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    Summary
    EudraCT Number:2019-000904-14
    Sponsor's Protocol Code Number:M19-164
    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:2021-06-17
    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 number2019-000904-14
    A.3Full title of the trial
    A Phase 3b, multicenter, interventional, open-label study of adult subjectswith moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab.
    Studio Multicentrico di Fase 3b, interventistico e In Aperto in Soggetti Adulti affetti da Psoriasi a Placche di Grado da Moderato a Grave con risposta subottimale a Secukinumab o a Ixekizumab e che vengono convertiti al trattamento con Risankizumab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety in patients who have been treated for at least 6 months with secukinumab or ixekizumab and have experienced a suboptimal response and then switched to risankizumab.
    Studio per valutare l’efficacia e la sicurezza in pazienti che sono stati trattati per almeno 6 mesi con secukinumab o ixekizumab, a cui hanno presentato una risposta subottimale, e che sono quindi stati convertiti a risankizumab.
    A.3.2Name or abbreviated title of the trial where available
    RISA Raise Standard of Care Study M19-164
    RISA Raise Standard of Care Study M19-164
    A.4.1Sponsor's protocol code numberM19-164
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameRisankizumab
    D.3.2Product code [ABBV-066]
    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 INNRISANKIZUMAB
    D.3.9.1CAS number 1612838-76-2
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG1 Monoclonal antibody
    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
    Plaque Psoriasis / Psoriasis Vulgaris
    Psoriasi a placche/Psoriasi vulgaris
    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
    The objective of this study is to evaluate the efficacy and safety of switching to risankizumab for subjects with moderate to severe plaque psoriasis who have been treated with labeled dose of secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response. Suboptimal response is defined as a static Physician's Global Assessment (sPGA) 2 or 3, and a Body Surface Area (BSA) 3% - < 10%after at least 6 months treatment with secukinumab or ixekizumab.
    L’obiettivo di questo studio è valutare l’efficacia e la sicurezza che si associano alla conversione a risankizumab in soggetti affetti da psoriasi a placche di grado da moderato a grave che sono stati trattati con secukinumab o ixekizumab alla dose indicata nella scheda tecnica per almeno 6 mesi e presentano una risposta subottimale. Per risposta subottimale si intende un punteggio sPGA (static Physician's Global Assessment } pari a 2 o 3, e percentuale di area di superficie corporea (BSA} interessata dalla malattia compresa fra 3% e < 10% dopo almeno 6 mesi di trattamento con secukinumab o ixekizumab.
    E.2.2Secondary objectives of the trial
    The proportion of subjects achieving a static Physician Global
    Assessment clear response (sPGA 0) at Week 16;
    • The proportion of subjects achieving a Dermatology Life Quality Index
    (DLQI) 0 or 1 at Week 16;
    • The proportion of subjects achieving a Psoriasis Symptoms Scale
    (PSS) 0 at Week 16;
    • The proportion of subjects achieving a sPGA 0/1 at Week 52;
    • The proportion of subjects achieving a sPGA 0 at Week 52;
    • The proportion of subjects achieving a DLQI 0/1 at Week 52;
    • The proportion of subjects achieving a PSS 0 at Week 52;
    • Time to achieve sPGA 0/1;
    • Time to achieve sPGA 0.
    • La percentuale di soggetti che ottengono una risposta indicativa di completa risoluzione delle lesioni (clear) in base al punteggio sPGA 0 (static Physician Global Assessment } alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio DLQI (Dermatology Life Quality Index) pari a 0 o 1 alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio PSS (Psoriasis Symptoms Scale) pari a 0 alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio sPGA pari a 0/1 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio sPGA pari a 0 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio DLQI pari a 0/1 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio PSS 0 alla Settimana 52;
    • Tempo fino al raggiungimento del punteggio sPGA pari a 0/1;
    • Tempo fino al raggiungimento del punteggio sPGA pari a 0.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Adult subjects 18 years and older at screening;
    * Diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0);
    * Subject must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing a sub-optimal response at time of Screening and Baseline visits
    * Sub-optimal response to Secukinumab and Ixekizumab inhibitors is defined as:
    - Body Surface Area (BSA) 3% - <10% and
    - Static Physician Global Assessment 2/3
    * Subject must be eligible for continued biologic therapy as assessed by the investigator
    • Soggetti di età pari o superiore a 18 anni allo screening;
    • Diagnosi di psoriasi a placche cronica di grado da moderato a grave da almeno 6 mesi prima del Baseline (Settimana 0);
    • Il soggetto deve essere stato in trattamento con secukinumab o ixekizumab in accordo alla rispettiva scheda tecnica per almeno 6 mesi e presentare una risposta subottimale al momento delle visite di Screening e Baseline
    • Per risposta subottimale agli inibitori Secukinumab e Ixekizumab si intende:
    - Percentuale di BSA interessata dalla psoriasi compresa fra 3% e < 10%, e
    - punteggio sPGA pari a 2 /3
    • Il soggetto deve essere idoneo, in base al giudizio dello sperimentatore, a proseguire la terapia con biologici
    E.4Principal exclusion criteria
    * History of erythrodermic psoriasis, generalized or localized pustular
    psoriasis, medication-induced or medication-exacerbated psoriasis, or
    new onset guttate psoriasis, psoriatic arthritis;
    * No active skin disease other than plaque psoriasis that could interfere
    with the assessment of plaque psoriasis;
    * History of chronic infections including HIV, viral hepatitis (hepatitis B,
    hepatitis C), and/ or active tuberculosis. Subjects with a positive
    QuantiFERON®-TB /PPD test result may participate in the study if
    further work up (according to local
    practice/guidelines) establishes conclusively that the subject has no
    evidence of active tuberculosis. If presence of latent tuberculosis is
    established, then treatment must have been initiated and maintained
    according to local country guidelines;
    * Active systemic infection during the last 2 weeks prior to Baseline Visit
    (exception: common cold) as assessed by the investigator;
    * History of any documented active or suspected malignancy or history
    of any malignancy within the last 5 years except for successfully treated
    non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the
    cervix;
    * History of major surgery performed within 12 weeks prior to
    randomization or planned to be performed during the conduct of the trial
    as assessed by the investigator;
    * Previous exposure to risankizumab or any IL-23 inhibitors.
