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    Summary
    EudraCT Number:2020-003119-88
    Sponsor's Protocol Code Number:SECURA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial 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 number2020-003119-88
    A.3Full title of the trial
    EVALUATION OF AUTOIMMUNITY IN PSORIASIS FOLLOWING IL-17A NEUTRALIZATION: A BASE TO OPTIMISE USE OF BIOLOGICS IN PSORIASIS
    Valutazione dell’autoimmunità nella psoriasi dopo inibizione di IL-17A al fine di ottimizzare l’uso dei biologici nella psoriasi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    n.a.
    n.a.
    A.3.2Name or abbreviated title of the trial where available
    SECURA
    SECURA
    A.4.1Sponsor's protocol code numberSECURA
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Farma S.p.A.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Clinico Humanitas
    B.5.2Functional name of contact pointDipartimento di Scienze Biomediche
    B.5.3 Address:
    B.5.3.1Street AddressVia Alessandro Manzoni, 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.6E-mailjessica.avagliano@humanitas.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMetotressato
    D.3.2Product code [n.d.]
    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 INNMETOTREXATO
    D.3.9.1CAS number 59-05-2
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETOTREXATO
    D.3.9.1CAS number 59-05-2
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 Yes
    D.2.1.1.1Trade name COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN PENNA PRERIEMPITA - USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML) - 2 PENNE PRERIEMPITE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 [n.d.]
    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 875356-43-7
    D.3.9.2Current sponsor coden.d.
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe plaque psoriasis
    psoriasi a placche da moderata a grave
    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 20.0
    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
    Explore the value of T-cell responses to LL37 and ADAMTSL5 auto-antigens in psoriasis and the impact of IL-17A inhibition on these responses.
    Esplorare il ruolo della risposta T cellulare agli auto-antigeni LL37 e ADAMTSL5 nella psoriasi e quale sia l’impatto dell’inibizione di IL-17A sulla risposta T cellulare.
    E.2.2Secondary objectives of the trial
    Explore the value of LL37 and ADAMTSL5 auto-antibody formation in psoriasis and the effects of IL17A inhibition.
    Explore the phenotype of autoreactive T cells following IL17A inhibition by secukinumab.
    Esplorare il ruolo della formazione di autoanticorpi anti-LL37 e anti-ADAMTSL5 nella psoriasi e l’effetto sugli stessi dell’inibizione di IL-17A.
    Esplorare il fenotipo delle cellule T auto-reattive dopo inibizione di IL-17A a seguito di trattamento con secukinumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject has provided informed consent.
    Subject is =18 and = 80 years of age at time of screening.
    Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator).
    Subject has an SI index >2 for LL37 and/or ADAMTSL5 at baseline.
    Patients negative to LL37 and ADAMTSL5 will be included in the study to receive secukinumab but will be only clinically evaluated (PASI, IGA).
    Subject has involved body surface area (BSA) = 10%, PASI = 10, at baseline .
    For women (except those at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
    Subject has no known history of active tuberculosis.
    Subject has a negative test for tuberculosis during screening defined as either:
    negative purified protein derivative (PPD) (< 5 mm of induration at 48 to 72 hours after test is placed).
    OR
    negative Quantiferon test.
    Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test.
    Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
    no symptoms per tuberculosis worksheet provided by the Sponsor.
    documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations.
    no known exposure to a case of active tuberculosis after most recent prophylaxis .
    no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product.
    Subject is a candidate for systemic therapy or phototherapy.
    Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, cyclosporine, psoralen plus ultraviolet light [UV] A).
    Subject should not be previously treated with secukinumab or other biologics for psoriasis.
    Subject is able to complete study procedures, including self-assessments and self-injections.
    • Il soggetto ha fornito il consenso informato.
    • Il soggetto ha un'età =18 e = 80 anni al momento dello screening.
    • Il soggetto ha avuto una psoriasi a placche stabile da moderata a grave per almeno 6 mesi (p. Es., Nessun cambiamento morfologico o riacutizzazione significativa dell'attività della malattia secondo il parere dello sperimentatore).
    • Il soggetto ha un indice SI> 2 per LL37 e / o ADAMTSL5 al basale.
    • I pazienti negativi a LL37 e ADAMTSL5 saranno inclusi nello studio per ricevere secukinumab ma saranno valutati solo clinicamente (PASI, IGA).
    • Il soggetto ha una superficie corporea interessata (BSA) = 10%, PASI = 10, al basale.
    • Per le donne (eccetto quelle da almeno 2 anni in postmenopausa o chirurgicamente sterili): un test di gravidanza su siero negativo durante lo screening e un test di gravidanza sulle urine negativo al basale.
    • Il soggetto non ha una storia nota di tubercolosi attiva.
    • Precedente fallimento, risposta inadeguata, intolleranza o controindicazione ad almeno 1 terapia sistemica antipsoriasica convenzionale (p. Es., Ciclosporina, psoralene più luce ultravioletta [UV] A).
    • Il soggetto non deve essere precedentemente trattato con secukinumab o altri farmaci biologici per la psoriasi.
    E.4Principal exclusion criteria
    Skin disease related
    Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
    Other medical conditions SEE PROTOCOL
    • Malattia della pelle correlata
    • Soggetti con diagnosi di psoriasi eritrodermica, psoriasi pustolosa, psoriasi guttata, psoriasi indotta da farmaci o altre condizioni della pelle al momento della visita di screening (ad es. Eczema) che potrebbero interferire con le valutazioni dell'effetto del prodotto in studio sulla psoriasi.
    • Il soggetto ha un intervento chirurgico pianificato durante la durata dello studio.
    • Il soggetto ha un'infezione attiva o una storia di infezioni ricorrenti o - Il soggetto ha una storia nota di virus dell'immunodeficienza umana
    • Soggetto non controllato, clinicamente significativo
    • Il soggetto ha una storia di ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti di secukinumab
    E.5 End points
    E.5.1Primary end point(s)
    T-cell Proliferation index to LL37 or ADAMTSL5 autoantigens at day 0 week 16, week 28 and at week 52.
    Indice di proliferazione delle cellule T agli autoantigeni LL37 o ADAMTSL5 al giorno 0, settimana 16, settimana 28 e settimana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    PASI score at Weeks 16, 28 and 52
    PASI 90 response at Weeks 16, 28 and 52
    Presence and titer of autoantibodies against LL37 in patient’s sera. Presence and titer of autoantibodies against ADAMTSL5 in patient’s sera. Autoreactive T cells Phenotype shift to Treg
    Punteggio PASI alle settimane 16, 28 e 52
    Risposta PASI 90 alle settimane 16, 28 e 52
    Presenza e titolo di autoanticorpi contro LL37 nei sieri dei pazienti. Presenza e titolo di autoanticorpi contro ADAMTSL5 nei sieri dei pazienti. Cellule T autoreattive Spostamento del fenotipo a Treg
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    exploratory study
    studio esplorativo
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    End of the study is the date of the last visit or last scheduled procedure for the last patient.
    La fine dello studio è la data dell'ultima visita o dell'ultima procedura programmata per l'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 80
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    n.a.
    n.a.
    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 Decision2021-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
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