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    Summary
    EudraCT Number:2012-000985-39
    Sponsor's Protocol Code Number:CAIN457A2304E1
    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:2012-09-26
    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 number2012-000985-39
    A.3Full title of the trial
    A multicenter, double-blind and open label, 2 year extension study of subcutaneous secukinumab in prefilled syringes, assessing long-term safety, tolerability and efficacy in subjects with moderate to severe chronic plaque-type psoriasis treated with either a fixed dose regimen or on a retreatment at start of relapse regimen
    Studio di estensione multicentrico della durata di due anni, in parte in doppio cieco e in parte in aperto, per dimostrare la sicurezza, la tollerabilita e l efficacia di secukinumab per via sottocutanea in siringhe pre-riempite in soggetti con psoriasi cronica a placche da moderata a severa, trattati con un regime ad intervalli fissi o con un regime di ritrattamento alla comparsa di una recidiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study of Secukinumab Prefilled Syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding Secukinumab Phase III studies
    Studio di estensione in soggetti con psoriasi cronica a placche da moderata a severa, che hanno completato precedenti studi di fase III con secukinumab in seringhe preriempite.
    A.4.1Sponsor's protocol code numberCAIN457A2304E1
    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 (VA)
    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 AIN457A
    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.3.9.2Current sponsor codeAIN457A
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    psoriasis
    psoriasi
    E.1.1.1Medical condition in easily understood language
    psoriasis
    psoriasi
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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 evaluate the number and percentage of subjects having any AE
    Valutare il numero e la percentuale di soggetti con eventi avversi.
    E.2.2Secondary objectives of the trial
    1) To evaluate change in PASI 75 responses 2) To evaluate Investigator Global Asessment (IGA) Response 3) To evaluate change in Quality of Life Response
    1) Valutare i cambiamenti nel PASI 75 2) Valutare IGA 3) Valutare i cambiamenti nel ''Dermatology Life Quality Index'' (DLQI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations. 2) Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307 3) Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator Other protocol-defined inclusion criteria may apply.
    I soggetti che soddisfino ciascuno dei seguenti criteri sono ritenuti idonei a partecipare a questo studio: 1)I soggetti devono essere in grado di intendere e di comunicare con lo sperimentatore, devono rispettare i requisiti dello studio e devono fornire il consenso informato scritto, firmato e datato prima che sia svolta qualsiasi attività correlata allo studio. Ove necessario, un rappresentante legale controfirmerà il consenso informato come previsto dalle normative vigenti. 2)I soggetti che hanno completato la settimana 52 dello studio CAIN457A2304 oppure la settimana 40 dello studio CAIN457A2307. 3)Soggetti per cui è atteso un beneficio dalla partecipazione a questo studio di estensione, secondo l’opinione del soggetto stesso e dello sperimentatore.
    E.4Principal exclusion criteria
    1) A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject 2) Ongoing use of prohibited psoriasis or nonpsoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. 3) Subjects expected to be exposed to an undue safety risk if participating in the trial 4) Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial 5) Plans for administration of live vaccines during the study period 6) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL). Other protocol-defined exclusion criteria may apply.
    I soggetti che soddisfino uno qualsiasi dei seguenti criteri sono considerati NON idonei alla partecipazione a questo studio: 1) Una deviazione di protocollo negli studi core che, ad opinione dello sperimentatore, possa compromettere l’analisi dei risultati del singolo soggetto. 2)Utilizzo di trattamenti anti-psoriasici o non anti-psoriasici proibiti dal protocollo. Il tempo di interruzione di ciascun trattamento proibito prima dell’assunzione della prima dose del farmaco di questo studio di estensione deve essere rispettato così come indicato nella tabella 5-2 del protocollo. 3)I soggetti per cui la partecipazione allo studio comporterebbe l’esposizione ingiustificata a rischi sulla sicurezza. 4)Patologie gravi in corso, progressive o incontrollate, che a giudizio dello sperimentatore rendano il soggetto non idoneo alla partecipazione allo studio. 5)Somministrazione programmata di vaccini 6)Donne in gravidanza o in allattamento, dove la gravidanza è intesa dal concepimento fino al termine della gestazione, confermata dalla positività al test di laboratorio (hCG &gt; 10 mIU/mL). 7) Donne potenzialmente fertili, ovvero fisiologicamente in grado di portare a termine una gravidanza e che non intendano utilizzare metodi di contraccezione efficace durante il periodo di studio e fino alle 16 settimane successive al termine del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The number and percentage of subjects having any AE, having an AE in each primary system organ class and having each individual AE
    Valutazione di tutti gli eventi avversi e gli eventi avversi seri, incluse le reazioni nel sito d’iniezione
    E.5.1.1Timepoint(s) of evaluation of this end point
    104 weeks
    104 settimane
    E.5.2Secondary end point(s)
    1) Change in PASI 75 responses 2) Investigator Global Asessment (IGA) Response 3) Change in DLQI©, EQ-5D©, and HAQ©-DI responses
    1) Cambiamenti nelle risposte del PASI 75 2) Investigator Global Asessment (IGA) Risposte 3) Cambiamenti nelle risposte del DLQI©, EQ-5D©, e HAQ©-DI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 92, Week 104, Week 144, Week 156 2) week 104 3) Baseline, week 104
    1) Settimana 92, Settimana 104, Settimana 144, Settimana 156 2) Settimana 104 3) Basale, settimana 104
    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 No
    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 Yes
    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 trial5
    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 EEA59
    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
    India
    Japan
    Singapore
    United States
    Vietnam
    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
    LPLV : 12/MAY/2015
    LPLV : 12/MAG/2015
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months28
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months32
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 740
    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)
    standard
    standard
    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 Decision2012-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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