacy of guselkumab in the treatment of subjects with moderate to severe plaque-type psoriasis.
    ? To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis.
    Evaluar la eficacia de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave
    Evaluar la seguridad y tolerabilidad de guselkumab en pacientes con psoriasis en placa de moderada a grave
    E.2.2Secondary objectives of the trial
    ? To compare the efficacy of guselkumab to adalimumab in subjects with moderate to severe plaque-type psoriasis.
    ? To evaluate the maintenance of response to guselkumab in subjects continuing on a 100 mg q8w regimen compared with the maintenance of response in subjects who have active treatment withdrawn.
    ? To evaluate the effect of treatment with guselkumab on other measures of signs and symptoms of psoriasis.
    ? To evaluate the effect of treatment with guselkumab on health-related quality of life and health economic outcomes.
    Para comparar la eficacia de guselkumab a adalimumab en pacientes con psoriasis en placa de moderada a grave.
    Para evaluar el mantenimiendo de la respuesta a guselkumab en los pacientes que continúan con una pauta de 100 mg c8s en comparación con elmantenimiento de la respuesta en los pacietnes a los que se retira el tratamiento activo.
    Para evaluar el efecto del tratamiento con guselkumab en otras medidas de signos y síntomas de la psoriasis.
    Para evaluar el efecto del tratamiento con guselkumab en la calidad relacionada con la salud de los resultados económicos de vida y salud.
    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.
    Overview photographs of the whole body as well as photographs of selected psoriatic skin lesions will be taken at a subset of study sites in patients who provide an additional consent.
    Protocol A0, dated 10 July 2014
    Muestras de biopsia de piel se recogerán a partir de un subgrupo de sujetos que den su consentimiento para participar en el subestudio biopsia opcional. La inscripción en el estudio de la biopsia será opcional e incluirá aproximadamente 120 a 150 sujetos en los sitios de estudio seleccionados. Sólo los sujetos que den su consentimiento para participar en el subestudio biopsia opcional se someterán a la recolección de estas muestras. Las biopsias se utilizarán para la evaluación de la expresión génica y repertorio de células T. Las muestras de sangre se recogerán desde el subgrupo de sujetos que den su consentimiento para participar en el subestudio biopsia opcional. Células mononucleares de sangre periférica (PBMCs) se aislaron de estas muestras y se procesaron para análisis repertorio inmune con la evaluación de la clonalidad de células T del receptor.
    Resumen fotografías de todo el cuerpo, así como fotografías de las lesiones cutáneas psoriásicas seleccionados serán tomadas en un subconjunto de los sitios de estudio en los pacientes que prestan un consentimiento adicional.
    Protocolo A0, de fecha 10 de julio 2014
    E.3Principal inclusion criteria
    -Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
    - 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) score >=3 at Screening and at Baseline
    - Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
    - Must be a candidate for either systemic therapy or phototherapy for psoriasis
    Tener un diagnóstico de la psoriasis de placas (con o sin artritis psoriásica) por lo menos 6 meses antes de la primera administración del fármaco del estudio
    Tener un Psoriasis Area and Severity Index (PASI) mayor o igual que (> =) 12 en la selección y en la visita basal - Tener una (IGA) Resultado de Evaluación Global del Investigador> = 3 en la selección y en la línea de base
    - ¿Tienes una superficie corporal involucrada (BSA)> = 10 por ciento (%) en la selección y en la línea de base
    - Debe ser un candidato para cualquiera de las terapias sistémicas o fototerapia para la psoriasis
    E.4Principal exclusion criteria
    - Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
    - Participants who have ever received guselkumab or adalimumab
    - 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 any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
    - Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
    Candidatos que tengan un tipo de psoriasis que no sea en placa (p. ej., eritrodérmica, en gota o pustulosa) o con psoriasis inducida por fármacos actual (por ejemplo, una nueva aparición de la psoriasis o una exacerbación de la psoriasis de bloqueadores beta, antagonistas del calcio o litio)
    - Los participantes que han recibido alguna vez guselkumab o adalimumab
    - Historia o actuales signos o síntomas de severa, progresiva,Tengan o hayan tenido signos o síntomas de alteraciones graves, progresivas o no controladas de tipo renal, cardíaco, vascular, pulmonar, gastrointestinal, endocrino, neurológico, hematológico, reumatológico, psiquiátrico o metabólico.
    Presenten un trastorno que haga que, en opinión del investigador, la participación en el estudio no sea la mejor opción para el paciente (por ejemplo, por comprometer su bienestar) o que pueda impedir, limitar o confundir las evaluaciones descritas en el protocolo- Está embarazada, amamantando o planea un embarazo (tanto hombres como mujeres) dentro de los 5 meses después de la última administración del fármaco del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are the proportions of subjects who achieve an IGA score of cleared (0) or minimal (1) and the proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the placebo group.
    Los dos criterios de valoración principales son el porcentaje de pacientes que logran una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) y el porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 16, comparando el grupo de guselkumab y el grupo de placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    ? The proportion of subjects who achieve an IGA score of cleared at Week 24, comparing the guselkumab group and the adalimumab group.
    ? The proportion of subjects who achieve an IGA score of cleared or minimal at Week 24, comparing the guselkumab group and the adalimumab group.
    ? The proportion of subjects who achieve a PASI 90 response at Week 24, comparing the guselkumab group and the adalimumab group.
    ? The time to loss of PASI 90 response through Week 48, comparing subjects randomized to placebo and subjects randomized to continue guselkumab 100 mg q8w at Week 28.
    ? The change from baseline in DLQI score at Week 16, comparing the guselkumab group and the placebo group.
    ? The proportion of subjects who achieve an IGA score of cleared or minimal at Week 16, comparing the guselkumab group and the adalimumab group.
    ? The proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the adalimumab group.
    ? The proportion of subjects who achieve a PASI 75 response at Week 16, comparing the guselkumab group and the adalimumab group.
    ? The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and have at least a 2-grade improvement from baseline at Week 16, comparing the guselkumab group and the placebo group among randomized subjects with scalp psoriasis and an ss-IGA score ?2 at baseline.
    ? The change from baseline in PSSD symptom score at Week 16, comparing the guselkumab group and the placebo group.
    ? The proportion of subjects who achieve a PSSD symptom score=0 at Week 24, comparing the guselkumab group and adalimumab group among randomized subjects with a baseline PSSD symptom score ?1.


