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    Summary
    EudraCT Number:2015-004620-60
    Sponsor's Protocol Code Number:CAIN457A2324
    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:2021-09-10
    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 number2015-004620-60
    A.3Full title of the trial
    A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and
    tolerability of sub-cutaneous secukinumab in subjects of body weight 90 kg or higher with moderate to severe chronic plaque-type psoriasis.
    Studio multicentrico, randomizzato, in doppio cieco, per valutare l’efficacia a breve (16 settimane) e a lungo termine (fino a 1 anno), la sicurezza e la tollerabilità di secukinumab s.c. in soggetti con peso uguale o maggiore di 90 kg e affetti da psoriasi cronica a placche di grado moderato e severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of secukinumab 1 mL pre-filled syringe (300 mg) in subjects of body weight 90 kg or higher with moderate to severe plaque psoriasis.
    Studio per valutare efficacia, sicurezza e tollerabilità di secukinumab s.c. in soggetti con peso uguale o maggiore di 90 kg e affetti da psoriasi cronica a placche di grado moderato e severo
    A.3.2Name or abbreviated title of the trial where available
    Study of efficacy and safety of secukinumab 1 mL pre-filled syringe (300 mg) in subjects of body wei
    Studio di efficacia e sicurezza di secukinumab s.c. in soggetti con peso uguale o maggiore di 90 kg
    A.4.1Sponsor's protocol code numberCAIN457A2324
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 PHARMA AG
    B.1.3.4CountrySwitzerland
    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 Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma SpA
    B.5.2Functional name of contact pointRegulatory 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 number0296541
    B.5.5Fax number029659066
    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 Yes
    D.2.1.1.1Trade name COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA
    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 [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.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
    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 di grado moderato e severo
    E.1.1.1Medical condition in easily understood language
    Psoriasis looks like red, raised scaly areas of skin
    La psoriasi si presenta come aree cutanee squamose rosse e sollevate
    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 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 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
    To compare efficacy, safety and tolerability of secukinumab 300 mg every 2 weeks to secukinumab 300 mg every 4 weeks in subjects with moderate to severe chronic plaque-type psoriasis and body weight of 90 kg or higher, and to explore the option of exposure escalation for those subjects who do not achieve the therapeutic goal at the dose regimen of 300 mg every 4 weeks.
    Dimostrare l’efficacia di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane, in termini di risposta PASI 90 alla settimana 16.
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of secukinumab 300 mg every 2 weeks in comparison to secukinumab 300 mg every 4 weeks with respect to Investigator's Global Assessment (IGA) mod 2011 0 or 1 response at Week 16.
    To investigate the clinical safety and tolerability of secukinumab 300 mg every 2 weeks in comparison to 300 mg every 4 weeks.
    Dimostrare l’efficacia di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane, in termini di risposta IGA 0/1 (Investigator’s Global assessment mod. 2011) alla settimana 16.
    Valutare la sicurezza e la tollerabilità di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane durante le 52 settimane di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
    2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
    3. Men or women at least 18 years of age at time of screening.
    4. Body weight of =90 kg at the time of randomization.
    5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
    6. Moderate to severe psoriasis as defined at randomization by:
    • Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
    • IGA mod 2011 score of 3 or greater (based on a static scale of 0 – 4), and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
    7. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
    • topical treatment and/or,
    • phototherapy and/or,
    • previous systemic therapy.
    1. Soggetti che abbiano fornito il proprio consenso informato scritto prima di ogni esame e/o valutazione.
    2. Soggetti capaci di comprendere e comunicare con lo sperimentatore, e che siano in grado di eseguire tutte le procedure e le visite previste dallo studio.
    3. Uomini o donne di almeno 18 anni di età compiuti al momento dello screening.
    4. Peso corporeo = 90 kg al momento della randomizzazione.
    5. Psoriasi cronica a placche presente da almeno 6 mesi e diagnosticata prima della randomizzazione.
    6. Psoriasi cronica di grado da moderato a severo al momento della randomizzazione definita da:
    • Punteggio PASI =12 e
    • Body Surface Area (BSA) =10% e
    • Punteggio IGA mod 2011 =3
    7. Pazienti candidabili alla terapia sistemica, definiti come affetti da psoriasi non adeguatamente controllata da:
