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    Summary
    EudraCT Number:2014-000719-15
    Sponsor's Protocol Code Number:CNTO1959PSO3001
    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 number2014-000719-15
    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
    Estudio multicéntrico de fase 3, aleatorizado y doble ciego, controlado con placebo y fármaco comparador activo, para evaluar la eficacia y la seguridad de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave
    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
    Un estudio de guselkumab en el tratamiento de pacientes con psoriasis en placa de moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    VOYAGE 1
    VOYAGE 1
    A.4.1Sponsor's protocol code numberCNTO1959PSO3001
    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 AddressPaseo de las 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 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
    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 evaluate the efficacy of guselkumab for 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 la 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 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.
    - Comparar la eficacia de guselkumab y adalimumab en pacientes con psoriasis en placa de moderada a grave.
    - Evaluar el efecto del tratamiento con guselkumab en otras medidas de los signos y síntomas de la psoriasis.
    - Evaluar el efecto del tratamiento con guselkumab en la calidad de vida relacionada con la salud y en los resultados de economía sanitaria.
    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 substudy will be optional and will include approximately 90 subjects at selected 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 RNA expression.
    Protocol A0, dated 10 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 subestudio de biopsias será opcional e incluirá a unos 90 pacientes en una serie de centros predefinidos. Únicamente se recogerán estas muestras en los pacientes que otorguen su consentimiento para participar en el subestudio opcional de biopsias. Las biopsias se utilizarán para evaluar la expresión de RNA.
    protocolo A0 de fecha 10 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 psoriasis en placa (con o sin APs) desde por lo menos 6 meses antes de la administración de la primera dosis de la medicación del estudio.
    - Tener un PASI(Psoriasis Area and Severity Index) >= 12 en la selección y en la visita basal.
    - Tener una IGA >= 3 en la selección y en la visita basal.
    - Tener una ASC afectada >= 10% en la selección y en la visita basal.
    - Ser candidatos a fototerapia o a tratamiento sistémico 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 wellbeing) 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
    -Tengan un tipo de psoriasis que no sea en placa (p. ej., eritrodérmica, en gota o pustulosa) o bien que tengan actualmente psoriasis medicamentosa (p. ej., aparición reciente o exacerbación de la psoriasis debida a la administración de betabloqueantes, antagonistas del calcio o litio).
    - Hayan recibido tratamiento previo con guselkumab o adalimumab.
    - 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.
    -Estén embarazadas, amamantando o planificando un embarazo (tanto los varones como las mujeres) en los 5 meses siguientes a la administración de la última dosis 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 criterios de valoración principales son el porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) y el porcentaje de pacientes que obtengan 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)
    Major Secondary Endpoints
    - The proportion of subjects who achieve an IGA score of cleared (0) at Week 24, comparing the guselkumab group and the adalimumab group.
    - The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) 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.
    -Theproportion of subjects who achieve an IGA score of cleared (0) at Week 48, comparing the guselkumab group and the adalimumab group.
    -The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) at Week 48, comparing the guselkumab group and the adalimumab group.
    -The proportion of subjects who achieve a PASI 90 response at Week 48, comparing the guselkumab group and the adalimumab group.
    -The change from baseline in DLQI score at Week 16, comparing the guselkumab group and placebo group.
    -The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) 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 (0) or very mild disease (1) and have at least a 2-grade improvement from baseline at Week 16, comparing the guselkumab group and 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 placebo group.
    - The proportion of subjects who achieve a PSSD symptom score=0 at Week 24, comparing the guselkumab group and the adalimumab group among randomized subjects with a baseline PSSD symptom score >= 1.
    Other Secondary Endpoints
    Placebo Comparisons (Guselkumab vs Placebo and Adalimumab vs Placebo)
    -The proportion of subjects who achieve an IGA score of cleared (0) and the proportion of subjects achieving an IGA score of mild or better ( <= 2) at Week 16.
    -The proportion of subjects who achieve PASI 100, PASI 75, and PASI 50 responses 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 the 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 (0) or minimal (1) and have at least a 1 grade improvement from baseline at Week 16 among randomized subjects with an f PGA score >=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.
    - 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.
    Guselkumab vs Adalimumab
    - The proportion of subjects who achieve a PASI 75 response and a PASI 100 response at Week 24 and Week 48.
    - The proportion of subjects who achieve an ss-IGA score of absence of disease (0) or very mild disease (1) and have at least a 2-grade improvement from baseline at Week 24 and Week 48 among randomized subjects with scalp psoriasis and an ss-IGA score >= 2 at baseline.
    - The percent improvement from baseline in NAPSI at Week 24 and Week 48 among randomized subjects with nail psoriasis at baseline.
