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    Summary
    EudraCT Number:2006-005455-15
    Sponsor's Protocol Code Number:CACZ885D2304
    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:2007-03-05
    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 number2006-005455-15
    A.3Full title of the trial
    Estudio multicéntrico de tres partes, con un diseño de retirada en la Parte II, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia, seguridad, y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1β ) en pacientes con Síndrome de Muckle-Wells
    A.4.1Sponsor's protocol code numberCACZ885D2304
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ACZ885
    D.3.4Pharmaceutical form Powder and solvent 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 - proposed
    D.3.9.2Current sponsor codeACZ885
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent 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
    Sindrome Muckle-Wells (Enfermedad Autoinflamatoria)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064569
    E.1.2Term Muckle-Wells 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 pacientes que recaen) de ACZ885 comparado con placebo de la Parte II determinada mediante la evaluación global de la actividad de la enfermedad autoinflamatoria por el médico, la evaluación de la enfermedad cutánea y marcadores inflamatorios (proteína C reactiva (PCR) y/o amiloide A sérico (SAA).
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad, tolerabilidad e inmunogenicidad de ACZ885. Evaluar la eficacia general (tasa de respuesta) de ACZ885 de la Parte I y la Parte III determinada mediante la evaluación global de la actividad de la enfermedad autoinflamatoria por el médico, la evaluación de la enfermedad cutánea y marcadores inflamatorios. Evaluar la farmacocinética (PK) y farmacodinámica (PD) de ACZ885. Evaluar el efecto de ACZ885 en la progresión de la enfermedad en lo que se refiere a sordera, función renal, síntomas neurológicos y oftalmológicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    De la lista completa del protocolo:

    Diagnóstico molecular de mutaciones NALP3 y cuadro clínico que parece MWS.

    Pacientes hombres o mujeres de edades comprendidas entre 4 y 75 años en el momento de la visita de selección.

    Los pacientes que estén en terapia con anakinra o cualquier otra bloqueante de la IL-1 en investigación, deberán estar dispuestos a retirar el tratamiento.
    E.4Principal exclusion criteria
    De la lista completa del protocolo:

    Uso de las siguientes terapias:
    • Etanercep en las 4 semanas previas a la visita basal (día 1)
    • Adalimumab en las 8 semanas previas a la visita basal (día 1)
    • Infliximab en las 12 semanas previas a la visita basal (día 1)
    • Cualquier otro biológico en investigación en las 8 semanas previas a la visita basal (día 1) (exceptuando terapia con anakinra y terapias bloqueantes de la IL-1 –véase más abajo)
    • Los pacientes que estén tomando terapias biológicas bloqueantes de la IL-1 (incluyendo terapia de anakinra) tienen que retirar este tratamiento. Tan pronto como se cumplan los criterios de recaída, los pacientes podrán entrar en el estudio y recibir tratamiento de ACZ885. Esta fase run-in reduce la fase típica de lavado a un tiempo médicamente significativo y evita sufrimiento innecesario para el paciente en el caso de que un periodo de lavado predefinido por protocolo sea demasiado largo para un sujeto.
    • Leflunomida en las 4 semanas previas a la visita basal (día 1)
    • Talidomida en las 4 semanas previas a la visita basal (día 1)
    • Ciclosporina en las 4 semanas previas a la visita basal (día 1)
    • Inmunoglobina i.v. (Ig i.v.) en las 8 semanas previas a la visita basal (día 1)
    • 6-mercaptopurina, azatioprina, ciclofosfamida, o clorambucil en las 12 semanas previas a la visita basal (día 1)
    • Colchicina, dapsona, micofenolato mofetil en las 3 semanas previas a la visita basal (día 1)
    • Corticoesteroides ≥ 20 mg/día ó > 0,4 mg/kg, el que proceda, en la semana previa a la visita basal (día 1)
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la proporción de pacientes con agudización de la enfermedad en el periodo de retirada (Parte II). Los pacientes que se retiren prematuramente del estudio en la fase de retirada debido a cualquier motivo se considerarán como si se hubiese agudizado la enfermedad.
    El objetivo principal del estudio es mostrar la superioridad de ACZ885 comparada con placebo respecto a la variable principal de la Parte II. Se comparará los dos grupos de tratamiento utilizando una prueba exacta (basándose en las probabilidades hipergeométricas) sobre el odds ratio común, ajustados por cohorte. La hipótesis nula a comprobar es que el odds ratio común es igual a 1, es decir, la probabilidad de agudización de la enfermedad es la misma para ambos grupos frente a que el odds ratio común no es igual a 1, es decir, la probabilidad de agudización de la enfermedad es diferente para ambos grupos. Se calculará el valor p bilateral exacto, el odds ratio común y el intervalo exacto de confianza del 95% para el odds ratio común. El análisis principal se basará en la población ITT de la Parte II.
    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 No
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity assessment
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Randomised withdrawal design. Double blind in Part II.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 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 al final de la parte III. Al final de la parte III está planeado una extensión para permitir a los pacientes continuar con el tratamiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parents consent or guardins consent mandatory.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 47
    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)
    Se ha planeado una extensión.
    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 Decision2007-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-29
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