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    Summary
    EudraCT Number:2010-021239-15
    Sponsor's Protocol Code Number:CAIN457C2399
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-17
    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 number2010-021239-15
    A.3Full title of the trial
    Estudio multicéntrico, abierto para evaluar el uso clínico a largo plazo del tratamiento con AIN457 en pacientes que finalicen los ensayos clínicos en los que se investiga AIN457 para el tratamiento de la uveítis no infecciosa intermedia, posterior o panuveitis (Estudio SUPPORT)
    A.3.2Name or abbreviated title of the trial where available
    SUPPORT, C2399
    A.4.1Sponsor's protocol code numberCAIN457C2399
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/060/09; EU/3/09/724
    D.3 Description of the IMP
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uveítis crónica no infecciosa intermedia, posterior o panuveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Permitir la recogida de datos de seguridad e información adicionales sobre el uso clínico a más largo plazo de AIN457 en pacientes con uveítis del segmento posterior hasta que se comercialice el producto o se interrumpa el desarrollo de AIN457 en esta indicación o durante un período de 2 años después de que el último paciente sea reclutado en el estudio
    • Determinar la proporción de pacientes que cumplan los criterios de uveítis clínicamente inactiva del segmento posterior
    • Determinar el tiempo medio para cumplir los criterios de uveítis clínicamente inactiva del segmento posterior
    E.2.2Secondary objectives of the trial
    • Determinar la proporción de pacientes que presenten uveítis clínicamente activa del segmento posterior en pacientes a quienes se les retire el tratamiento con AIN457
    • Determinar el tiempo medio hasta la recurrencia de uveítis clínicamente activa del segmento posterior en pacientes a quienes se les retire el tratamiento con AIN457
    • Determinar si una recurrencia de uveítis clínicamente activa en pacientes a quienes se les retire el tratamiento con AIN457 se puede controlar únicamente reiniciando la inhibición de IL-17A inhibición con AIN457
    • Determinar la tasa de recurrencias de uveítis clínicamente activa del segmento posterior en este estudio abierto y la tasa de recurrencias en pacientes reclutados en ensayos clínicos con AIN457 durante la duración total del tratamiento del estudio (estudios del protocolo principal + estudios de extensión + estudio abierto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Los pacientes deben ser capaces de comprender y comunicarse con el investigador y cumplir los requisitos del estudio y deberán otorgar su consentimiento informado firmado y fechado por escrito antes de que se realice ninguna de las evaluaciones del estudio.
    2. Los pacientes actualmente reclutados en CAIN457A2208 o que hayan finalizado los períodos de tratamiento del estudio tanto del protocolo principal como de extensión en cualquiera de los ensayos clínicos de fase III con AIN457 en curso, estudios CAIN457C2301 y CAIN457C2301E1, CAIN457C2302 y CAIN457C2302E1, o CAIN457C2303 y CAIN457C2303E1.
    3. Estar dispuesto a interrumpir AIN457 o a que se le retire la terapia inmunosupresora de referencia si así lo recomienda el investigador del estudio.
    E.4Principal exclusion criteria
    1. Necesidad de tratamiento con procedimientos oculares o medicaciones sistémicas prohibidas en este estudio, incluidos un agente alquilante u otra terapia biológica distinta a AIN457.
    2. No puede o no está dispuesto a recibir inyecciones subcutáneas repetidas.
    3. Incapacidad para cumplir los procedimientos del estudio
    4. Mujeres embarazadas o en período de lactancia, donde el embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado mediante el resultado positivo de la prueba de laboratorio de hCG (> 5 mUI/mL)
    5. Mujeres en edad fértil (WoCBP), definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, EXCEPTO SI:
    • Están utilizando simultáneamente métodos anticonceptivos de doble barrera o dos métodos anticonceptivos aceptables (p. ej., dispositivo intrauterino más preservativo, preservativo más gel espermicida, diafragma más preservativo, etc., se acepta la sustitución hormonal ya sea como anticonceptivo oral o implantable como único método), desde el momento del reclutamiento y durante todo el estudio, hasta la finalización del estudio y durante las 16 semanas posteriores a la retirada de la medicación del estudio. [Nota: La abstinencia periódica (p. ej., calendario, ovulación, métodos sintotérmicos, postovulación), los espermicidas solos sin preservativos o capuchón cervical y la marcha atrás no se consideran métodos anticonceptivos aceptables.]
    • Están en período postmenopáusico con un perfil clínico apropiado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) y no han tenido hemorragia menstrual regular durante al menos doce (12) meses antes de la administración inicial. Se deberá confirmar la menopausia mediante un nivel de FSH en plasma de >40 UI/L en la selección
    • Se han sometido a esterilización quirúrgica fiable al menos seis (6) meses antes de la administración inicial. Los procedimientos de esterilización quirúrgica se deberían respaldar facilitando documentación clínica al promotor y/o al Investigador Principal, y se deberían anotar en el apartado de Antecedentes Médicos Relevantes / Enfermedades Actuales del CRD.
    • Su carrera profesional, estilo de vida u orientación sexual excluye el coito con un varón.
    • Las parejas han sido esterilizados mediante vasectomía u otro método fiable.
    E.5 End points
    E.5.1Primary end point(s)
    Las variables principales de eficacia relacionadas con los objetivos principales de eficacia son las siguientes:

    • Proporción de pacientes que cumplan todos o los primeros 2 criterios de uveítis clínicamente inactiva del segmento posterior a partir de la visita basal del estudio abierto
    • El tiempo medio para cumplir todos o los 2 primeros criterios de uveítis clínicamente inactiva del segmento posterior a partir de la visita basal del estudio abierto
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA19
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El ensayo se llevará a cabo hasta que se comercialice el producto o se interrumpa el desarrollo de AIN457 en esta indicación o durante un período de 2 años después de que el último paciente sea reclutado en el estudio (lo que ocurra primero).
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 535
    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 Decision2010-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-03-28
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