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    Summary
    EudraCT Number:2012-004019-29
    Sponsor's Protocol Code Number:CAIN457B2203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2013-01-11
    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 number2012-004019-29
    A.3Full title of the trial
    A Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis
    Studio di fase II, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato verso placebo, con disegno adattativo per la definizione della dose, per valutare l efficacia e la sicurezza di AIN457 (secukinumab) in pazienti con sclerosi multipla recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis
    Efficacia e sicurezza di AIN457 in pazienti con sclerosi multipla recidivante
    A.4.1Sponsor's protocol code numberCAIN457B2203
    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 AddressLgo 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 AIN457
    D.3.4Pharmaceutical form Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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: 3
    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 Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.2
    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: 4
    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 Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.8
    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: 5
    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 Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.6
    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: 6
    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 Powder 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.3.9.2Current sponsor codeAIN457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.3
    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 placeboPowder 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
    Relapsing multiple sclerosis
    sclerosi multipla recidivante
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis with relapses
    sclerosi multipla recidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10052785
    E.1.2Term Multiple sclerosis acute and progressive
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system 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 efficacy of multiple doses of AIN457 in reducing the number of new Gadolinium-enhancing lesions on MRI compared to placebo
    L’obiettivo primario è di definire la relazione dose-risposta relativa all’efficacia di AIN457 rispetto a placebo nella riduzione del numero cumulativo di nuove lesioni in T1 captanti gadolinio, evidenziate in tutte le Risonanze Magnetiche Nucleari (RMN) disponibili ai Mesi 3, 4, 5 e 6 in pazienti con RMS.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of multiple doses of AIN457
    Valutare la sicurezza e la tollerabilità di diverse dosi di AIN457
    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:2012/09/05
    Title:A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 (secukinumab) in patients with relapsing multiple sclerosis
    Objectives:n.a.

    PHARMACOGENOMIC:
    Vers:00
    Date:2012/09/05
    Title:come sopra
    Objectives:come sopra

    FARMACOGENETICA:
    Vers:00
    Data:2012/09/05
    Titolo:Studio di fase II, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato verso placebo, con disegno adattativo per la definizione della dose, per valutare l’efficacia e la sicurezza di AIN457 (secukinumab) in pazienti con sclerosi multipla recidivante
    Obiettivi:Vi informiamo che, anche se il protocollo non prevede sottostudi formalmente definiti (ovvero strutturati con un protocollo specifico) ma indagini complementari opzionali, gli stessi vengono classificati come sottostudi e quindi formalizzati nell’apposita sezione del CTA Form. Di seguito il dettaglio: • Indagine di farmacogenetica e farmacogenomica per studi esploratori, a cui parteciperanno tutti i centri italiani coinvolti nello studio. • Indagine di farmacocinetica e marcatori biologici nel liquido cefalorachidiano, a cui l’Italia non partecipa. L’eventuale non accettazione del sottostudio di farmacogenetica e farmacogenomica per studi esploratori da parte del Comitato Etico e/o da parte del paziente non comprometterà in alcun modo la partecipazione allo studio principale.

    FARMACOGENOMICA:
    Vers:00
    Data:2012/09/05
    Titolo:come sopra
    Obiettivi:come sopra