    Other Secondary Endpoints

    Placebo Comparisons

    ? The proportion of subjects who achieve an IGA score of cleared and the proportion of subjects achieving an IGA score of mild or better (?2) at Week 16.
    ? The proportion of subjects who achieve a PASI 100 response, PASI 75 response, and a PASI 50 response at Week 16.
    ? The percent improvement from baseline in PASI response through Week 16.
    ? The proportion of subjects who achieve a DLQI score=0 or 1 at Week 16 among randomized subjects with baseline DLQI>1.
    ? The proportion of subjects with a reduction of 5 or more points in DLQI score at Week 16.
    ? The percent improvement from baseline in NAPSI at Week 16 among randomized subjects with nail psoriasis at baseline.
    ? The proportion of subjects who achieve an f-PGA score of clear or minimal and have at last 1 grade improvement from baseline at Week 16 among randomized subjects with f PGA ?2 at baseline.
    ? The proportion of subjects who achieve a PSSD symptom score=0 at Week 16 among randomized subjects with a baseline PSSD symptom score ?1.
    ? The proportion of subjects who achieve a PSSD sign score=0 at Week 16 among randomized subjects with a baseline PSSD sign score ?1.
    ? The change from baseline in individual scale score of PSSD components at Week 16 among randomized subjects.
    ? The proportion of subjects who achieve PSSD individual scale score of 0 at Week 16 among randomized subjects with scale score ?1 at baseline.
    ? The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and a reduction of at least 2 grades on the hf-PGA scale from baseline at Week 16 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ?2 at baseline.
    ? Change from baseline in the physical and mental component summary scores of SF-36 at Week 16.
    ? The change from baseline in HADS at Week 16.
    ? The change from baseline in WLQ at Week 16.

    Guselkumab versus Adalimumab

    ? The proportion of subjects who achieve a PASI 75 response and a PASI 100 response at Week 24.
    ?The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with scalp psoriasis and an ss-IGA score ?2 at baseline.
    ? The percent improvement from baseline in NAPSI at Week 24 among randomized subjects with nail psoriasis at baseline.
    ? The proportion of subjects who achieve an f-PGA score of clear or minimal and have at least a 1-grade improvement from baseline at Week 24 among subjects with f-PGA ?2 at baseline.
    ? The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ?2 at baseline.
    ? The proportion of subjects who achieve a DLQI score=0 or 1 at Week 24 among randomized subjects with baseline DLQI>1.
    ? The change from baseline in the PSSD symptom score at Week 24.

    Please see protocol for other secondary endpoints
    Comparación del porcentaje de pacientes que logran una puntuación IGA de aclaramiento (0) en la semana 24 entre el grupo de guselkumab y el grupo de adalimumab.
    Comparación del porcentaje de pacientes que logran una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 24 entre el grupo de guselkumab y el grupo de adalimumab.
    Comparación del porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 24 entre el grupo de guselkumab y el grupo de adalimumab.
    Comparación del tiempo transcurrido hasta la desaparición de la respuesta PASI 90 hasta la semana 48 entre los pacientes aleatorizados para recibir placebo y los aleatorizados para continuar con guselkumab 100 mg c8s en la semana 28.
    Comparación de la variación de la puntuación DLQI entre el momento basal y la semana 16 entre el grupo de guselkumab y el grupo de placebo.
    Análisis de no inferioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que logran una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 16.
    Análisis de no inferioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 16.
    Análisis de no inferioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que obtienen una respuesta PASI 75 en la semana 16.
    Análisis de superioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que logran una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 16.
    Análisis de superioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que obtienen una respuesta PASI 90 en la semana 16.
    Análisis de superioridad del grupo de guselkumab respecto al grupo de adalimumab mediante el porcentaje de pacientes que obtienen una respuesta PASI 75 en la semana 16.
    Comparación del porcentaje de pacientes que logran una puntuación ss-IGA de ausencia de enfermedad (0) o enfermedad muy leve (1) y presentan una mejora de al menos 2 grados entre el momento basal y la semana 16 entre el grupo de guselkumab y el grupo de placebo en los pacientes aleatorizados con psoriasis del cuero cabelludo y una puntuación ss-IGA mayor o igual a 2 en el momento basal.
    Comparación de la variación de la puntuación PSSD de los síntomas entre el momento basal y la semana 16 entre el grupo de guselkumab y el grupo de placebo.
    Comparación del porcentaje de pacientes que obtienen una puntuación PSSD de los síntomas igual a 0 en la semana 24 entre el grupo de guselkumab y el grupo de adalimumab, en los pacientes aleatorizados con una puntuación PSSD de los síntomas mayor o igual a 1 en el momento basal.
    Por favor ver Protocolo para otros Análisis secundarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16/ Week 24/ Week 48
    Semana 16/ Semana 24/ Semana 48
    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 Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Czech Republic
    Germany
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    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 months8
    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 months8
    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: 900
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 1000
    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.
    No hay planes para un tratamiento adicional o atención después de los extremos sujetos (o ha terminado) la participación en el ensayo.
    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 Decision2014-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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