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    Summary
    EudraCT Number:2012-000046-35
    Sponsor's Protocol Code Number:CAIN457F2310
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000046-35
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis
    Studio multicentrico di fase III, randomizzato, in doppio cieco, controllato verso placebo per dimostrare l ï ½efficacia a 16 settimane di secukinumab, somministrato sottocute mediante siringhe pre-riempite, e per valutare la sicurezza, la tollerabilita e l efficacia a lungo termine fino a 5 anni in soggetti con spondilite anchilosante attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)
    Studio per dimostrare l'efficacia a 16 settimane di secukinumab, somministrato sottocute mediante siringhe pre-riempite, e per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine fino a 5 anni in soggetti con spondilite anchilosante attiva
    A.4.1Sponsor's protocol code numberCAIN457F2310
    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 FARMA
    B.1.3.4CountryItaly
    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
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@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 AIN457F
    D.3.4Pharmaceutical form 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 INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    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 AIN457F
    D.3.4Pharmaceutical form 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 INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    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 number75
    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
    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 placeboSolution 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
    Ankylosing spondylitis
    spondilite anchilosante
    E.1.1.1Medical condition in easily understood language
    Bechterev syndrome, Marie-Strümpell disease
    sindrome di Bechterev, malattia di 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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    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
    Measure the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo
    Dimostrare che l’efficacia di secukinumab 75 mg o 150 mg somministrato sottocute (s.c.) alla settimana 16 è superiore a placebo nei soggetti con AS attiva basata sulla proporzione di soggetti che raggiungono la risposta ASAS 20 (criteri di valutazione da parte della Società Internazionale sulla Spondiloartrite) nel sottogruppo di soggetti che non hanno mai ricevuto un trattamento con inibitori del TNFα
    E.2.2Secondary objectives of the trial
    1) Measure the proportion of subjects achieving an ASAS 20 response in the whole study population compared to placebo at week 16 2) Measure the proportion of subjects achieving an ASAS 40 response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo 3) Measure the proportion of subjects achieving an ASAS 40 response in the whole study population compared to placebo at week 16
    1. Dimostrare che l’efficacia di almeno un regime di secukinumab (75 mg s.c. o 150 mg s.c.) alla settimana 16 è superiore al placebo in soggetti con AS attiva basata sulla proporzione di soggetti che raggiungono la risposta ASAS 20 nell’intera popolazione in studio; 2. Dimostrare che l’efficacia di almeno un regime di secukinumab (75 mg s.c. o 150 mg s.c.) alla settimana 16 è superiore al placebo in soggetti con AS attiva basata sulla proporzione di soggetti che raggiungono la risposta ASAS 40 nei soggetti che non hanno mai ricevuto un trattamento con inibitori del TNFα; 3. Dimostrare che l’efficacia di almeno un regime di secukinumab (75 mg s.c. o 150 mg s.c.) alla settimana 16 è superiore al placebo in soggetti con AS attiva basata sulla proporzione di soggetti che raggiungono la risposta ASAS 40 nell’intera popolazione in studio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:00
    Date:2012/05/31
    Title:Protocol Title: A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long-term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis
    Objectives:The study includes an exploratory pharmacogenetic-biomarkers assessment which requires a signature of a separate informed consent.

    FARMACOGENETICA:
    Vers:00
    Data:2012/05/31
    Titolo:Titolo del Protocollo: Studio multicentrico di fase III, randomizzato, in doppio cieco, controllato verso placebo per dimostrare l’efficacia a 16 settimane di secukinumab, somministrato sottocute mediante siringhe pre-riempite, e per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine fino a 5 anni in soggetti con spondilite anchilosante attiva
    Obiettivi:Lo studio comprende una valutazione di biomarcatori-farmacogenetica esplorativa di cui richiede una firma in un consenso informato separato.

    E.3Principal inclusion criteria
    1) Male or non-pregnant, non-lactating female patients at least 18 years of age 2) Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) 3) Patients should have been on NSAIDs with an inadequate response 4) Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose 5) Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response
    • Uomini o donne, non in gravidanza o in allattamento, di età maggiore o uguale a 18 anni; • Diagnosi di AS da moderata a severa, con documentata precedente evidenza radiologica, in grado di soddisfare i criteri di New York modificati per la AS; • I pazienti devono essere stati trattati con FANS con risposta inadeguata; • I pazienti che stanno assumendo regolarmente FANS come parte della loro terapia per la AS, dovranno assumerli in dose stabile da almeno due settimane prima della randomizzazione; • I pazienti che sono stati in terapia con un farmaco anti-TNFα (non più di uno) devono avere evidenziato una risposta inadeguata.
    E.4Principal exclusion criteria
    1) Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process 2) Patients with total ankylosis of the spine 3) Patients previously treated with any biological immunomodulating agents except for those targeting TNFα 4) Previous treatment with any cell-depleting therapies Other protocol-defined exclusion criteria may apply.
    I pazienti che presentano uno o più dei seguenti criteri non sono eleggibili all’inclusione in questo studio: • Radiografia del torace o risonanza magnetica con evidenza di processi infettivi o neoplasie in atto; • Precedente esposizione a secukinumab o ad altri farmaci diretti contro la interleuchina 17 o il suo recettore; • Pazienti precedentemente trattati con qualsiasi altro farmaco immunomodulante con l’eccezione di farmaci diretti contro il TNFα; • Qualsiasi precedente terapia in grado di determinare deplezione cellulare.
    E.5 End points
    E.5.1Primary end point(s)
    ASAS 20 in subgroup of patients who are TNFα ''inibitore naïve''
    ASAS 20 in sottogruppo di pazienti che sono TNFα ''inhibitor naïve''
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    E.5.2Secondary end point(s)
    1) ASAS 20 in whole study population 2) ASAS 40 in subgroup of patients who are TNFα inhibitor naïve 3) ASAS 40 in whole study population
    1) ASAS 20 in tutta la popolazione in studio 2) ASAS 40 nel sottogruppo di pazienti che sono TNFα inibitori naïve 3) ASAS 40 in tutta la popolazione in studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Canada
    Russian Federation
    Singapore
    Switzerland
    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 21/AUG/2018
    LVLS 21/08/2018
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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.1.1Number of subjects for this age range: 0
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    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 leave 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.
    Il ricercatore deve fornire l'assistenza medica necessaria per tutti i soggetti che lasciano lo studio, o devono fare loro da riferimento per la cura medica più appropriata. Questa cura medica può comprendere l'inizio di un altro trattamento fuori dello studio come ritenuto più appropriato dal ricercatore. Questo trattamento può essere un DMARD non biologico. Nel caso di un trattamento biologico, un periodo di attesa di 3 mesi prima dell'inizio del trattamento è raccomandato.
    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 Decision2012-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-18
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