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    Summary
    EudraCT Number:2018-000681-10
    Sponsor's Protocol Code Number:I1F-MC-RHCG
    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:2021-05-24
    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 number2018-000681-10
    A.3Full title of the trial
    Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
    Studio multicentrico, in aperto, per la valutazione dell'efficacia, della sicurezza, della tollerabilità e della farmacocinetica di Ixekizumab (somministrato per via sottocutanea) con braccio di trattamento Adalimumab come riferimento, in pazienti pediatrici affetti da artrite idiopatica giovanile, nei sottotipi di artrite associata ad entesite (incluso spondilite anchilosante ad esordio giovanile) e artrite psoriasica giovanile.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis
    Un studio dell'Ixekizumab con braccio di trattamento Adalimumab come riferimento in bambini e giovani adulti affetti da artrite idiopatica giovanile, nei sottotipi di artrite associata ad entesite(incluso spondilite anchilosante ad esordio giovanile) e artrite psoriasica giovanile.
    A.3.2Name or abbreviated title of the trial where available
    TALZ
    TALZ
    A.4.1Sponsor's protocol code numberI1F-MC-RHCG
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/280/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number0000000000
    B.5.5Fax number0000000000
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Taltz (80 mg solution for injection in pre-filled syringe)
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND B.V.
    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 nameIxekizumab
    D.3.2Product code [TALTZ]
    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 INNixekizumab
    D.3.9.2Current sponsor codeLY243921
    D.3.9.4EV Substance CodeSUB176389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 2
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameHumira
    D.3.2Product code [L04AB04]
    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 INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeHUMIRA
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
    Sottotipi di artrite associata ad entesite, ERA (incluso spondilite anchilosante ad esordio giovanile SpA-ERA) e artrite psoriasica giovanile, JPsA

    artrite idiopatica giovanile (Juvenile Idiopathic Arthritis) = AIG (JIA)
    sottotipi di artrite associata ad entesite (Subtypes of Enthesitis-related Arthritis) = ERA
    artrite psoriasica giovanile (Juvenile Psoriatic Arthritis) = JPsA
    spondilite anchilosante ad esordio giovanile (Juvenile-Onset Ankylosing Spondylitis) = SpA-ERA
    E.1.1.1Medical condition in easily understood language
    Childhood Arthritis
    Artrite giovanile
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    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 of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the JIA American College of Rheumatology (ACR) 30 response
    Valutare l’efficacia di ixekizumab nei bambini affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG, sulla base della risposta ACR 30 (American College of Rheumatology) per AIG
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the other clinical responses, disease activity and physical function measures
    2. To evaluate the efficacy of adalimumab (reference arm) in children with JIA subtypes of ERA (including JoAS) and JPsA based on JIA ACR 30 and the other clinical responses, disease activity and physical function measures
    3. To characterize ixekizumab pharmacokinetics (PK) in children with JIA subtypes of ERA (including JoAS) and JPsA
    4. To evaluate the potential development of antiixekizumab antibodies and their impact on the efficacy and safety of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA
    5. Describe the safety of ixekizumab in patients with JIA subtypes of ERA (including JoAS) and JPsA
    1. Valutare l’efficacia di ixekizumab nei bambini affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG, sulla base di altre risposte cliniche, dell’attività di malattia e delle misure di funzionalità fisica
    2. Valutare l’efficacia di adalimumab (braccio di riferimento) nei bambini affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG, sulla base della risposta ACR 30 per AIG e delle altre risposte cliniche, dell’attività di malattia e delle misure di funzionalità fisica
    3. Caratterizzare la farmacocinetica (PK) di ixekizumab nei bambini affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG
    4. Valutare il potenziale sviluppo di anticorpi anti-ixekizumab e il loro impatto
    sull’efficacia e sulla sicurezza di ixekizumab nei bambini affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG
    5. Descrivere la sicurezza di ixekizumab nei pazienti affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
    Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
    Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator
    I partecipanti devono soffrire di artrite idiopatica giovanile artrite associata a entesite o artrite psoriasica giovanile)
