Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42559   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005154-57
    Sponsor's Protocol Code Number:CACZ885D2307E1
    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:2012-01-27
    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 number2011-005154-57
    A.3Full title of the trial
    An open-label extension study to assess efficacy, safety and tolerability
    of canakinumab and the efficacy and safety of childhood vaccinations in
    patients with Cryopyrin Associated Periodic Syndromes (CAPS)
    Estudio de extensión abierto para evaluar la eficacia, seguridad y tolerabilidad de canakinumab y la eficacia y seguridad de las vacunas pediátricas en pacientes con Síndrome Periódico Asociado a Criopirina (CAPS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study to check how safe, beneficial and tolerable the drug
    canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).
    Estudio de extensión para comprobar cómo de seguro, tolerable y beneficioso es el Canakinumab para pacientes con síndrome asociado a criopirina administrado junto a vacunas infantiles
    A.3.2Name or abbreviated title of the trial where available
    D2307E1
    D2307E1
    A.4.1Sponsor's protocol code numberCACZ885D2307E1
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/208/2011
    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 pointInma Bosch
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de las Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064351
    B.5.5Fax number0034933064274
    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 ILARIS
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/439
    D.3 Description of the IMP
    D.3.1Product namecanakinumab
    D.3.2Product code ACZ885
    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 INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.2Current sponsor codeACZ885
    D.3.9.4EV Substance CodeSUB30137
    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 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
    Cryopyrin Associated Periodic Syndromes (CAPS)
    Síndrome Periódico Asociado a Criopirina (CAPS)
    E.1.1.1Medical condition in easily understood language
    CAPS is a group of inflammatory disorders (causing redness, swelling, pain and fever) caused by the body making too much of a protein called interleukin 1B (IL-1B)
    CAPS es un grupo de trastornos inflamatorios (que produce enrojecimiento, inflamación, dolor y fiebre) causado por la síntesis de una proteína llamada interleuquina 1Beta (IL-1Beta)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10068850
    E.1.2Term Cryopyrin associated periodic syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term efficacy of canakinumab with respect to the maintenance of treatment response in CAPS patients who completed the CACZ885D2307 study
    Evaluar la eficacia a largo plazo de canakinumab con respecto a la recidiva en pacientes con CAPS que hayan finalizado el estudio CACZ885D2307
    E.2.2Secondary objectives of the trial
    - Safety and tolerability as assessed by the overall frequency of adverse events and the number of patients completing the extension study in the overall population
    - To assess the presence of protective antibody levels following
    immunization with inactivated (killed) vaccines administered during the extension study
    - To assess the safety of canakinumab treatment in pediatric patients receiving a concomitant vaccination during the extension study
    - To assess the proportion of patients with vaccination-associated
    reactions during the extension study
    - To assess efficacy with regards to the Physician's Global Assessment of autoinflammatory disease activity and assessment of skin disease
    - To evaluate the efficacy of canakinumab with regards to inflammatory markers (C-reactive protein (CRP) or serum amyloid A (SAA)
    [...]
    - Seguridad y tolerabilidad evaluadas por la frecuencia global de acontecimientos adversos y el número de pacientes que finalicen el estudio de extensión en la población global
    - Evaluar la presencia de niveles de anticuerpos protectores después de la inmunización con vacunas inactivadas (muertas) administradas durante el estudio de extensión
    - Evaluar la seguridad del tratamiento con canakinumab en pacientes pediátricos que reciban una vacuna concomitante durante el estudio de extensión
    - Evaluar la proporción de pacientes con reacciones asociadas a la vacunación durante el estudio de extensión
    - Evaluar la eficacia con respecto a la evaluación global del médico de la actividad de la enfermedad autoinflamatoria y la evaluación de la enfermedad cutánea
    - Evaluar la eficacia de canakinumab con respecto a marcadores de la inflamación (proteína C reactiva (PCR) o amiloide A sérico (AAS)
    [..... ]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
    2.Male and female patients that are ≥ 1 year of age at the time of the roll-over visit.
    3.Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.
    1. Pacientes que finalizaron el estudio principal CACZ885D2307 (se define que un paciente ha finalizado el estudio principal si ha finalizado el estudio hasta e incluida la visita EOS sin
    desviaciones importantes del protocolo en el estudio principal).
