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    Summary
    EudraCT Number:2017-003053-42
    Sponsor's Protocol Code Number:CNTO1959PSO3011
    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:2021-06-14
    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 number2017-003053-42
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants(=6 To <18 Years of Age)
    Uno studio di fase 3 multicentrico, randomizzato, controllato con placebo e confronto attivo per valutare l’efficacia, la sicurezza e la farmacocinetica di guselkumab somministrato per via sottocutanea per il trattamento della psoriasi a placche cronica in partecipanti pediatrici (da =6 a <18 anni di età)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Guselkumab in the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
    uno studio per valutare efficacia, sicurezza e farmacocinetica di Guselkumab nel trattamento della psoriasi a placche cronica in partecipanti pediatrici
    A.3.2Name or abbreviated title of the trial where available
    PROTOSTAR
    PROTOSTAR
    A.4.1Sponsor's protocol code numberCNTO1959PSO3011
    A.5.4Other Identifiers
    Name:N/ANumber:N/A
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/129/2018
    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 CILAG SpA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJANSSEN CILAG INTERNATIONAL NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG INTERNATIONAL NV
    B.5.2Functional name of contact pointCLINICAL REGISTRY GROUP
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 19
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailstart-up-janssen-italy@its.jnj.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 nameGuselkumab
    D.3.2Product code [CNTO1959]
    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 INNGuselkumab
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    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 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 typeanticorpo monoclonale
    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
    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 INNGuselkumab
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    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 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: 3
    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.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEnbrel (Etanercept)
    D.3.2Product code [Not Applicable]
    D.3.4Pharmaceutical form Powder and solvent for 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 INNETANERCEPT
    D.3.9.1CAS number 185223-69-0
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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.IMP: 4
    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.2.1.1.1Trade name ENBREL
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEnbrel (Etanercept)
    D.3.2Product code Not Applicable
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution 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
    Chronic Plaque Psoriasis
    Psoriasi cronica a placche
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasi
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    - To evaluate the efficacy and safety of guselkumab in pediatric participants aged =6 through <18 years with chronic plaque psoriasis.
    valutare sicurezza ed efficacia di guselkumab in pazienti pediatrici di età compresa tra 6 e 18 anni con psoriasi cronica a placche
    E.2.2Secondary objectives of the trial
    - To evaluate the PK and immunogenicity of guselkumab in pediatric participants aged =6 through <18 years with chronic plaque psoriasis.
    - To evaluate the effect of guselkumab on the dermatologic health-related quality of life in pediatric participants aged =6 through <18 years with chronic plaque psoriasis.
    - To evaluate maintenance of response in participants who have active treatment withdrawn.
    - To evaluate the efficacy and safety of retreatment with guselkumab.
    - To generate clinical usability data and use experience with the VarioJect presentation (PFS-V) in pediatric participants with chronic plaque psoriasis and a body weight <70 kg.
    Per valutare il PK e l'immunogenicità di guselkumab in pazienti pediatrici di età compresa tra = 6 e <18 anni con psoriasi a placche cronica.
    - Valutare l'effetto del guselkumab sulla qualità della vita dermatologica correlata alla salute nei partecipanti pediatrici di età = 6 a <18 anni con psoriasi a placche cronica.
    - Valutare il mantenimento della risposta nei partecipanti che hanno sospeso il trattamento attivo.
    - Valutare l'efficacia e la sicurezza del ritrattamento con guselkumab.
    - Generare dati sull'uso clinico e utilizzare l'esperienza con la presentazione di VarioJect (PFS-V) nei partecipanti pediatrici con psoriasi a placche cronica e un peso corporeo <70 kg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be a boy or girl =6 to <18 years of age.
    2. Have a diagnosis of chronic plaque-type psoriasis for at least 6 months , prior to first administration of study intervention, defined as having at screening and baseline:
    • Investigator’s Global Assessment (IGA) =3 and
    • Psoriasis Area and Severity Index (PASI) =12 and
    • =10% Body Surface Area (BSA) involvement and
    at least one of the following:
    - very thick lesions or
    - clinically relevant facial, genital, or hand/ foot involvement or
    - PASI =20 or
    - >20% BSA involvement or
    - IGA=4
    3. Be a candidate for phototherapy or systemic treatment of plaque psoriasis
    4. Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy.
    5. Be considered, in the opinion of the investigator, a suitable candidate for etanercept (ENBREL) therapy according to their country's approved ENBREL product labeling.
    6. Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
    7. Contraceptive use by boys or girls should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.
    Before randomization, a girl must be either:
    a. Not of childbearing potential defined as:
    - premenarchal. A premenarchal state is one in which menarche has not yet occurred.
    - permanently sterile Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
    - or otherwise be incapable of pregnancy.
    b. Of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after last dose - the end of relevant systemic exposure.
    8. A girl must agree not to donate eggs for the purposes of assisted reproduction during the study and for a period of at least 12 weeks following the last dose of study intervention.
    9. A girl of childbearing potential must have a negative urine pregnancy test at screening and at all visits when study intervention is to be administered.
    10. A boy who is sexually active with a female of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control or a partner with an occlusive cap, during the study and for at least 12 weeks after receiving the last administration of study intervention. All boys must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention.
    11. Are considered eligible according to the following TB screening criteria:
    • Have no history of latent or active TB before screening.
    • Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    • Have had no recent close contact with a person with active TB.
    • Within 10 weeks before the first administration of study intervention, have a negative QuantiFERON®-TB Gold test result. Within 10 weeks before the first administration of study intervention, a negative tuberculin skin test is additionally required if the QuantiFERON-TB Gold test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities.

