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    Summary
    EudraCT Number:2010-022228-66
    Sponsor's Protocol Code Number:CAIN457A2303
    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:2012-01-12
    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 number2010-022228-66
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, con
    doble enmascaramiento, controlado con placebo para
    demostrar la eficacia después de 12 semanas de
    tratamiento de secukinumab subcutáneo comparado
    con placebo y etanercept, y evaluar la seguridad,
    tolerabilidad y eficacia a largo plazo en el periodo de un
    año en sujetos con psoriasis en placas crónica de
    moderada a grave
    FIXTURE
    (Investigación de un año de duración sobre
    secukinumab frente a etanercept utilizando dos
    pautas posológicas para determinar la eficacia
    en psoriasis)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ensayo que evalua la seguridad y eficaccia del Secukinumab comparado con Etanercept en sujetos con psoriasus en placas crónica de modera a grave
    A.3.2Name or abbreviated title of the trial where available
    FIXTURE
    A.4.1Sponsor's protocol code numberCAIN457A2303
    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 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 AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica S.A
    B.5.2Functional name of contact pointICRO Head
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064342
    B.5.5Fax number0034933064290
    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 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 nameSekukinumab
    D.3.2Product code AIN457
    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 INNSekukinubad
    D.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal recombinante
    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 ENBREL 50 mg solución inyectable en jeringas precargadas
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.9.3Other descriptive nameETANERCEPT
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 typemedicamento recombinante
    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 placeboPowder for solution for injection
    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
    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
    Psoriasis común
    E.1.1.1Medical condition in easily understood language
    La psoriasis es una enfermedad que produce lesiones escamosas de color rojo
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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
    Demostrar la superioridad de secukinumab comparado con placebo en sujetos con psoriasis enplacas crónica de moderada a grave con respecto a las respuestas PASI 75 e IGA 0 o 1 (los
    dos criterios de valoración principales) en la semana 12.
    E.2.2Secondary objectives of the trial
    Demostrar la no inferioridad de secukinumab comparado con etanercept en sujetos con
    psoriasis en placas crónica de moderada a grave con respecto a la respuesta PASI 75 en la
    semana 12.
    Demostrar la superioridad de secukinumab comparado con placebo en sujetos con
    psoriasis en placas crónica de moderada a grave con respecto a la respuesta PASI 90 en la
    semana 12.
    Demostrar la superioridad de secukinumab comparado con etanercept en sujetos con
    psoriasis en placas crónica de moderada a grave con respecto a la respuesta PASI 75 y la
    respuesta IGA 0 o 1 en la semana 12.
    Demostrar la superioridad de secukinumab comparado con etanercept en el
    mantenimiento de la respuesta PASI 75 en la semana 52 en sujetos que eran
    respondedores PASI 75 en la semana 12.
    Demostrar la superioridad de secukinumab comparado con etanercept en el
    mantenimiento de la respuesta IGA 0 o 1 en la semana 52 en sujetos que eran
    respondedores IGA 0 o 1 en la semana 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los sujetos deben poder entender y comunicarse con el investigador y cumplir con los
    requisitos del estudio (incluida la administración de inyecciones s.c. en casa) y deben dar
    un consentimiento informado por escrito, firmado y fechado antes de que se realice
    cualquier actividad relacionada con el estudio. Cuando proceda un representante legal
    firmará también el consentimiento informado del estudio según la normativa local.
    2. Hombres o mujeres de al menos 18 años de edad en el momento de la selección.
    3. Psoriasis en placas crónica diagnosticada al menos 6 meses antes de la aleatorización.
    4. Psoriasis de moderada a grave en la aleatorización definida según:
    Puntuación PASI de 12 o superior y,
    Puntuación IGA mod. 2011 de 3 o superior (basada en una escala de 0 4) y,
    Área de superficie corporal (ASC) afectada por psoriasis en placas del 10% o
    superior.
    5. Candidatos para tratamiento sistémico, definidos como aquellos que tienen psoriasis en
    placas crónica que se considera inadecuadamente controlada por:
    Tratamiento tópico o
    Fototerapia o
    Tratamiento sistémico previo
    E.4Principal exclusion criteria
    Formas de psoriasis salvo psoriasis en placas crónica (p. ej., psoriasis pustulosa,
    eritrodérmica y en gotas).
    2. Psoriasis provocada por fármacos (es decir nueva aparición o exacerbación actual por
    betabloqueantes, inhibidores de los canales de calcio o litio).
    3. Uso actual de tratamientos prohibidos para la psoriasis (p. ej., corticoides (CS) tópicos os
    sistémicos, tratamiento UV). Se deben cumplir los periodos de lavado descritos en el
    protocolo (Tabla 5-1).
    4. Uso actual de otros tratamientos prohibidos que no sean para la psoriasis. Se deben
    cumplir los periodos de lavado descritos en el protocolo (Tabla 5-1). El resto de
    tratamientos previos concomitantes que no sean para la psoriasis deben mantener una
    dosis estable durante al menos cuatro semanas antes de la aleatorización.
    5. Exposición previa a secukinumab u otro fármaco biológico dirigido contra la IL-17 o el
    receptor de la IL-17.
    6. Exposición previa a etanercept.
    7.Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el
    estado de la mujeres después de la concepción y hasta que finalice la gestación,
    confirmado por un resultado positivo en la prueba hCG (> 5 mUI/ml)
    8. Las mujeres potencialmente fértiles, definidas como todas las mujeres fisiológicamente
    capaces de quedarse embarazadas salvo que utilicen un método anticonceptivo eficaz
    durante el estudio y durante las 16 semanas posteriores a la finalización del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Las variables principales de eficacia principal son respuesta PASI 75 en la semana 12 y
    respuesta IGA 0 o 1 en la semana 12. El análisis de las variables principales se basará en
    el FAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 semanas
    E.5.2Secondary end point(s)
    -PASI y IGA
    -seguridad clínica y tolerabilidad del sekunimab
    - Cambios en la calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    Respectivamente:
    - 12 semanas
    - 12 semanas
    - 12 semanas y 52 semanas
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 Yes
    E.8.1.7.1Other trial design description
    Doble enmascarado
    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 trial4
    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 EEA77
    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
    Australia
    Brazil
    Canada
    Colombia
    Guatemala
    India
    Korea, Republic of
    Peru
    Russian Federation
    Singapore
    Turkey
    United States
    Venezuela, Bolivarian Republic of
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 1201
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 486
    F.4.2.2In the whole clinical trial 1264
    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)
    Cuando el paciente termine el estudio, el investigador informará al paciente de l as diferentes medicaciones o posibles alternativas que hay disponibles para el tratamiento de la psoriasis.
    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 Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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