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    Summary
    EudraCT Number:2017-002465-22
    Sponsor's Protocol Code Number:M16-011
    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:2021-06-17
    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 number2017-002465-22
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
    Studio Clinico di Fase 3, Randomizzato, e in Doppio Cieco per Confrontare Risankizumab Rispetto a Placebo in Soggetti Affetti da Artrite Psoriasica (PsA) in Fase Attiva con Storia di Risposta Inadeguata o Intolleranza ad Almeno un Farmaco Antireumatico Modificante la Malattia (DMARD) (KEEPsAKE 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD)Therapy (KEEPsAKE 1)
    Studio Clinico per Confrontare Risankizumab a Placebo in Soggetti con Artrite Psoriasica (PsA) in Fase Attiva, che hanno una Storia di Risposta Inadeguata oppure Intolleranza ad Almeno un Farmaco Antireumatico Modificante la Malattia (DMARD) (KEEPsAKE 1)
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberM16-011
    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, Vanwell 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 codeABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 IgG monoclonal antibody
    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
    Psoriatic Arthritis
    Artrite Psoriasica
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis is an inflammatory disease where the immune system attacks healthy joints and skin causing pain, swelling, and stiffness in the joints, and red scaly patches on the skin.
    L’artrite psoriasica è una patologia infiammatoria in cui il sistema immunitario attacca articolazioni e cute causando dolore,gonfiore,rigidità delle articolazioni e chiazze rosse squamose della pelle
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis.
    Confrontare l’efficacia di Risankizumab 150 mg rispetto a placebo per il trattamento di segni e sintomi di PsA in pazienti affetti da artrite psoriasica.
    E.2.2Secondary objectives of the trial
    Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis.

    Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1.
    Periodo 1 (in Doppio Cieco): 1. Confrontare l’efficacia di Risankizumab 150 mg rispetto a placebo nell’inibire la progressione del danno strutturale determinata in base a valutazioni radiografiche nella popolazione in studio. 2. Confrontare la sicurezza e la tollerabilità di Risankizumab 150 mg rispetto a placebo in pazienti affetti da artrite psoriasica

    Periodo 2: Valutare la sicurezza, tollerabilità ed efficacia a lungo termine di Risankizumab 150 mg nei soggetti che hanno completato il Periodo 1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
    • Subject has active disease at Baseline
    • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with
    psoriasis at Screening Visit.
    • Presence of either at Screening:
    1. = 1 erosion on radiograph as determined by central imaging review or;
    2. hs-CRP = 3.0 mg/L.
    • Subject has demonstrated an inadequate response to previous or current treatment with at least 1 csDMARD OR subject must have an
    intolerance to or contraindication for csDMARDs as determined by the investigator.
    • Diagnosi clinica di PsA, con esordio dei sintomi almeno 6 mesi prima della visita di screening, e soddisfacimento dei criteri CASPAR (Classification Criteria for PsA) alla visita di Screening.
    • Soggetto con malattia attiva al Baseline
    • Diagnosi di psoriasi a placche in fase attiva, con almeno una placca psoriasica che misura = 2 centimetri (cm) di diametro oppure alterazioni ungueali caratteristiche della psoriasi alla Visita di Screening.
    • Presenza allo Screening di uno fra i due parametri:
    1. = 1 erosione confermata radiograficamente, secondo quanto determinato dalla valutazione del lettore centralizzato oppure;
    2. valore di proteina C reattiva ad alta sensibilità (hsCRP) = 3,0 mg/L
    • Il soggetto deve aver dimostrato una risposta inadeguata al trattamento pregresso oppure in atto con almeno 1 csDMARD OPPURE il soggetto deve essere intollerante oppure presentare controindicazione ai csDMARDs secondo quanto accertato dallo sperimentatore
    E.4Principal exclusion criteria
    • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
    • Subject has a known hypersensitivity to Risankizumab.
    • Subject has previous treatment with biologic agent.
    • Soggetto che il medico sperimentatore considera, per qualsiasi motivo, non idoneo a partecipare allo studio clinico.
    • Soggetto con nota ipersensibilità a Risankizumab
    • Soggetto che ha ricevuto trattamento pregresso con un agente biologico
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 Response (ACR20) at Week 24.
    L’endpoint primario è rappresentato dalla percentuale di soggetti che ottengono la risposta ACR 20 (American College of Rheumatology, ACR) alla Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    1. Change from Baseline in Health Assessment Questionnaire –
    Disability Index (HAQ-DI) at Week 24;
    2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI)
    90 response at Week 24 (in the subset of subjects with a BSA = 3% at
    Baseline);
    3. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at
    Week 24;
    4. Proportion of subjects achieving Minimal Disease Activity (MDA) at
    Week 24;
    5. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F, US)/ modified Nail Psoriasis Severity Index (mNAPSI, ex-US) at Week 24 (in the subset of subjects with nail psoriasis at Baseline); Note:
    PGA-F and mNAPSI assessments will be obtained in all patients
    6. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline;
    7. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline;
    8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24;
    9. Change from Baseline in Functional Assessment of Chronic Illness
    Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.

