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    Summary
    EudraCT Number:2012-000533-39
    Sponsor's Protocol Code Number:CAIN457A2302E1
    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:2012-09-03
    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 number2012-000533-39
    A.3Full title of the trial
    A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab
    Studio di estensione multicentrico, in doppio cieco, randomizzato, con disegno di sospensione del trattamento con secukinumab somministrato per via sottocutanea mediante siringhe pre-riempite, per dimostrare l'™efficacia, la sicurezza e la tollerabilita' fino a 2 anni in soggetti con psoriasi cronica a placche da moderata a severa che hanno completato i precedenti studi di fase III di secukinumab nella psoriasi.
    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 psoriasis phase III studies with secukinumab
    Studio di estensione multicentrico, in doppio cieco, randomizzato, con disegno di sospensione del trattamento con secukinumab somministrato per via sottocutanea mediante siringhe pre-riempite, per dimostrare l’efficacia, la sicurezza e la tollerabilità fino a 2 anni in soggetti con psoriasi cronica a placche da moderata a severa che hanno completato i precedenti studi di fase III di secukinumab nella psoriasi.
    A.4.1Sponsor's protocol code numberCAIN457A2302E1
    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 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.3.9.2Current sponsor codeAIN457
    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
    Moderate to severe chronic plaque-type psoriasis
    psoriasi cronica a placche da moderata a severa
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasis
    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 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 demonstrate the efficacy of secukinumab 150 mg or 300 mg in subjects with moderate to severe chronic plaque-type psoriasis, who were PASI 75 responders at Week 52 of the core study, with respect to loss of PASI 75 up to Week 68, compared to placebo.
    Dimostrare l’efficacia di secukinumab 150 mg o 300 mg in confronto a placebo nei soggetti con psoriasi cronica a placche da moderata a severa che hanno mostrato una risposta alla terapia ottenendo un punteggio PASI 75 alla settimana 52 dello studio core (responders), rispetto alla perdita del punteggio PASI 75 valutata fino alla settimana 68.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of secukinumab 150 mg or 300 mg with respect to PASI 50/75/90/100 response and IGA 0 or 1 response, compared to placebo over time in subjects who were PASI 75 responders at Week 52, over time for subjects who were re-treated after relapse with secukinumab 150 mg or 300 mg, and over time in subjects who were partial responders at Week 52. Other secondary objectives apply, please refer to the full protocol for details.
    • Valutare nel tempo l’efficacia di secukinumab 150 mg o 300 mg in confronto a placebo in termini di risposta PASI 50/75/90/100 e IGA 0 o 1 nei soggetti PASI 75 responders alla settimana 52, nei soggetti che sono stati trattati nuovamente con secukinumab 150 mg o 300 mg a seguito di recidiva (re-treated) e nei soggetti con risposta parziale alla terapia alla settimana 52 (partial responders). • Valutare nel tempo l’efficacia di secukinumab 150 mg o 300 mg in confronto a placebo in termini di risposta PASI e IGA mod 2011 nei soggetti PASI 75 responders alla settimana 52, nei soggetti re-treated con secukinumab 150 mg or 300mg a seguito di recidiva e nei soggetti partial responders alla settimana 52. • Valutare il tempo per ottenere una risposta PASI 75 nei soggetti re-treated con secukinumab 150 mg or 300mg a seguito di recidiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed the full study treatment period of 52 weeks in either of the two preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies. 2. Written informed consent form. Other protocol-defined inclusion criteria may apply
    I soggetti idonei a partecipare a questo studio dovranno rispettare tutti i seguenti criteri: 1. Soggetti che hanno completato l’intero periodo di trattamento (52 settimane) degli studi core (ad es. CAIN457A2302 o CAIN457A2303), che dopo la randomizzazione hanno ricevuto il trattamento con secukinumab durante la fase di mantenimento degli studi core e che hanno mostrato almeno una risposta parziale (PASI 50 o superiore) alla settimana 52 degli studi core. 2. Il consenso informato scritto deve essere ottenuto prima dell’effettuazione di qualsiasi valutazione.
    E.4Principal exclusion criteria
    1. A protocol deviation in either of the preceding phase III 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 non-psoriasis treatments. 3. 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). 4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. Other protocol-defined exclusion criteria may apply.
    I soggetti che rispetteranno uno qualsiasi dei seguenti criteri NON saranno idonei a partecipare a questo studio: 1. Una deviazione di protocollo negli studi core che, a giudizio dello sperimentatore, pregiudichi un’analisi significativa dello studio di estensione per il singolo soggetto. 2. Uso corrente di trattamenti proibiti, anti-psoriasici o non. Dovrà essere strettamente rispettato il periodo di sospensione successivo all’utilizzo nello studio core dei trattamenti proibiti, come descritto nella Tabella seguente (per favore vedere pag. 7 della sinossi in italiano)
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative rate of subjects who lost PASI75 response up to Week 68
    Frequenza cumulativa di soggetti che hanno perso la risposta PASI 75 fino alla settimana 68
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    Settimana 16
    E.5.2Secondary end point(s)
    - changes in PASI - IGA - time to PASI75 response - Hemoglobin count, hematocrit count, red blood cell count, white blood cell count with differential and platelet count - ECG - AEs - changes in QoL
    •Cambiamenti in PASI •Investigator’s Global Assessment (IGA) • tempo PASI75 risposta . emoglobina, ematocrito, globuli rossi, globuli bianchi, piastrine... • ECG . AEs • cambiamenti in QoL
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study at time points defined in the protocol
    In tutto lo studio ai tempi di rilevazione definiti nel protocollo
    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 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 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 EEA114
    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
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    Egypt
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Singapore
    Taiwan
    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 : 6.APR.2015
    LVLS : 06.04.2015
    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 months30
    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 months34
    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: 1170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 1240
    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)
    When the subject leaves the study, the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.
    Quando il paziente lascia lo studio, il medico ricercatore discuterà dei differenti farmaci o alternative possibili che sono a disposizione per trattare la psoriasi del paziente.
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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