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    Summary
    EudraCT Number:2020-004061-39
    Sponsor's Protocol Code Number:CNTO1959PSO4015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-12
    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 number2020-004061-39
    A.3Full title of the trial
    A Phase 4, Interventional, Single-arm, Open-label Study Evaluating the Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis
    Studio di fase 4, interventistico, a braccio singolo, in aperto volto a valutare l’effetto di guselkumab sui marcatori surrogati del rischio cardiovascolare nei partecipanti con psoriasi a placche da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Patients With Moderate to Severe Plaque Psoriasis
    Effetto di guselkumab sui marcatori surrogati del rischio cardiovascolare nei partecipanti con psoriasi a placche da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    G-CARE
    ----
    A.4.1Sponsor's protocol code numberCNTO1959PSO4015
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International IRL
    B.5.2Functional name of contact point------
    B.5.3 Address:
    B.5.3.1Street Address----------------
    B.5.3.2Town/ city----------------
    B.5.3.3Post code---------------
    B.5.3.4CountryIreland
    B.5.4Telephone number0000000000
    B.5.5Fax number00000000
    B.5.6E-mailclinicaltrial.enquiries@parexel.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.2.5The 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 nameadenosina
    D.3.2Product code [-------]
    D.3.4Pharmaceutical form 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 INNadenosina
    D.3.9.2Current sponsor code-----
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 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 nameGuselkumab
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB179789
    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 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    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
    Psoriasi a placche
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasi
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 effect of guselkumab on CFR measured by transthoracic dopplerechocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk
    Valutare l’effetto di guselkumab sulla riserva di flusso coronarico (CFR) misurata con ecocardiografia doppler transtoracica nei partecipanti con psoriasi da moderata a grave e rischio cardiovascolare intermedio
    E.2.2Secondary objectives of the trial
    - To evaluate the short-term effect of guselkumab on CFR measured by transthoracic dopplere-chocardiography, in participants with moderateto- severe psoriasis and intermediate cardiovascular risk.
    -To evaluate the effect of guselkumab on GLS as a surrogate marker of left ventricular function in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk.
    - To evaluate the effect of guselkumab on arterial stiffness in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk.
    - To evaluate the effect of guselkumab on CFR among participants in the different CFR categories.
    - To evaluate the effect of guselkumab on surrogate CV risk markers among nicotine users and non-users in the participant population.
    - To assess the safety and tolerability of guselkumab in participants with moderate-to severe plaque psoriasis and intermediate cardiovascular risk
    - Valutare l’effetto a breve termine di guselkumab sulla CFR misurata con ecocardiografia doppler transtoracica nei partecipanti con psoriasi da moderata a grave e rischio cardiovascolare intermedio.
    - Valutare l’effetto di guselkumab sullo strain globale longitudinale (GLS) come marcatore surrogato della funzione ventricolare sinistra nei partecipanti con psoriasi da moderata a grave e rischio cardiovascolare
    -Valutare l’effetto di guselkumab sulla rigidità arteriosa nei partecipanti con psoriasi da moderata a grave e rischio cardiovascolare intermedio.
    -Valutare l’effetto di guselkumab sulla CFR tra i partecipanti nelle diverse categorie di CFR.
    - Valutare l’effetto di guselkumab sui marcatori surrogati di rischio CV tra consumatori e non consumatori di nicotina nella popolazione dei partecipanti
    - Valutare la sicurezza e la tollerabilità di guselkumab nei partecipanti con psoriasi a placche da moderata a grave e rischio cardiovascolare intermedio..
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Is male or female 18 years of age and above.
    - Has a diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to the first dose of guselkumab at Week 0. Moderate-tosevere plaque psoriasis is defined as PASI >=12, IGA >=3 and involved BSA
    >=10% at Screening Visit S1. Participants with a predominantly non plaque form of psoriasis will not be eligible for inclusion in the study.
    -Has intermediate cardiovascular risk defined by CFR >=2 to <=3.5.
    - Is a candidate for systemic treatment for psoriasis.
    - Does not have any abnormalities in physical examination, medical history, clinical laboratory tests, vital signs, and 12-lead ECG performed at screening that are not consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator. The 12-lead ECG
    must be assessed by the dermatologist at Screening Visit S1.
    - Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol.
    - È maschio o femmina di età pari o superiore a 18 anni.
    - Ha una diagnosi di psoriasi a placche da moderata a grave per almeno 6 mesi prima della prima dose di guselkumab alla settimana 0. La psoriasi a placche da moderata a grave è definita come PASI > =12, IGA > =3 e BSA coinvolta > =10% alla visita di screening S1. I partecipanti con una forma prevalentemente non a placche di psoriasi non saranno eleggibili per l'inclusione nello studio.
    -Ha un rischio cardiovascolare intermedio definito da CFR da > =2 a <=3,5.
    - È un candidato per il trattamento sistemico della psoriasi.
    - Non presenta anomalie nell'esame obiettivo, nell'anamnesi, nei test clinici di laboratorio, nei segni vitali e nell'ECG a 12 derivazioni eseguito allo screening che non sono coerenti con la malattia sottostante nella popolazione in studio. Questa determinazione deve essere registrata nei documenti clinici del partecipante e siglata dallo sperimentatore. L'ECG a 12 derivazioni deve essere valutato dal dermatologo alla visita di screening S1.
