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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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).

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    Summary
    EudraCT Number:2013-001090-24
    Sponsor's Protocol Code Number:CAIN457F2314
    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:2013-11-12
    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 number2013-001090-24
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis
    Estudio multicéntrico, aleatorizado, doble ciego fase III de Secukinumab, controlado con placebo para demostrar la eficacia a las 16 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo en un periodo de 3 años en sujetos con espondilitis anquilosante activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients
    Eficacia a las 16 semanas y seguridad, tolerabilidad y eficacia en un periodo de 3 años de secukinumab en pacientes con espondilitis anquilosante activa
    A.4.1Sponsor's protocol code numberCAIN457F2314
    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 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 pointDepartamento Medico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    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 nameSecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    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 No
    D.IMP: 2
    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 nameSecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 placeboSolution for injection in pre-filled syringe
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing spondylitis
    Espondilitis Anquilosante
    E.1.1.1Medical condition in easily understood language
    Bechterev syndrom, Marie-Strümpell disease
    Sindrome Bechterev, Enfermedad de Marie-Strümpell
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF alpha therapy.
    Demostrar que la eficacia de al menos una dosis de secukinumab en la semana 16 es superior a placebo en base a la proporción de sujetos que alcancen un ASAS 20 (criterios de la Sociedad Internacional de evaluación de la espondiloartritis) en sujetos con una EA activa a pesar de un tratamiento actual o previo con AINE, FAME y/o anti-TNF?.
    E.2.2Secondary objectives of the trial
    -To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on:
    1- the proportion of subjects achieving an ASAS 40 response
    2- the change from baseline of hsCRP
    3- the proportion of patients meeting the ASAS 5/6 response criteria
    4- the change from baseline in total BASDAI
    5- the change from baseline in the proportion of patients achieving ASAS partial remission
    -To assess PFS usability utilizing the Self-Injection assessment checklist and Possible Hazard assessment checklist and to assess subject satisfaction with PFS utilizing the SIAQ
    -Overall safety and tolerability of secukinumab LiV and PFS formulations compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring
    Demostrar que la eficacia de al menos una dosis de secukinumab en la semana 16 es superior a placebo en base a:
    1-la proporción de sujetos que logren una respuesta ASAS 40
    2-al cambio de la PCRus desde la basal
    3-la proporción de pacientes que logren una respuesta ASAS 5/6
    4-al cambio de BASDAI total desde la basal
    5-al cambio en la proporción de pacientes que logren una remisión parcial ASAS desde la basal
    Evaluar la usabilidad de la JPC utilizando la lista de comprobación de evaluación de autoinyección y la lista de comprobación de evaluación de posibles riesgos, y evaluar la satisfacción del sujeto con las JPG mediante el cuestionario de evaluación de autoinyección (SIAQ)
    La seguridad y tolerabilidad general de secukinumab en formulaciones LV y JPC comparadas con placebo evaluadas según las constantes vitales, los valores de laboratorio clínico y la monitorización de acontecimientos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Moderate to severe AS
    - Prior radiographic evidence according to the Modified NY Criteria (1984)
    - Inadequate response to NSDAIDs
    Other protocol-defined inclusion criteria may apply
    -Diagnóstico de EA de moderada a grave
    - evidencia con pruebas radiológicas documentadas previas que cumplan los criterios de New York modificados (1984)
    -Pacientes tratados con AINEs y que hayan mostrado una respuesta inadecuada
    Otros criterios de inclusion definidos en el protocolo
    E.4Principal exclusion criteria
    - Pregnancy or lactation
    - Ongoing infectious or malignant process on a chest X-ray or MRI
    - Previous exposure to IL-17 or IL-17R targeting therapies
    - Previous exposure to any biological immunomodulating agent excluding TNF antagonists
    - Previous cell depleting therapy
    Other protocol-defined exclusion critera may apply
    - embarazo o periodo de lactancia
    - Radiografía de tórax o RM con pruebas de un proceso infeccioso o maligno en curso
    - Exposición previa terapias dirigidas contra la IL-17 o el receptor de la IL-17.
    - Pacientes previamente tratados con cualquier agente biológico inmunomodulador, excepto los antagonistas al TNF?
    - Tratamiento previo con cualquier terapia de destrucción celular
    Otros criterios de exclusion definidos en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of Spondyloarthritis International Society criteria / ASAS 20 response
    Evaluación de los criterios de la Sociedad Internacional de evaluación de la espondiloartritis / respuesta ASAS 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    E.5.2Secondary end point(s)
    1- ASAS 40 response
    2- Serum hsCRP
    3- ASAS 5/6 response
    4- Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
    5- Pre-filled syringe usability, possible hazard and patient satisfaction assessment
    6- Overall safety and tolerability
    1- respuesta ASAS 40
    2- hsCRP sérica
    3- respuesta ASAS 5/6
    4- Índice de actividad para la espondilitis anquilosante de Bath / BASDAI
    5- usabilidad de la jeringa precargada,evaluación de posibles riesgos y evaluación la satisfacción del sujeto
    6- seguridad y tolerabilidad general
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4: 16 weeks
    5: Baseline to Week 16
    6: 156 weeks
    1 a 4: 16 semanas
    5: desde la Basal hasta la Semana 16
    6: 156 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 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 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 No
    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.8.2.4Number of treatment arms in the trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Czech Republic
    Germany
    Greece
    Portugal
    Spain
    Sweden
    Mexico
    Russian Federation
    United Kingdom
    United States
    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
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 222
    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)
    The investigator must provide follow-up medical care for all subjects who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study as deemed appropriate by the investigator. This treatment may be any non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.
    El investigador debe proporcionar un seguimiento de la atencion medica a aquellos pacientes que se retiren del estudio prematuramente, o debe referirlos para que reciban asistencia medica apropiada. Esta asistencia médica puede incluir el iniciar otro tratamiento fuera del ensayo segun se considere apropiado por el investigador. Este tratamiento puede ser cualquier FAME no biologico. En caso de tratamiento biologico, se recomienda esperar 3 meses.
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-11
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