    Please refer to pages 34-38 of the protocol or the complete overview of the inclusion criteria
    1. i partecipanti devono essere ragazzi o ragazze di età compresa tra i 6 e i 18 anni

    2. devono avere una diagnosi di psoriasi tipica a placche da almeno 6 mesi prima della prima somministrazione del farmaco in studio, definita come segue (allo screening o al basale):
    • Investigator’s Global Assessment (IGA) =3
    • Psoriasis Area and Severity Index (PASI) =12
    • =10% della superficie corporea (BSA) coinvolta
    e almeno con uno dei seguenti:
    - lesione molto spessa
    - coinvolgimento rilevante del viso, dei genitali o di mani e piedi
    - PASI =20
    - >20% del coinvolgimento BSA
    - IGA=4

    3. essere candidati per fototerapia o trattamento sistemico della psoriasi a placche

    4. avere una psoriari a placche che sia considerata dallo sperimentatore come non controllata adeguatamente con fototerapia e/o terapia topica dopo una dose e una durata adeguate della terapia

    5. essere considerato, secondo lo sperimentatore, un candidato adatto per terapia con etanercept (ENBREL) in accordo con le indicazioni di ENBREL approvate nel Paese;

    6. essere in buona salute sulla base di esame fisico, storia medica e valutazione dei segni vitali effettuati allo screening. qualsiasi anormalità deve essere consistente con la malattia della popolazione in studio e qualsiasi evidenza deve essere indicata nei source documents del partecipante, siglati dallo sperimentatore;

    7. l'uso di contraccettivi di ragazzi e ragazze deve essere consistente con la normativa locale vigente in merito all'uso dei contraccettivi nei partecipanti ai trial clinici;

    prima della randomizzazione una ragazza deve essere:
    a: non potenzialmente fertile, definito come:
    -premenarca - prima delle prime mestruazioni
    - permanentemente sterile (isterectomia, salpingectomia bilaterale, occlusione delle tube bilaterale o legatura bilaterale delle tube; ooforectomia bilaterale;
    - altrimenti nell'impossibilità di restare gravida.

    b. potenzialmente fertile e praticante un metodo di contraccezione altamente efficace e disposta a mantenerlo durante la sperimentazione e fino a 12 settimane dopo l'ultima dose (ovvero la fine della esposizione sistemica rilevante)

    8. una ragazza deve affermare di non voler donare ovuli al fine della fecondazione assistita durante la sperimentazione e fino a 12 settimane dopo l'ultima dose

    9. una ragazza in età potenzialmente fertile deve avere un test di rgravidanza su urine negativo allo screening e a tutte le visite quando il farmaco in studio sta per essere somministrato;

    10. un ragazzo sessualmente attivo con una partner potenzialmente fertile e che non ha subito una vasectomia deve usare un metodo a barriera per il controllo delle nascite, o avere una partner con un cappuccio occlusivo, durante lo studio e per almeno 12 settimane dopo l'ultima somministraizone di farmaco in studio;

    11. sono considerati eleggibili in accordo ai seguenti criteri di screening di tubercolosi:
    -non avere storia di tubercolosi latente o attiva prima dello screening;
    -non avere segni o sintomi che possano suggerire -tubercolosi, sia con storia clinical che con esame fisico;
    -non deve aver avuto contatti con persone con tubercolosi attiva;
    -nelle 10 settimane precedenti la prima somministrazione del farmaco in studio deve avere un test QuantiFERON negativo. Entro le 10 settimane prima della prima somministrazione del farmaco in studio è richiesto un test tubercolino su pelle aggiuntivo, nel caso in cui il quantiFERON non sia autorizzato nel Paese o il test sia obbligatorio in base alla normativa vigente

