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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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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    EudraCT Number:2013-005575-41
    Sponsor's Protocol Code Number:CAIN457F2320
    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:2016-03-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005575-41
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis
    A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis
    Efficacia, sicurezza e tollerabilità di un regime con carico vs. un regime senza carico di secukinumab sottocutaneo a confronto con placebo fino a 2 anni in pazienti con spondilite anchilosante (Ankylosing Spondylitis - AS) attiva
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCAIN457F2320
    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 S.P.A.
    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 Azienda Farmaceutica: Novartis Pharma Services AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA S.p.A.
    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 code21010
    B.5.4Telephone number0296541
    B.5.5Fax number029659066
    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
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 injector
    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 syndrom, Marie-Strümpell disea
    morbo 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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10002555
    E.1.2Term Ankles swollen
    E.1.2System Organ Class 100000004859
    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 secukinumab 150 mg at Week 16 with or without a loading regimen is superior to placebo based on the
    proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response.
    Dimostrare che l’efficacia di secukinumab 150 mg con o senza regime di carico, alla Settimana 16, sia superiore a placebo in base alla proporzione di soggetti che raggiungono una risposta ASAS20 (criteri della Assessment of SpondyloArthritis International Society).
    E.2.2Secondary objectives of the trial
    To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at Week 16 is superior to placebo based on
    •the proportion of subjects achieving an ASAS40 response
    •the change from baseline of high sensitivity C-Reactive Protein (hsCRP)
    •the proportion of patients meeting the ASAS 5/6 response criteria
    •the change from baseline in total Bath Ankylosing Spondylitis Disease Activity (BASDAI)
    •the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
    •the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
    -To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at
    Week 4 is superior to placebo based on:
    •the proportion of subjects achieving an ASAS20 response
    •the proportion of subjects achieving an ASAS40 response
    - Overall safety and tolerability of secukinumab
    Dimostrare che l’efficacia di secukinumab 150 mg s.c., con o senza carico, alla Settimana 16 sia superiore a placebo in base: - alla proporzione di pazienti che raggiungono una risposta ASAS40. - alla variazione rispetto al basale della proteina C-reattiva ad alta sensibilità (High Sensitivity C-Reactive Protein – hsCRP). -alla proporzione di pazienti che soddisfa i criteri di risposta ASAS 5/6. - alla variazione rispetto al basale nell’indice totale BASDAI (Bath Ankylosing Spondylitis Disease Activity Index). - alla variazione rispetto al basale nello Short Form-36 Physical Component Summary (SF-36 PCS). - alla variazione rispetto al basale
    dell’AnkylosingSpondylitis Quality of Life (ASQoL). Dimostrare che l’efficacia di secukinumab 150 mg s.c., con o
    senza carico, alla Settimana 4, sia superiore a placebo in base: - alla proporzione di pazienti che raggiunge una risposta ASAS20, - alla
    proporzione di soggetti che raggiunge una risposta ASAS40. Sicurezza e tollerabilità complessive
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory pharmacogenetics research studies are planned as a part of this study with the
    objectives of identifying inherited genetic factors which may (1) be related to AS, (2) predict
    response to treatment with secukinumab, (3) predict relative susceptibility to drug-drug
    interactions, or (4) predict genetic predisposition to side effects.
    v00 del 23.10.2014
    Indagine di Farmacogenetica
    Individuare i fattori genetici ereditari che possono (1) essere legati alla AS, (2) prevedere la risposta al trattamento con secukinumab, (3) prevedere la suscettibilità all'interazione farmaco-farmaco, o (4) prevedere la predisposizione genetica agli effetti collaterali.
    basata su protocollo originale v00 del 23.10.2014
    E.3Principal inclusion criteria
    - Moderate to severe AS
    - Prior radiographic evidence according to the Modified NY Criteria (1984)
    - Inadequate response to NSAIDs
    Other protocol-definied inclusion criteria may apply.
    Pazienti uomini o donne non in gravidanza o in allattamento di almeno 18 anni di età.
    Diagnosi di AS da moderata a severa con pregressa evidenza radiologica documentata (radiografia o referto del radiologo) che soddisfano i criteri “Modified New York criteria” per AS
    I pazienti devono essere stati in trattamento con FANS alla dose massima raccomandata per almeno 3 mesi con una risposta non adeguata o per meno di 3 mesi se il trattamento è stato sospeso per intolleranza, tossicità o controindicazioni.
    Ai pazienti che assumono regolarmente FANS come parte della loro terapia per AS si richiede di essere in trattamento a dose stabile da almeno 2 settimane prima della randomizzazione.
    I pazienti che sono stati in trattamento con un inibitore di TNFα (non più di uno) devono aver manifestato una risposta inadeguata o devono essere risultati intolleranti.
    E.4Principal exclusion criteria
    - Pregnancy or lactation
    - On-going 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-definied exclusion criteria may apply.
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri non sono eleggibili per l’inclusione in questo studio:
    Radiografia toracica o risonanza magnetica con evidenza di processo infettivo o maligno in corso.
    Precedente esposizione a secukinumab o a qualsiasi altro farmaco biologico avente come target diretto IL-17 o il recettore di IL-17.
    Pazienti precedentemente trattati con qualsiasi agente immunomodulatore biologico, ad eccezione degli agenti che hanno come bersaglio TNFα.
    Pazienti che hanno assunto più di un agente anti-TNFα.
    Pregresso trattamento con qualsiasi terapia di deplezione cellulare.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of Spondyloarthritis International Society criteria, ASAS 20
    Valutazione secondo i ciriteri della SpondyloArthritis International Society (ASAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 settimane
    E.5.2Secondary end point(s)
    - ASAS 40 response (a) - Serum hsCRP (a) - ASAS 5/6 response (a) - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (a) - Short Form-36 Physical Compenent Summary (SF-36 PCS) health survey (a) - Ankylosing Spondylitis Quality of Life (ASQoL) (a) - Overall safety and tolerability (b)
    - risposta ASAS40 (a) - hsCRP sierica (a) - risposta ASA5/6 (a) - BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (a) - Short Form-36 Physical Component Summary (SF-36 PCS) (a) - AnkylosingSpondylitis Quality of Life (ASQoL) (a) - sicurezza e tollerabilità (b)
    E.5.2.1Timepoint(s) of evaluation of this end point
    (a) 16 weeks (b) 112 weeks
    (a) 16 settimane (b) 112 settimane
    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. 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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.1.1.1In 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: 304
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 297
    F.4.2.2In the whole clinical trial 324
    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.
    L'investigatore deve fornire il follow-up delle cure mediche per tutti i soggetti che abbandonano prematuramente lo studio,o fornire riferimenti per
    adeguate cure in corso. Questa cura può rappresentare un altro trat. al di fuori dello studio, come ritenuto opportuno dal
    investigatore. Questo trat. può essere qualsiasi DMARD non biologico. Nel caso venga scelto un trat. biologico, si raccomanda di eseguire un periodo di sospensione dei trat. di 3 mesi prima di iniziare il nuovo trattamento.
    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 Decision2015-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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