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    Summary
    EudraCT Number:2014-005663-32
    Sponsor's Protocol Code Number:CAIN457A2310
    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:2015-07-31
    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 number2014-005663-32
    A.3Full title of the trial
    A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis
    Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo y fármaco activo para demostrar la eficacia de secukinumab subcutáneo en comparación con placebo y etanercept (en un brazo simple ciego) después de doce semanas de tratamiento y evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis en placas crónica grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of secukinumab in pediatric patients with severe plaque psoriasis.
    Estudio de la eficacia y la seguridad de secukinumab en pacientes pediátricos con psoriasis en placas grave.
    A.4.1Sponsor's protocol code numberCAIN457A2310
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/011/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A
    B.5.2Functional name of contact pointDepartamento Médico
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 namesecukinumab 150/1ml
    D.3.2Product code AIN457
    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 INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 namesecukinumab 75mg /0,5 ml
    D.3.2Product code AIN457
    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 INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.IMP: 3
    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 Embrel 25 mg polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa 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.3.4Pharmaceutical form Powder for 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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    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
    Plaque Psoriasis
    Psoriasis en placas
    E.1.1.1Medical condition in easily understood language
    Psoriasis looks like red, raised, scaly areas of the skin
    La psoriasis son como areas rojas, engrosadas y con escamas en la piel
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to non-biologic systemic therapies.
    El propósito de este estudio es demostrar la eficacia superior de secukinumab frente a placebo en la semana 12 basándose en las tasas de respuesta de PASI 75 e IGA mod. 2011 0 o 1 en niños y adolescentes de 6 a < 18 años de edad con psoriasis en placas crónica grave que no hayan respondido a tratamientos sistémicos no biológicos, que sean intolerantes a ellos o que estén contraindicados
    E.2.2Secondary objectives of the trial
    To assess the long term safety and tolerability of secukinumab in this pediatric age group and will describe the efficacy and safety of secukinumab compared to etanercept.
    To provide efficacy and safety data to support the extension of label of secukinumab to include children and adolescents (6 years to <18 years) with severe chronic plaque psoriasis

    Other protocol-defined secondary objectives may apply.
    Evaluar la seguridad y tolerabilidad a largo plazo de secukinumab en este grupo de edad pediátrica y describirá la eficacia y la seguridad de secukinumab en comparación con etanercept.
    Proporcionar datos de eficacia y seguridad para respaldar la extensión de la ficha técnica de secukinumab para incluir niños y adolescentes (de 6 a < 18 años de edad) con psoriasis en placas crónica grave.
    Referirse al protocolo para ver más objetivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Must be 6 to less than 18 years of age at the time of randomization
    2) Severe plaque-type psoriasis meeting all of the following three criteria:
    PASI score of 20 or greater,
    Investigator's Global Assessment (IGA) score of 4 or greater
    Total body surface area (BSA) affected of 10% or greater.
    3) Subjects who failed to respond to, or have a contraindication or are intolerant to non-biologic systemic therapies

    Other protocol-defined inclusion criteria may apply
    1. Deben tener de 6 a < 18 años de edad en el momento de la aleatorización.
    2. Psoriasis en placas grave, definida como una puntuación PASI ? 20 e IGA mod. 2011 ? 4, y afectación de la ASC ?10%.
    3. Antecedentes de psoriasis en placas durante al menos 3 meses.
    4. Pacientes que no hayan respondido a tratamientos sistémicos no biológicos, que sean intolerantes a ellos o que estén contraindicados.
    E.4Principal exclusion criteria
    1) Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
    2) Current drug-induced psoriasis.
    3) Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
    4) Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
    5) History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
    6) Pregnant or nursing (lactating) women.