    (per un elenco completo dei criteri di inclusione si prega di fare riferimento alle pagine da 34 a 38 del protocollo)
    E.4Principal exclusion criteria
    Medical history-related exclusion criteria:
    1. Currently has nonplaque forms of psoriasis
    2. Has current drug-induced psoriasis
    3. Is pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study intervention.
    4. Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
    5. Has a transplanted organ
    6. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study.
    7. Has unstable suicidal ideation or suicidal behavior:
    • Participants =12 to <18 years of age may not be randomized if they have:
    - a Columbia-Suicide Severity Rating Scale rating at screening of: suicidal ideation with intention to act suicidal ideation with specific plan and intent or non-suicidal self-injurious behavior within the past 6 months, OR
    - a C-SSRS rating at screening of suicidal behavior
    • Participants =6 to <12 years of age may not be randomized if they have:
    - a C-SSRS rating at screening of: suicidal ideation with intention to act suicidal ideation with specific plan and intent r suicidal behavior or any self-injurious behavior ever
    • Participants with a C-SSRS rating at screening of Wish to be Dead (“Ideation level 1”), Non-Specific Active Suicidal Thoughts or Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act may not be randomized if:
    - participants =12 to <18 years of age have one of the above C-SSRS ratings within the past 6 months and are determined to be at risk by the investigator after being discussed with the medical monitor or designee.
    - participants =6 to <12 years of age have one of the above C-SSRS ratings ever (lifetime) and are determined to be at risk by the investigator after being discussed with the medical monitor or designee.
    8. Is known to have had a substance abuse problem within the previous 12 months.

    Medical therapies-related exclusion criteria:
    9. Has previously received guselkumab or etanercept.
    10. Has any contraindications to the use of etanercept per local prescribing information.
    11. Has received any anti-TNFa biologic therapy within the previous 3 months before the first administration of study intervention.
    12. Is not a suitable candidate for anti-TNFa therapy for the following reasons:
    • Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis.
    • Has known or suspected intolerance or hypersensitivity to anti-TNFa medications (eg, clinical lupus-like syndrome, serum sickness-like reaction).
    • Has a history of, or concurrent congestive heart failure (CHF), including medically controlled CHF.
    13. Has received any therapeutic agent directly targeted to IL-12/23, IL-17, or IL-23 within 6 months of the first administration of study intervention (including but not limited to ustekinumab, tildrakizumab, secukinumab, ixekizumab, risankizumab, or brodalumab).
    14. Has received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.

    Please refer to pages 38-42 of the protocol for the complete overview of the exclusion criteria
    Criteri di esclusione correlati con la storia clinica

    1. Attualmente ha forme di psoriasi non a placche

    2. Ha una psoriasi indotta da farmaci

    3. È incinta, allatta o sta pianificando una gravidanza o un figlio durante la sua partecipazione allo studio o entro 12 settimane dopo aver ricevuto l'ultima somministrazione di farmaco in studio.

    4. Ha una storia o segni o sintomi attuali di patologia grave, progressiva o non sotto controllo di tipo renale, epatico, ematologico, gastrointestinale, endocrino, polmonare, cardiaco, neurologico, cerebrale o psichiatrico.

    5. Ha un organo trapiantato

    6. Ha avuto un intervento chirurgico maggiore entro 8 settimane prima dello screening, o non si è completamente ristabilito da da tale intervento chirurgico, o ha pianificato un tale intervento chirurgico durante il lasso di tempo per cui è previsto che il partecipante partecipi allo studio.

    7. Ha ideazione suicidaria instabile o comportamento suicidario:
    • I partecipanti di età compresa tra 12 e <18 anni non possono essere randomizzati se hanno:
    - una valutazione della gravità del grado di gravità della Columbia-Suicide allo screening di:
    ideazione suicida con intenzione di agire;
    ideazione suicida con piano specifico e intento; comportamento autolesionistico non suicida negli ultimi 6 mesi,
    oppure
    - un punteggio C-SSRS allo screening del comportamento suicidario

    • I partecipanti di età compresa tra =6 e <12 anni non possono essere randomizzati se hanno:
    - un punteggio C allo screening SSRS di:
    ideazione suicidaria con intenzione di agire
    ideazione suicidaria con piano specifico e intenzione; comportamento suicidario o altro comportamento autolesionistico
    • Partecipanti con un punteggio C-SSRS allo screening "Wish to be Dead" ("Ideazione di livello 1"), Pensieri suicidi attivi non specifici o Ideazione suicidaria attiva con qualsiasi metodo (ma senza piano) e senza intenzione di agire non possono essere randomizzati se:
    - se partecipanti da 12 anni a 18 anni, hanno avuto uno dei rating C-SSRS precedentemente menzionati negli ultimi 6 mesi e lo sperimentatore li definisce a rischio suicidio dopo aver discusso con il monitor o suo designato.
    - se partecipanti da 6 a 12 anni, hanno mai avuto nel corso della vita uno dei precedentirating C-SSRS e lo sperimentatore li definisce a rischio suicidio dopo aver discusso con il monitor o suo designato.

