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    Summary
    EudraCT Number:2017-003053-42
    Sponsor's Protocol Code Number:CNTO1959PSO3011
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 ConcernedNetherlands - Competent Authority
    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 Subjects (≥6 To <18 Years of Age)
    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 Subjects
    A.3.2Name or abbreviated title of the trial where available
    PROTOSTAR
    A.4.1Sponsor's protocol code numberCNTO1959PSO3011
    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 N.V.
    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 Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 5242166
    B.5.5Fax number+31 71 5242110
    B.5.6E-mailClinicalTrialsEU@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 Yes
    D.2.1.1.1Trade name TREMFYA™
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    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 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.3.8INN - Proposed INNGuselkumab
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO 1959
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 typeMonoclonal antibody
    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 Yes
    D.2.1.1.1Trade name TREMFYA™
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    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 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.3.8INN - Proposed INNGuselkumab
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO 1959
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 typeMonoclonal antibody
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.4EV Substance CodeSUB01984MIG
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 in pre-filled syringe
    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 and solution 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
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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.
    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.
    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
    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-TNFα biologic therapy within the previous 3 months before the first administration of study intervention.
    12. Is not a suitable candidate for anti-TNFα 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-TNFα 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
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2. Week 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.
    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
    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
    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 No
    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
    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
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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.1.1Number of subjects for this age range: 100
    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)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 100
    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 treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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