    - Deve firmare un modulo di consenso informato (ICF) indicando che comprende lo scopo e le procedure richieste per lo studio ed è disposto a partecipare allo studio.
    Per la panoramica completa dei criteri di inclusione, fare riferimento alla sezione 5.1 del protocollo.
    E.4Principal exclusion criteria
    - Has low-density lipoprotein >160 mg/dL.
    - Has uncontrolled hypertension that needs immediate medication
    - Has any clinically significant evidence of cardiac functional or valvular abnormalities, other than intermediate cardiovascular risk defined by CFR > = 2 and <=3.5, including but not limited to: coronary stenosis, history of any MI or transient ischemic attacks, stroke, cerebrovascular disease, peripheral atherosclerosis, congestive heart failure, chronic pulmonary disease, fast atrial fibrillation, supraventricular arrhythmia, valvular
    abnormalities, ventricular wall movement abnormalities observed during the CFR assessment
    - Has any contraindications to adenosine infusion, including but not limited to asthma with ongoing wheezing, hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease, greater than first degree heart block without a pacemaker or sick sinus syndrome, systolic blood pressure <90 mmHg and severe sinus
    bradycardia, or other contraindications listed in the SmPC.
    - Unable or unwilling to abstain from caffeine-or nicotine-containing products including but not limited to smoking, vaping, chewing tobacco, nicotine gum and patches for 12
    hours prior to the cardiology assessments.
    - Has diabetes or has HbA1c >6.5.
    For the complete overview of the inclusion criteria, please refer to
    section 5.2 of the protocol.
    - Ha lipoproteine a bassa densità> 160 mg / dL.
    - Ha ipertensione incontrollata che necessita di cure immediate
    - Ha qualsiasi evidenza clinicamente significativa di funzionalità cardiaca o valvolare anomalie, diverse dal rischio cardiovascolare intermedio definito da CFR > =2 e <=3,5, inclusi ma non limitati a: stenosi coronarica, anamnesi di qualsiasi IM o attacchi ischemici transitori, ictus, malattie cerebrovascolari, aterosclerosi periferica, insufficienza cardiaca congestizia, polmonare cronica malattia, fibrillazione atriale rapida, aritmia sopraventricolare, valvolare anomalie, anomalie del movimento della parete ventricolare osservate durante la valutazione CFR
    - Ha controindicazioni all'infusione di adenosina, incluso ma non limitato all'asma con respiro sibilante in corso, ipersensibilità all'adenosina, malattia polmonare broncocostrittiva o broncospastica nota o sospetta, blocco cardiaco maggiore del primo grado senza pacemaker o seno malato sindrome, pressione sanguigna sistolica <90 mmHg e seno grave bradicardia o altre controindicazioni elencate nell'RCP.
    - Incapace o riluttante ad astenersi dal consumo di caffeina o nicotina prodotti inclusi ma non limitati a fumo, svapo, tabacco da masticare, gomme alla nicotina e cerotti per 12 ore prima delle valutazioni cardiologiche. –
    Ha il diabete o ha HbA1c> 6.5.
    Per la panoramica completa dei criteri di inclusione, fare riferimento a sezione 5.2 del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in CFR
    Variazione rispetto al basale nella CFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 32
    Settimana 32
    E.5.2Secondary end point(s)
    - Change from baseline in CFR at Week 16
    - Change from baseline in GLS at Week 32 and change from baseline in GLS at Week 16
    - Change from baseline in cfPWV at Week 32 and change from baseline in cfPWV at Week 16.
    - Change from baseline in CFR at Week 16 and Week 32 among participants with CFR in the ranges of 2 to 2.49, 2.5 to 3, and 3.01 to 3.5 at baseline
    - Change from baseline in CFR at Week 16 and Week 32 among nicotine users and non-users.
    - Change from baseline in GLS at Week 16 and Week 32 among nicotine users and non-users.
    - Change from baseline in cfPWV at Week 16 and Week 32 in nicotine users and non-users
    - Rate of AEs among participants treated with guselkumab.
    - Variazione rispetto al basale nella CFR alla Settimana 16
    - Variazione rispetto al basale nel GLS alla Settimana 32e variazione rispetto al basale nel GLS alla Settimana 16
    - Variazione rispetto al basale nella velocità dell’onda di polso carotideo-femorale (cfPWV) alla Settimana 32 e variazione rispetto al basale nel cfPWV alla settimana 16
    - Variazione rispetto al basale nella CFR alla Settimana 16 e alla Settimana 32 tra i partecipanti con CFR negli intervalli da 2 a 2,49, da 2,5 a 3 e da 3,01 a 3,5 al basale.
    - Variazione rispetto al basale nella CFR alla Settimana 16 e alla Settimana 32 tra consumatori e non consumatori di nicotina.
    - Variazione rispetto al basale nel GLS alla Settimana 16 e alla Settimana 32 tra consumatori e non consumatori di nicotina.
    - Variazione rispetto al basale nella cfPWV alla Settimana 16 e alla Settimana 32 tra consumatori e non consumatori di nicotina.
    - Tasso di EA tra i partecipanti trattati con guselkumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 and 32
    Settimana 16 e 32
    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 Yes
    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
    Biomarker
    Biomarcatori
    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 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
    Studio in Aperto
    Open study
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LVLS
    LVLS
    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 months6
    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 months0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 50
    F.4.2.2In the whole clinical trial 50
    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)
    None
    Nessuno
    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 Decision2021-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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