    • trattamenti topici e/o
    • fototerapia e/o
    • precedente terapia sistemica
    E.4Principal exclusion criteria
    1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
    2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to as per protocol Table 5-1. Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.
    3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting interleukin (IL-17) or the IL-17 receptor.
    4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
    5. Pregnant or nursing (lactating) women
    6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
    7. History of hypersensitivity to any of the study drug constituents.
    • Forme di psoriasi diverse da quella cronica a placche (es. psoriasi pustolosa, eritrodermica e guttata) allo screening o alla randomizzazione.
    • Utilizzo in corso di studio di trattamenti proibiti dal protocollo. I periodi di wash-out necessari e dettagliati nel protocollo devono essere rispettati (cfr. Tab. 5-1 del protocollo). Il rifiuto da parte del soggetto di non voler limitare l’esposizione alla luce UV durante lo studio (per esempio prendere il sole e/o l'uso di dispositivi abbronzanti) è considerato un criterio di non eleggibilità. Nota: l’utilizzo di vaccini vivi in concomitanza con lo studio o nelle 6 settimane precedenti la randomizzazione non è permesso.
    • Precedente trattamento con secukinumab (AIN457) o con altri farmaci biotecnologici che hanno come target diretto l’IL-17 o il suo recettore (IL-17R).
    • Utilizzo di qualsiasi altro farmaco sperimentale al momento dell’arruolamento o nelle 4 settimane precedenti, o nel periodo pari a 5 emivite dall’entrata in studio.
    • Donne in gravidanza accertata o in allattamento.
    • Condizioni cliniche (incluse ma non limitate a quelle di tipo metabolico, ematologico, renale, epatico, polmonare, neurologico, endocrino, cardiaco, infettivo o gastrointestinale) che, secondo giudizio dello sperimentatore, compromettono significativamente il sistema immunitario del paziente e/o mettono il paziente ad un livello di rischio inaccettabile per ricevere una terapia immunomodulante. Patologie concomitanti gravi progressive o non controllate che, secondo giudizio dello sperimentatore, rendono il paziente non adatto allo studio o ne aumentano il rischio. Qualunque condizione medica o psichiatrica che, secondo giudizio dello sperimentatore, possa precludere al partecipante di aderire al protocollo o completare lo studio in accordo al protocollo.
    • Pazienti con una funzionalità renale gravemente ridotta (VFG stimato inferiore a 29 ml/min/1.73m2).
    • Infezioni sistemiche attive (escluso il raffreddore comune) nelle ultime 2 settimane che precedono il basale e qualunque infezione che ricorra su base regolare.
    • Storia di patologia infettiva in atto, cronica o ricorrente o evidenza di tubercolosi definita da un Quantiferon TB-Gold test (QFT), allo Screening, positivo o con esito inderminato.
    • Evidenza in anamnesi pregressa o concomitante di infezione da virus dell’immunodeficienza umano (HIV), evidenza di epatite B o epatite C prima della randomizzazione.
    • Anamnesi di malattie linfoproliferative o di qualsiasi neoplasia maligna nota o storia nota negli ultimi 5 anni di patologia neoplastica maligna trattata o non trattata, indipendentemente dalla presenza o meno di recidiva locale o metastasi (ad eccezione dei seguenti casi: malattia cutanea di Bowen, o carcinoma delle cellule basali o cheratosi attinica, trattati e con evidenza di mancata recidiva nelle precedenti 12 settimane; carcinoma in situ della cervice o poliposi benigna del colon sottoposta a rimozione chirurgica).
    E.5 End points
    E.5.1Primary end point(s)
    PASI 90
    PASI 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Week 16
    E.5.2Secondary end point(s)
    IGA mod 2011 0 or 1 response

    Clinical safety and tolerability ; IGA mod 2011 0 or 1 response
    Clinical safety and tolerability
    GA mod 2011 0 or 1 response

    Clinical safety and tolerability; IGA mod 2011 0 or 1 response
    Sicurezza e tollerabilità clinica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16

    Week 52; Week 16
    Week 52
    Week 16

    Week 52; Settimana 16
    Settimana 52
    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 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 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 trial2
    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 EEA17
    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 Information not present in EudraCT
    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
    Russian Federation
    United States
    Germany
    Hungary
    Italy
    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
    LVLS
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 106
    F.4.2.2In the whole clinical trial 330
    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 available medications and alternative treatment options for psoriasis with the subject.
    When the subject leaves the study, the investigator will discuss available medications and alternative treatment options for psoriasis with the subject.
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
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