    8. È noto che abbia avuto un problema di abuso di sostanze nei 12 mesi antecedenti

    Criteri di esclusione correlati alle terapie mediche:

    9. Ha già ricevuto guselkumab o etanercept.

    10. Ha controindicazioni all'uso di etanercept secondo le informazioni di prescrizioni locali;

    11. Ha ricevuto una terapia biologica anti-TNFa nei 3 mesi precedenti alla prima somministrazione del farmaco in studio;

    12. Non è un candidato adatto per la terapia anti-TNFa per uno qualsiasi dei seguenti motivi:
    • Ha una storia di malattie demielinizzanti note, come sclerosi multipla o neurite ottica.
    • Ha intolleranza o ipersensibilità nota o sospetta ai farmaci anti-TNFa (es. sindrome da lupus clinico, SSLR, ecc).
    • Ha o ha avuto un'insufficienza cardiaca congestizia concomitante (CHF), anche se sotto controllo medico.

    13. Ha ricevuto agenti terapeutici direttamente mirati all'IL-12/23, IL- 17 o IL-23 entro 6 mesi dalla prima somministrazione del farmaco in studio (quali a titolo esemplificativo ustekinumab, tildrakizumab, secukinumab, ixekizumab, risankizumab o brodalumab).

    14. Ha ricevuto natalizumab, efalizumab o agenti che riducono le cellule B o T entro i 12 mesi precedenti allo screening o se, dopo aver ricevuto questi agenti,
    sono disponibili allo screening delle evidenze cliniche che indicano il persistere di diminuzione della popolazione dei linfociti

    Si prega di fare riferimento alle pagine 38-42 del protocollo per la panoramica completa di i criteri di esclusione
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints include: 1. The proportion of participants achieving an IGA score of cleared (0) or minimal (1) at Week 16. 2. The proportion of participants with a PASI 75 response at Week 16.
    Gli endpint co primari includono:

    1. la proporzione di partecipanti che ottengono un punteggio IGA 0 o 1 alla sedicesima settimana

    2. la proporzione di partecipanti con risposta al PASI di 75 alla settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2 week 16
    1, 2 settimana 16
    E.5.2Secondary end point(s)
    - Major Secondary Endpoints for Part 1 of the study:
    1. The proportion of participants achieving a PASI 90 response at Week
    16.
    2. The proportion of participants achieving an IGA score of cleared (0) at
    Week 16.
    3. The change from baseline in CDLQI at Week 16.
    4. The proportion of participants achieving a PASI 100 response at Week
    16.
    Other Secondary Endpoints for Part 1 of the study include:
    5. The proportion of retreated participants that achieve a PASI 90
    response over time after retreatment.
    6. The proportion of retreated participants that achieve PASI responses
    (PASI 50, 75, 90, and 100) or IGA responses (IGA of cleared [0],
    minimal [1], or mild [2], IGA of cleared [0] or minimal [1], and IGA of
    cleared [0]) over time after retreatment.
    7. The time to loss of 50% of the Week 16 PASI improvement (ie, time to
    retreatment) after withdrawal.
    8. The time to loss of PASI 90 response after withdrawal.
    9. The proportion of participants achieving a PASI 50 response at Week
    16.
    10. The proportion of participants who achieve an IGA score of mild or
    better (=2) at Week 16.
    11. The percent improvement from baseline in PASI over time through
    Week 16.
    12. The proportion of PASI responses (PASI 50, 75, 90, and 100) over
    time through Week 16.
    13. The proportion of IGA responses (IGA of cleared [0], minimal [1], or
    mild [2], IGA of cleared [0] or minimal [1], and IGA of cleared [0]) over
    time through Week 16.
    14. The proportion of participants with CDLQI=0 or 1 at Week 16 among
    randomized participants with a baseline CDLQI>1.
    15. The proportion of participants with Family Dermatology Life Quality
    Index (FDLQI)=0 or 1 at Week 16 among randomized participants with a
    baseline FDLQI>1.
    16. The change from baseline in FDLQI at Week 16.
    Secondary Endpoints for Part 2 of the study:
    PASI responses, IGA responses, PASI percent improvement, change
    from baseline in CDLQI and FDLQI, the proportion of participants
    achieving a CDLQI of 0 or 1, and the proportion of participants achieving
    a FDLQI of 0 or 1 will be summarized over time through Week 52.
    18. In addition, efficacy in the long-term extension (LTE) period for
    participants who continue in the LTE of the study will be summarized.
    endpoint secondari maggiori per la Parte1:
    1. la proporzione di partecipanti che raggiunge una risposta PASI di 90 alla settimana 16