    I partecipanti devono pesare almeno 10 chilogrammi (kg), avere un’età dai 2 anni se affetti da artrite psoriasica giovanile e dai 6 anni se affetti da artrite associata a entesite
    I partecipanti devono aver ricevuto tutte le vaccinazioni previste dalle attuali linee guida sull’immunizzazione, a giudizio dello sperimentatore
    E.4Principal exclusion criteria
    Participants must not have active or history of inflammatory bowel disease
    Participants must not have active uveitis
    Participants must not have active or latent tuberculosis
    Participants must not have an active infection
    Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis
    I partecipanti non devono avere un’anamnesi di malattia infiammatoria intestinale o soffrire di malattia infiammatoria intestinale in fase attiva
    I partecipanti non devono soffrire di uveite in fase attiva
    I partecipanti non devono soffrire di tubercolosi in fase attiva o latente
    I partecipanti non devono avere un’infezione in atto
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients meeting the JIA ACR 30 response criteria at Week 16
    Percentuale di pazienti che rientrano nei criteri della risposta stabilita dall'ACR 30 (American College of Rheumatology) per AIG alla settimana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    - Percentage of patients meeting the JIA ACR 30/50/70/90/100 response criteria
    - Changes from baseline in each of the 6 individual components of the JIA ACR core set variables
    - Change from baseline in Psoriasis Area and Severity Index (PASI) for JPsA patients with at least 3% Body Surface Area (BSA) at baseline
    - Change from baseline in Leeds Enthesitis Index (LEI) for patients with enthesitis at baseline
    - Proportion of patients with disease flare (flare defined as worsening of =30% from baseline in at
    least 3 of the 6 JIA ACR core set criteria and an improvement of =30% in no more than 1 of the
    criteria)
    - Trough concentrations of ixekizumab in patients with JIA subtypes of ERA (including JoAS) and JPsA at Week 16
    - Percentage of patients with anti-ixekizumab antibodies
    - Adverse events (AEs) including serious adverse
    events (SAEs)
    - Safety parameters including but not limited to infections, injection site reactions, and laboratory
    data including B-, T-cell, and natural killer (NK)- cell levels, white blood cell (WBC) count, red
    blood cell (RBC) count, alanine aminotransferase (ALT), aspartate aminotransferase (AST)
    - Percentuale di pazienti che soddisfano i criteri della risposta ACR 30/50/70/90/100 per AIG
    -Variazione rispetto al basale di ognuna delle 6 singole variabili fondamentali che compongono la risposta ACR per AIG
    -Variazione rispetto al basale dell’indice PASI (Psoriasis Area and Severity Index) per i pazienti affetti da APsG con un coinvolgimento della superficie corporea (BSA) di almeno il 3% al basale
    -Variazione rispetto al basale dell’indice LEI (Leeds Enthesitis Index) per i pazienti con entesite al basale
    -Percentuale di pazienti con una riacutizzazione della malattia (dove con “riacutizzazione” si intende un peggioramento =30%, rispetto al basale, di almeno 3 dei 6 criteri fondamentali della risposta ACR per AIG e un miglioramento =30% di non più di 1 criterio)
    -Concentrazione minima di ixekizumab nei pazienti affetti dai sottotipi di AIG ERA (inclusa JoAS) e APsG alla settimana 16
    -Percentuale di pazienti con anticorpi anti-ixekizumab
    -Eventi avversi (AE) inclusi gli eventi avversi seri (SAE)
    -Parametri di sicurezza inclusi, in via non esaustiva, infezioni, reazioni nel sito di iniezione e dati di laboratorio tra cui livelli di linfociti B, T e natural killer (NK), numero di globuli bianchi, numero di globuli rossi, alanina aminotransferasi (ALT), aspartato aminotransferasi (AST).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes will be assessed at each regular study visit (every 3 months)
    Gli outcome secondari saranno valutati in occasione di ciascuna visita regolare prevista dallo studio (ogni 3 mesi)
    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 Yes
    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
    Tolerability
    Tollerabilità
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    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
    Patients 2-18 years old
    pazienti dai 2 ai 18 anni di età
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    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)
    Patients who complete the OLT and OLE periods of this study may be eligible to participate in an open-label LTE study (Study RHCY) if enrollment criteria for the LTE are met.
    I pazienti che completano i periodi OLT e OLE dello studio potranno essere eleggibili per la partecipazione allo studio di estensione in aperto a lungo termine (LTE) (studio RHCY), nel caso in cui vengano soddisfatti i criteri di arruolamento per la LTE
    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 Decision2020-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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