    Other protocol-defined inclusion/exclusion criteria may apply.
    1. Formas de psoriasis salvo psoriasis en placas crónica (p. ej., psoriasis pustulosa, eritrodérmica y gutata).
    2. Psoriasis inducida por fármacos (es decir, nueva aparición o exacerbación actual por betabloqueantes, bloqueadores de los canales de calcio o litio).
    3. Exposición previa a secukinumab o a cualquier otro fármaco biológico directamente dirigido contra IL-17 o el receptor de IL-17, o a etanercept
    4. Enfermedades subyacentes (incluyendo entre otras enfermedades metabólicas, hematológicas, renales, hepáticas, pulmonares, neurológicas, endocrinas, cardíacas, infecciosas o gastrointestinales) que, según el criterio del investigador, inmunocomprometan de forma significativa al paciente y/o le coloca en una situación de riesgo inaceptable para recibir tratamiento inmunomodulador
    5. Se deberá seguir el criterio del investigador en el caso de pacientes con trastornos desmielinizantes del sistema nervioso central o periférico preexistentes o de aparición reciente.
    6. Mujeres embarazadas o en periodo de lactancia,

    Referirse al protocolo para ver más criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of Participants achieving a 75% Improvement from Baseline in PASI Score. The percentage of Participants who showed Investgator's Global Assessment (IGA) mod 2011 response of 0 or 1
    ? Porcentaje de pacientes que alcancen una mejoría (reducción) ?75% en la puntuación PASI en comparación con la basal. Porcentaje de pacientes que muestren una respuesta IGA 0 o 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    semana 12
    E.5.2Secondary end point(s)
    1. Percentage of Participants achieving a 90% Improvement from baseline in PASI score
    2. Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score
    3. Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an IGA mod 2011 score of 0 or 1
    4. Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score
    5. Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score.
    6. Percentage of participants achieving a Childrens' DLQI score of 0 or 1
    7. Patients' safety. Clinical safety and tolerability as assessed by growth, weight gain, tolerability of s.c. injections, vital signs, clinical laboratory variables, ECGs, and adverse events monitoring
    1. Porcentaje de pacientes que alcancen un PASI90 con respecto a la visita basal
    2. Porcentaje de pacientes que alcancen un PASI50, PASI100 con respecto a la visita basal
    3. Porcentaje de pacientes que alcancen un PASI50,75,90 o 100 PASI100 con respecto a la visita basal y un IGA mod 2011 de 0 o 1
    4. Porcentaje de pacientes que alcancen un PASI y un IGA mod 2011 de 0 o 1
    5. Cambio con respecto a visita basal del Children's Dermatology Life Quality Index (cDLQI)
    6. Porcentaje de pacientes que alcancen DLQI de 0 o 1
    7. Investigar la seguridad y tolerabilidad clínicas de secukinumab con respecto al crecimiento, el aumento de peso, la tolerabilidad a inyecciones s.c., las constantes vitales, las variables clínicas de laboratorio, los ECG y la monitorización de acontecimientos adversos en comparación con placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 12 weeks
    2. 12 weeks
    3. Weeks 1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52
    4. Baseline, week 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
    5. Weeks 2, 4. 8, 12, 24, 36, 52
    6. Weeks 2, 4. 8, 12, 24, 36, 52
    7. from screening to Week 252
    1-12 semanas
    2-12 semanas
    3-semanas1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48 y 52
    4. Basal, semana 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, y 52
    5. semanas 2, 4. 8, 12, 24, 36, 52
    6. semanas 2, 4. 8, 12, 24, 36, 52
    7. desde la selección hasta 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 No
    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 trial5
    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 EEA47
    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
    Belgium
    Brazil
    Colombia
    Egypt
    Estonia
    France
    Germany
    Guatemala
    Hungary
    Israel
    Italy
    Japan
    Latvia
    Poland
    Romania
    Spain
    United Kingdom
    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 years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 160
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 130
    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
    Paediatric subjects that may require parental permission (depending on local regulations)
    Pacientes pediátricos que requieran permiso paterno (dependiendo de la legislación local)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 160
    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)
    When subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.
    Una vez finalizado el estudio el investigador comentará con el paciente los diferentes tratamientos o posibles alternativas disponibles para tratar la psoriasis del paciente
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-14
    P. End of Trial
    P.End of Trial StatusOngoing
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