    Other secondary endpoints without multiplicity adjustment are:
    1. Proportion of subjects achieving ACR50 response at Week 24;
    2. Proportion of subjects achieving ACR70 response at Week 24.
    1. Variazione rispetto al Baseline nel punteggio HAQ-DI (Health Assessment Questionnaire – Disability Index) rilevato alla Settimana 24;
    2. Percentuale di soggetti che ottengono la risposta PASI 90 (Psoriasis Area Severity Index) alla Settimana 24 (nel sottogruppo di soggetti con BSA = 3% al Baseline);
    3. Variazione rispetto al Baseline del punteggio PsA-mTSS (modified Total Sharp Score) alla Settimana 24;
    4. Percentuale di soggetti che ottengono la risposta MDA (Minimal Disease Activity) alla Settimana 24;
    5. Variazione rispetto al Baseline della valutazione PGA-F (FIngernail-Physician Global Assessment, USA) / mNAPSI (Nail Psoriasis Severity6 Index (tutti gli altri paesi) alla Settimana 24 (nel sottogruppo di soggetti con psoriasi ungueale al Baseline); NB: Le valutazioni PGA-F e mNAPSI saranno realizzate in tutti i pazienti, negli Stati Uniti ed in tutti gli altri paesi.
    6. Percentuale di soggetti con risoluzione dell'entesite (LEI = 0) alla 24a settimana nei soggetti con entesite al Baseline;
    7. Percentuale di soggetti con risoluzione della dattilite (LDI = 0) alla Settimana 24 in soggetti con dattilite al Baseline;
    8. Variazione rispetto al Baseline del punteggio del dominio relativo alla componente fisica (PCS, Physical Component Summary) del questionario SF-36 (36-Item Short Form Health Survey) alla Settimana 24
    9. Variazione rispetto al Baseline del punteggio FACIT Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) alla Settimana 24

    Altri endpoint secondari senza regolazione della molteplicità sono:
    1. 2. Percentuale di soggetti che ottengono una risposta ACR50 alla 24a settimana;
    2. 2. Percentuale di soggetti che hanno raggiunto la risposta ACR70 alla 24a settimana.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 EEA144
    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
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Ukraine
    United States
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    Finland
    Germany
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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
    Last protocol contact or last protocol follow-up of the last subject, whichever is longer.
    Ultimo contatto previsto dal protocollo oppure ultimo follow-up previsto dal protocollo dell’ultimo soggetto, quale dei due si verifichi per ultimo
    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 months72
    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 months72
    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: 712
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 490
    F.4.2.2In the whole clinical trial 880
    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)
    Active subjects randomized to Risankizumab: subjects will continue on study treatment throughout the study for a period of up to 1456
    days/208 weeks/4 years or until premature discontinuation of study drug. At the subject's last study visit, the investigator will discuss the
    appropriate subsequent treatment with the subject. Risankizumab may not be commercially available. AbbVie will not provide Risankizumab or any other therapy once the subject's participation is concluded.
    Soggetti attivi randomizzati a Risankizumab:i soggetti continueranno a ricevere il trattamento durante lo studio clinico per un massimo di 1456giorni/208settimane/4anni,oppure fino all’interruzione anticipata del trattamento con il medicinale sperimentale.All’ultima visita,lo sperimentatore discuterà del successivo trattamento appropriato con il soggetto.Risankizumab potrebbe non essere in commercio.AbbVie non fornirà Risankizumab o altra terapia una volta conclusa la partecipazione del soggetto
    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 Decision2019-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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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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