    • Storia di psoriasi eritrodermica, psoriasi pustolosa generalizzata oppure localizzata, psoriasi indotta o esacerbata da farmaci oppure psoriasi guttata di nuova insorgenza, artrite psoriasica;
    • Assenza di patologia cutanea in fase attiva diversa dalla psoriasi a placche e tale da interferire con la valutazione della psoriasi a placche;
    • Storia di infezioni croniche fra cui HIV, epatite virale (epatite B, epatite C) e/o tubercolosi in fase attiva. I soggetti con risultato positivo al test QuantiFERON®-TB-PPD possono partecipare allo studio qualora ulteriori indagini (in accordo alla pratica/linee guida locali) accerti in maniera conclusiva che il soggetto non presenta alcuna evidenza di tubercolosi attiva. Qualora si accerti la presenza di tubercolosi latente, il trattamento deve essere stato avviato e deve essere mantenuto in accordo alle linee guida locali della nazione;
    • Infezione sistemica in fase attiva nelle ultime 2 settimane precedenti la visita di Baseline (eccezione: raffreddore), secondo la valutazione del medico sperimentatore;
    • Storia documentata di qualsiasi neoplasia maligna e attiva o sospetta, oppure storie di qualsiasi neoplasia maligna negli ultimi 5 anni ad eccezione del carcinoma cutaneo non melanoma (NMSC) oppure del carcinoma localizzato in situ della cervice uterina trattati con successo;
    • Storia di intervento chirurgico maggiore eseguito nelle 12 settimane precedenti la randomizzazione, oppure intervento chirurgico programmato nel corso della conduzione dello studio clinico, secondo quanto valutato dal medico sperimentatore;
    • Esposizione pregressa a risankizumab o a qualsiasi inibitore di IL-23.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving a static Physician's Global Assessment (sPGA) clear (0) or almost clear (1) response at Week 16
    La percentuale di soggetti che ottengono una risposta indicativa di completa risoluzione delle lesioni (clear, 0) o quasi completa (almost clear, 1) in base al punteggio sPGA (static Physician Global Assessment } alla Settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 16
    alla settimana 16
    E.5.2Secondary end point(s)
    * The proportion of subjects achieving a static Physician Global
    Assessment clear response (sPGA 0) at Week 16;
    * The proportion of subjects achieving a Dermatology Life Quality Index
    (DLQI) 0 or 1 at Week 16;
    * The proportion of subjects achieving a Psoriasis Symptoms Scale
    (PSS) 0 at Week 16;
    * The proportion of subjects achieving a sPGA 0/1 at Week 52;
    * The proportion of subjects achieving a sPGA 0 at Week 52;
    * The proportion of subjects achieving a DLQI 0/1 at Week 52;
    * The proportion of subjects achieving a PSS 0 at Week 52;
    * Time to achieve sPGA 0/1;
    * Time to achieve sPGA 0;
    • La percentuale di soggetti che ottengono una risposta indicativa di completa risoluzione delle lesioni (clear) in base al punteggio sPGA 0 (static Physician Global Assessment } alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio DLQI (Dermatology Life Quality Index) pari a 0 o 1 alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio PSS (Psoriasis Symptoms Scale) pari a 0 alla Settimana 16;
    • La percentuale di soggetti che ottengono un punteggio sPGA pari a 0/1 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio sPGA pari a 0 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio DLQI pari a 0/1 alla Settimana 52;
    • La percentuale di soggetti che ottengono un punteggio PSS 0 alla Settimana 52;
    • Tempo fino al raggiungimento del punteggio sPGA pari a 0/1;
    • Tempo fino al raggiungimento del punteggio sPGA pari a 0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 16
    Alla Settimana 16
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Aperto
    Open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Israel
    Taiwan
    United States
    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
    The end of study is defines as the date of the last subject's last contact, which will be a follow-up phone call 20 weeks after the last dose.
    Per fine dello studio si intende la data dell’ultimo contatto con l’ultimo soggetto, che sarà rappresentato da un contatto telefonico di follow-up 20 settimane dopo l’ultima dose
    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 months10
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days27
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects who complete or prematurely discontinue (PD) will be treated
    in accordance with the investigator's best clinical judgment. Those who
    complete the study, will have a follow-up call 140 days after the last
    dose of the study drug. Those who PD will have an Early Termination
    visit, complete the procedures outlined in the protocol preferably
    within 2 weeks of discontinuation. Followed by a call 140 days after the
    last dose of study drug to determine the status of ongoing and new
    AEs/SAEs.
    I soggetti che completano oppure interrompono in maniera anticipata lo studio (PD) saranno trattati secondo il miglior giudizio clinico del medico sperimentatore. Per i soggetti che completano lo studio, è previsto un contatto telefonico di follow-up 140 giorni dopo l’ultima dose del medicinale sperimentale. Coloro che avranno interrotto lo studio in maniera anticipata saranno sottoposti a una visita di Interruzione Anticipata e completeranno le procedure previste dal prot [vedere forum OsSC]
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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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