    2. la proporzione di partecipanti che raggiunge un punteggio di 0 IGA

    3. il cambio nel CDLQI dal basale alla settimana 16

    4. 1. la proporzione di partecipanti che raggiunge una risposta PASI di 100 alla settimana 16

    altri endpoint secondari per la parte 1 includono:
    5. 1. la proporzione di partecipanti ritirati che raggiunge un punteggio PASI di 90 dopo il trattamento

    6. 1. la proporzione di partecipanti ritirati che raggiunge differenti punteggi PASI (50,75, 90 e 100) o una risposta IGA (0 - pulito, 1 - minimo o 2-moderato; 0 - pulito, 1 - minimo; 0 - pulito) dopo il trattamento;

    7. il tempo in cui si perde il 50% del beneficio al punteggio PASI dato dal farmaco alla settimana 16 dopo il ritiro dallo studio;

    8. l tempo in cui si perde il punteggio PASI 90 dopo il ritiro dallo studio

    9. la proporione di partecipanti che raggiunge un punteggio PASI pari a 50 dopo 16 settimane

    10. la proporzione di pazienti che raggiunge un punteggio IGA di moderato o migliore dopo la settimana 16

    11. il miglioramento percentuale dal basale in termini di PASI nel corso del tempo fino alla settimana 16

    12. le proporzioni di risposte PASI (50,75,90 e 100) nel corso del tempo fino alla settimana 16

    13. la proporzione di risposte IGA (0 - pulito, 1 - minimo o 2-moderato; 0 - pulito, 1 - minimo; 0 - pulito) nel corso del tempo fino alla settimana 16

    14. la proporzione dei partecipanti con CDLQI=0 o 1 alla settimana 16 tra i pazienti randomizzati con un CDLQI>1 al basale

    15. la proporzione di partecipanti con FDLQI=0 o 1 alla settimana 16 tra i pazienti randomizzati con un FDLQI>1 al basale

    16. il cambiamento nel FDLQI dal basale alla settimana 16

    endpoint secondari della parte 2 dello studio:
    risposte PASI, risposte IGA, miglioramento percentuale del PASI, cambiamento dal basale in CDLQI e FDLQI, la proporzione di partecipanti che raggiunge un lputeggio CDLQI di 0 o 1 e la proporzione di parteicpanti che raggiungono un FDLQI di 0 o 1, fino alla settimana 52.

    18. in più, verrà riassunta l'efficacia nel periodo di estenzione LTE per il partecipanti che continuano in LTE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3,4. At Week 16

    5,6,7,8. At Week 52

    9,10. At Week 16

    11,12,13. At Week 0,4,8,12 and 16

    14,15. At Week 16

    16. At Baseline and at week 16

    17. For PASI and IGA responses: At week 20,24,28,32,36,40,44,48 and 52;
    For CDLQI and FDLQI: At baseline and at week 28,36,48,52;

    18. Week 60 Through Study Completion/Termination
    1,2,3,4 settimana 16

    5,6,7,8, settimana 52
    9,10 settimana 16
    11,12,13, a settimana 0,4,8,12 e 16
    14,15 a settimana 16
    16al basale e a settimana 16
    17
    per PASI e IGA: alle settimane 20,24,28,32,36,40,44,48 e 52
    per CDLQI e FDLQI: al basale e alle settimane 28,36,48,52

    18. dalla settimana 60 fino alla fine dello studio
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Analyses
    analisi di immunogenicità
    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 Yes
    E.8.1.7.1Other trial design description
    nella Parte 1, la randomizzazione nel braccio guselkumab/placebo sarà in doppio cieco
    In Part 1 of the study, treatment for participants randomized to guselkumab or placebo will be blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Enbrel
    Enbrel
    E.8.2.4Number of treatment arms in the trial3
    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 EEA27
    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
    Belgium
    Brazil
    Canada
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    United States
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study includes Pediatric Subjects (=6 To <18 Years of Age)
    lo studio include pazienti pediatrici di età compresa tra i 6 e i 18 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 125
    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)
    Standard of care
    Standard of care
    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 Decision2018-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-10
    P. End of Trial
    P.End of Trial StatusOngoing
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