    2. Pacientes hombres y mujeres que tengan ? 1 año de edad en el momento de la visita de inclusión.
    3. Deberá obtenerse el consentimiento informado por escrito del padre/madre o tutor legal antes de realizar ninguna evaluación en el estudio de extensión CACZ885D2307E1.
    E.4Principal exclusion criteria
    1.Patients for whom continued treatment in the CACZ885D2307E1
    extension study is not considered appropriate by the treating physician.
    2.Patients who discontinued from the core CACZ885D2307 study.
    1. Pacientes para los que el tratamiento continuado en el estudio de extensión CACZ885D2307E1 no se considere apropiado a juicio del médico tratante.
    2. Pacientes que fueron retirados del estudio principal CACZ885D2307.
    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)
    To assess the long-term efficacy of canakinumab with respect to the maintenance of treatment response in CAPS patients who completed the CACZ885D2307 study
    Evaluar la eficacia a largo plazo de canakinumab con respecto al mantenimiento de la respuesta al tratamiento en pacientes con CAPS que completaron el estudio CACZ885D2307
    E.5.1.1Timepoint(s) of evaluation of this end point
    A minimum of 6 months and maximum of 24 months
    un mínimo de 6 meses y un máximo de 24 meses
    E.5.2Secondary end point(s)
    - Safety and tolerability as assessed by the overall frequency of adverse events and the number of patients completing the extension study in the overall population
    - To assess the presence of protective antibody levels following
    immunization with inactivated (killed) vaccines (see Section 6.1 of
    protocol) administered during the extension study
    - To assess the safety of canakinumab treatment in pediatric patients receiving a concomitant vaccination during the extension study
    - To evaluate the proportion of patients with vaccinated-associated
    reactions
    - To assess efficacy with regards to the Physician's Global Assessment of autoinflammatory disease activity and assessment of skin disease
    - To assess the reduction of inflammation marker (C-reactive protein (CRP) or serum amyloid A (SAA) after treatment initiation
    - Seguridad y tolerabilidad evaluadas por la frecuencia global de acontecimientos adversos y el número de pacientes que finalicen el estudio de extensión en la población global
    - Evaluar la presencia de niveles de anticuerpos protectores después de la inmunización con vacunas inactivadas (muertas) administradas durante el estudio de extensión
    - Evaluar la seguridad del tratamiento con canakinumab en pacientes pediátricos que reciban una vacuna concomitante durante el estudio de extensión
    - Evaluar la proporción de pacientes con reacciones asociadas a la vacunación durante el estudio de extensión
    - Evaluar la eficacia con respecto a la evaluación global del médico de la actividad de la enfermedad autoinflamatoria y la evaluación de la enfermedad cutánea
    - Evaluar la eficacia de canakinumab con respecto a marcadores de la inflamación (proteína C reactiva (PCR) o amiloide A sérico (AAS)..........
    E.5.2.1Timepoint(s) of evaluation of this end point
    A minimum of 6 months and maximum of 24 months
    un mínimo de 6 meses y un máximo de 24 meses
    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
    Assessment of Immunogenicity; Assessment of antibody titers against vaccine antigen
    Evaluación de la inmunogenicidad, evaluación de los títulos de anticuerpos contra el antígeno de la vacuna
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sólo hay una rama de tratamiento Canakinumab activo. Abierto
    There is only 1 treatment arm: Canakinumab. Open
    E.8.2.4Number of treatment arms in the trial1
    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 EEA9
    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
    Belgium
    Canada
    France
    Germany
    Israel
    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
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 16
    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.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 11
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 patients
    pacientes pediátricos
    F.3.3.7Others No
    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 13
    F.4.2.2In the whole clinical trial 16
    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)
    Upon availability of the approved and marketed drug for the pediatric CAPS population, patients will be
    offered to complete the study and roll-over into an open label registry study (CACZ885D2401), which
    will allow for the long-term assessment of safety and disease-modification.
    Cuando se disponga del fármaco aprobado y comercializado para la población pediátrica con CAPS, a los pacientes se les ofrecerá finalizar el estudio y ser reclutados en un estudio de registro abierto (CACZ885D2401), lo que permitirá la evaluación a largo plazo de la seguridad y la
    modificación de la enfermedad.
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-13
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA