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    Summary
    EudraCT Number:2009-016859-22
    Sponsor's Protocol Code Number:CACZ885D2307
    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:2010-06-30
    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 number2009-016859-22
    A.3Full title of the trial
    Ensayo multicéntrico abierto de un año de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de canakinumab (ACZ885) y la eficacia y seguridad de las vacunas pediátricas en pacientes de 4 años de edad o menores con Síndromes Periódicos Asociados a Criopirina (CAPS)
    A.4.1Sponsor's protocol code numberCACZ885D2307
    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 numberEU/3/07/439
    D.3 Description of the IMP
    D.3.1Product nameCANAKINUMAB
    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 INNCANAKINUMAB
    D.3.9.2Current sponsor codeACZ885
    D.3.9.3Other descriptive nameCANAKINUMAB
    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 Yes
    D.3.11.13.1Other medicinal product typeanticuerpo monoclonal antihumano de la interleucina 1B
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Síndromes Periódicos Asociados a Criopirina (CAPS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068850
    E.1.2Term Cryopyrin associated periodic syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de canakinumab respecto a la respuesta al tratamiento en pacientes con CAPS de 4 años de edad o menores
    E.2.2Secondary objectives of the trial
    • Evaluar eficacia de canakinumab respecto a la respuesta al tratamiento en pacientes de 2 años de edad o menores
    • Seguridad y tolerabilidad evaluada mediante la frecuencia global de acontecimientos adversos y el nº de pacientes que finalicen el estudio en pacientes de 2 años de edad y menores y en la población general
    • Evaluar la presencia de niveles de anticuerpos protectores tras la inmunización con vacunas inactivadas
    • Evaluar la seguridad del tratamiento con canakinumab en pacientes pediátricos que reciban una vacuna concomitante
    • La proporción de pacientes con reacciones asociadas a la vacunación
    • Evaluar el número de pacientes con recidiva determinada mediante la evaluación global del médico de la actividad de la enfermedad autoinflamatoria, la evaluación de la enfermedad cutánea y de los marcadores de la inflamación
    • Evaluar la reducción de los marcadores de la inflamación (proteína C reactiva (PCR) o amiloide A sérico (AAS) tras el inicio del tratamiento etc...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes hombres y mujeres que tengan entre 28 días hasta 60 meses de edad en el momento de la visita de selección.
    2. Peso corporal &#8805; 2,5 kg
    3. Se requiere el consentimiento informado por escrito del padre/madre o tutor legal antes de realizar ninguna evaluación a los pacientes.
    4. En el momento de la inclusión, los pacientes deberían tener un diagnóstico clínico de FCAS, MWS, o NOMID y síntomas que precisen intervención farmacológica. Se precisa un acuerdo previo entre el Investigador y Novartis para determinar la elegibilidad para participar en el estudio en el caso de los pacientes para los que no se disponga de un diagnóstico molecular de mutaciones de NALP3 (ya sea que no se haya realizado la prueba, o que se haya realizado la prueba pero el resultado haya sido negativo) en el momento de la inclusión en el estudio. En los pacientes a quienes no se les hayan realizado pruebas moleculares para determinar la presencia de mutaciones de NALP3, las pruebas moleculares se deberían realizar durante el transcurso del estudio.
    5. En el caso de los pacientes tratados con un bloqueador de la IL-1 (p. ej., anakinra, rilonacept), se deberían retirar estos tratamientos antes de la visita basal y se deberá demostrar que los pacientes presentan enfermedad activa antes del tratamiento.
    6. Los pacientes para los que se tenga programada la administración de inmunización, de acuerdo con sus guías de vacunación locales, mediante una vacuna inactivada deberán estar dispuestos a participar en el programa de evaluaciones para pacientes vacunados.
    E.4Principal exclusion criteria
    1. Recién nacidos prematuros para los que, a juicio del investigador, no se considere apropiada la participación en el estudio
    2. Antecedentes de recurrencia y/o evidencia de infecciones activas bacterianas, fúngicas o víricas (incluido el VIH)
    3. Pacientes con inmunodeficiencia o tratamiento con inmunosupresores
    4. Vacunas vivas en los &#8805;3 meses previos a la selección. No se permitirán vacunas vivas durante todo el transcurso de este estudio y hasta 3 meses después de la última dosis
    5. Pacientes con un mayor riesgo de infección por tuberculosis (TB) de acuerdo con los siguientes factores de riesgo:
    • Pacientes que recientemente han tenido contacto cercano con personas que se sabe que padecen tuberculosis pulmonar activa
    • Pacientes nacidos en el extranjero en países con una alta prevalencia de tuberculosis
    • Pacientes con infección reciente debido a tuberculosis (incluidos niños > 6 meses con una prueba PPD positiva [definida como una induración de al menos 10 mm])
    • Pacientes con enfermedad renal en fase terminal
    • Pacientes con diabetes mellitus
    • Pacientes que reciben tratamiento inmunosupresor
    • Pacientes con cánceres hematológicos
    6. Participación en otro ensayo en los últimos 30 días o 5 semividas del compuesto en investigación (el que sea más largo).
    7. Condiciones familiares y sociales que imposibiliten la evaluación médica periódica
    Para asegurar que la población del estudio será representativa de todos los pacientes elegibles, el investigador no podrá aplicar ninguna exclusión adicional.
    E.5 End points
    E.5.1Primary end point(s)
    Número de pacientes de 4 años de edad o menores respondedores al tratamiento.
    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 Yes
    E.6.13.1Other scope of the trial description
    inmunogenicidad
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Novartis puede finalizar el estudio en cualquier momento y por cualquier motivo. Si esto fuese necesario, se debería visitar al paciente lo antes posible y el paciente debería recibir tratamiento según se describe en el Apartado 6 relativo a la retirada prematura de un paciente. Al investigador se le podrá informar sobre los procedimientos adicionales a seguir para asegurar que la protección de los intereses del paciente se tienen debidamente en cuenta.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 15
    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 Decision2010-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-19
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