    -The proportion of subjects who achieve an f-PGA score of clear (0) or minimal (1) and have at least 1-grade improvement from baseline at Week 24 and Week 48 among randomized subjects with an f PGA score >= 2 at baseline.
    -The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and have at least a 2-grade improvement from baseline at Week 24 and Week 48 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score greater than or equal to2 at baseline.
    -The proportion of subjects who achieve a DLQI score=0 or 1 at Week 24 and Week 48 among randomized subjects with baseline DLQI >1.
    See protocol for other secondary endpoints
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) en la semana 24, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 24, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una respuesta PASI 90 en la semana 24, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) en la semana 48, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 48, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una respuesta PASI 90 en la semana 48, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Variación de la puntuación DLQI entre el momento basal y la semana 16, comparando el grupo de guselkumab y el grupo de placebo.
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) o enfermedad mínima (1) en la semana 16, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una respuesta PASI 90 en la semana 16, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una respuesta PASI 75 en la semana 16, comparando el grupo de guselkumab y el grupo de adalimumab.
    -Porcentaje de pacientes que obtengan una puntuación ss-IGA de ausencia de enfermedad (0) o enfermedad muy leve (1) y que presenten una mejora de al menos 2 grados entre el momento basal y la semana 16, comparando el grupo de guselkumab y el grupo de placebo,entre los pacientes aleatorizados con psoriasis del cuero cabelludo y con una puntuación ss-IGA >=2 en el momento basal.
    -Variación de la puntuación de los síntomas PSSD entre el momento basal y la semana 16, comparando el grupo de guselkumab y el grupo de placebo.
    -Porcentaje de pacientes que obtengan una puntuación de los síntomas PSSD igual a 0 en la semana 24, comparando el grupo de guselkumab y el grupo de adalimumab, entre los pacientes aleatorizados con una puntuación de los síntomas PSSD >= 1 en el momento basal.
    Otros criterios de valoración secundarios
    Comparaciones con placebo (guselkumab frente a placebo y adalimumab frente a placebo)
    -Porcentaje de pacientes que obtengan una puntuación IGA de aclaramiento (0) y porcentaje de pacientes que obtengan una puntuación IGA de enfermedad leve o mejor (<=2) en la semana 16.
    -Porcentaje de pacientes que obtengan respuestas PASI 100, PASI 75 y PASI 50 en la semana 16.
    -Porcentaje de mejora de la respuesta PASI desde el momento basal hasta la semana 16.
    -Porcentaje de pacientes que obtengan una puntuación del DLQI de 0 ó 1 en la semana 16 entre los pacientes aleatorizados con una puntuación del DLQI >1 en el momento basal.
    -Porcentaje de pacientes con una reducción igual o superior a 5 puntos en el resultado del DLQI en la semana 16.
    -Porcentaje de mejora en la NAPSI entre el momento basal y la semana 16 entre los pacientes aleatorizados con psoriasis ungueal en el momento basal.
    -Porcentaje de pacientes que obtengan una puntuación de la f-PGA de aclaramiento (0) o enfermedad mínima (1) y que obtienen una mejora de al menos 1 grado en la semana 16 con respecto al momento basal, entre los pacientes aleatorizados con una puntuación de la f-PGA >=2 en el momento basal.
    -Porcentaje de pacientes que obtengan una puntuación de los síntomas PSSD de 0 en la semana 16 entre los pacientes aleatorizados con una puntuación de los síntomas PSSD >=1 en el momento basal.
    -Porcentaje de pacientes que obtienen una puntuación de los signos PSSD de 0 en la semana 16 entre los pacientes aleatorizados con una puntuación de los signos PSSD >=1 en el momento basal.
    -Variación de la puntuación en cada escala de los componentes del PSSD entre el momento basal y la semana 16.
    -Porcentaje de pacientes que obtengan una puntuación individual de cada escala del PSSD de 0 en la semana 16 entre los pacientes aleatorizados que tenían una puntuación ?1 en el momento basal.
    -Porcentaje de pacientes que obtengan una puntuación de la hf-PGA de aclaramiento (0) o casi remisión (1) y una reducción de al menos 2 grados en la escala hf-PGA entre el momento basal y la semana 16, entre los pacientes aleatorizados con psoriasis palmar o plantar y una puntuación en la hf-PGA >=2 en el momento basal
    Guselkumab frente a adalimumab
    Ver protocolo para otros criterios de valoración
    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 EEA45
    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
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    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 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: 675
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 300
    F.4.2.2In the whole clinical trial 750
    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 cuidados despues de que el sujeto termine (o haya 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 Opinion2014-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-17
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