    E.3Principal inclusion criteria
    - Diagnosis of multiple sclerosis according to published criteria - Evidence of recent disease activity - Disease duration of no more than 10 years - EDSS score of 0 to 5.0
    Diagnosi di sclerosi multipla secondo i criteri McDonald rivisti del 2010 (ad esempio i pazienti con un primo evento demielinizzante possono essere eleggibili se soddisfano i criteri McDonald rivisti del 2010 per la diffusione nello spazio e nel tempo). Evidenza di attività di malattia recente definita come almeno una recidiva documentata nell’ultimo anno. Durata di malattia non superiore ai 10 anni dal primo sintomo correlato alla sclerosi multipla riportato. Punteggio EDSS da 0 a 5.0, estremi inclusi, allo screening/basale.
    E.4Principal exclusion criteria
    - Patients with an active chronic disease of the immune system other than multiple sclerosis or with a known immunodeficiency syndrome - History of malignancy - Patients with active infections - Patients who have been previously treated with more than one multiple sclerosis disease-modifying therapy - Patients who have been treated with: Interferon-beta or glatiramer acetate within 1 month prior to randomization; Natalizumab within 3 months prior to randomization; Fingolimod within 3 months prior to randomization; Immunosuppressive medications within 6 months prior to randomization; Rituximab within 2 years prior to randomization; Cyclophosphamide, mitoxantrone, or alemtuzumab at any time; Total white blood cells (WBC) count <2,500/microL, or lymphocytes <800/microL, or neutrophils <1,500/microL; Patients unable to undergo MRI scans, including claustrophobia; Pregnant or breast-feeding females
    1. Pazienti con malattia cronica attiva (o stabile ma trattata con terapia immunologica) del sistema immunitario diversa dalla sclerosi multipla (ad es. artrite reumatoide, sclerodermia, sindrome di Sjögren, malattia di Crohn, colite ulcerosa, ecc.) o con sindrome da immunodeficienza nota (AIDS, deficienza immunitaria ereditaria, deficienza immunitaria indotta da farmaci). 2. Anamnesi positiva per patologia maligna di un organo o sistema nei 5 anni precedenti (ad eccezione di carcinoma basocellulare cutaneo localizzato o della cheratosi attinica, trattati senza evidenza di recidiva nelle 12 settimane precedenti; carcinoma in situ della cervice o polipi del colon maligni non invasivi che sono stati rimossi), indipendentemente dalla presenza di evidenza di recidiva locale o metastasi. 3. Pazienti con infezioni sistemiche batteriche, virali o fungine attive. 4. Pazienti precedentemente trattati con più di un DMT (Disease Modifying Therapy). 5. Pazienti trattati con:  interferone beta o glatiramer acetato nel mese precedente la randomizzazione  natalizumab nei 3 mesi precedenti la randomizzazione  fingolimod nei 3 mesi precedenti la randomizzazione  farmaci immunosoppressori (ad es. azatioprina, metotrexate) nei 6 mesi precedenti la randomizzazione  rituximab nei 2 anni precedenti la randomizzazione  ciclofosfamide, mitoxantrone o alemtuzumab in qualsiasi momento 6. Conta totale dei globuli bianchi (WBC) &lt;2,500/μL, o linfociti &lt;800/μL, o neutrofili &lt;1,500/μL. 7. Pazienti non in grado di sottoporsi alle valutazioni tramite RMN, compresa claustrofobia o impossibilità a ricevere gadolinio-DTPA (ad es. ipersensibilità, disfunzione renale).
    E.5 End points
    E.5.1Primary end point(s)
    To define the dose-response efficacy relationship of AIN457, relative to placebo, in reducing the cumulative number of new Gadoliniumenhancing T1-weighted lesions recorded on all available MRI scans
    La variabile primaria di efficacia è il numero cumulativo di nuove lesioni in T1 captanti gadolinio osservate alle RMN effettuate ai Mesi 3, 4, 5 e 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At months 3, 4, 5 and 6
    ai mesi 3, 4, 5 e 6
    E.5.2Secondary end point(s)
    - To evaluate the safety and tolerability of multiple doses of AIN457, relative to placebo, in patients with relapsing multiple sclerosis - To evaluate the effect of AIN457, over a range of doses, on other parameters of disease activity as evaluated by MRI - To evaluate the effect of AIN457, over a range of doses, on clinical disease activity as evaluated by annualized relapse rate
    - Valutare la sicurezza e la tollerabilità di diverse dosi di AIN457, relativo al placebo, in pazienti con sclerosi multipla recidivante - Valutare l’effetto di diverse dosi di AIN457 su altri parametri di attività di malattia valutati tramite RMN - Valutare l’effetto di diverse dosi di AIN457 sull’attività clinica di malattia valutata tramite il tasso di recidiva annualizzato
    E.5.2.1Timepoint(s) of evaluation of this end point
    At months 0 to 6
    Ai mesi da 0 a 6
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Canada
    Colombia
    Japan
    Russian Federation
    Switzerland
    Turkey
    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 05.OCT.2015
    LVLS : 05.10.2015
    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 months34
    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: 470
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 470
    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 Decision2013-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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