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    Summary
    EudraCT Number:2020-004300-34
    Sponsor's Protocol Code Number:MLN0002-3024
    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:2021-08-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004300-34
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy
    Studio di fase 3 randomizzato, in doppio cieco volto a valutare l’efficacia e la sicurezza di vedolizumab per via endovenosa come terapia di mantenimento in soggetti pediatrici con colite ulcerosa da moderatamente a gravemente attiva che hanno ottenuto una risposta clinica dopo una terapia endovenosa in aperto con vedolizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis
    Studio per valutare l’efficacia e la sicurezza di vedolizumab in soggetti pediatrici con colite ulcerosa da moderatamente a gravemente attiva
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberMLN0002-3024
    A.5.4Other Identifiers
    Name:INDNumber:009125
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/361/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTAKEDA DEVELOPMENT CENTER AMERICAS INC.
    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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointDirector, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016174441281
    B.5.5Fax number000000
    B.5.6E-mailmark.patti@takeda.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 ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderTAKEDA PHARMA A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom (Northern Ireland)
    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 nameVedolizumab
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameMLN0002
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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
    Moderately to severely active Ulcerative Colitis (UC)
    Colite ulcerosa da moderatamente a gravemente attiva
    E.1.1.1Medical condition in easily understood language
    Moderately to severely active Ulcerative Colitis. UC is a long-term condition that results in inflammation and ulcers of the colon and rectum
    Moderately to severely active Ulcerative Colitis. UC is a long-term condition that results in inflammation and ulcers of the colon and rectum
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 2 different dose regimens of vedolizumab IV in pediatric subjects with moderately to severely active UC during maintenance therapy, based on clinical remission at Week 54.
    valutare l’efficacia di 2 diversi regimi di dosaggio di vedolizumab per via endovenosa in soggetti pediatrici con CU da moderatamente a gravemente attiva durante la terapia di mantenimento, in base alla remissione clinica alla Settimana 54.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of high and low doses of vedolizumab IV as measured by sustained clinical and endoscopic remission at Weeks 14 and 54.
    • To evaluate the effect of high and low doses of vedolizumab IV in each weight group on achieving corticosteroid-free remission at Week 54.
    • To evaluate the effect of vedolizumab IV in each weight group on clinical response and clinical remission over time up to Week 54.
    • To characterize the exposure of 2 different regimens of vedolizumab in pediatric subjects with moderately to severely active UC after IV administration.
    • To evaluate safety in pediatric subjects on maintenance therapy up to Week 54.
    • To evaluate the immunogenicity of vedolizumab in pediatric subjects with moderately to severely active UC treated with vedolizumab IV.
    • To evaluate the effect of vedolizumab on patterns of growth and pubertal development in pediatric subjects with moderately to severely active UC during their participation in the study.
    Fare riferimento alla sinossi in Italiano
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects male or female aged 2 to 17 years, inclusive, who weigh =10 kg at the time of screening and enrollment into the study.
    2. Subjects with moderately to severely active UC diagnosed at least 1 month before screening, defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of =2 (mucosal friability indicates an endoscopic subscore of at least 2).
    3. Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate), and/or TNF-a antagonist therapy (eg, infliximab, adalimumab). This includes subjects who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease when
    attempting to wean off corticosteroids.
    4. Subjects with evidence of UC extending proximal to the rectum (ie, not limited to proctitis), at a minimum.
    5. Subjects with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
    6. Subjects with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.
    Soggetti ambosesso di età compresa tra 2 e 17 anni, inclusi, che pesano =10 kg al momento dello screening e dell’arruolamento nello studio.
    Soggetti con CU da moderatamente a gravemente attiva diagnosticata almeno 1 mese prima dello screening, definita da un punteggio Mayo modificato da 5 a 9 (somma del sottopunteggio Mayo endoscopico, sottopunteggio di frequenza delle evacuazioni e sottopunteggio di sanguinamento rettale) con un sottopunteggio endoscopico Mayo =2 (la friabilità mucosale indica un sottopunteggio endoscopico di almeno 2).
    Soggetti che non hanno risposto, hanno perso la risposta o sono risultati intolleranti al trattamento con almeno 1 dei seguenti agenti: corticosteroidi, immunomodulatori (per es. azatioprina, 6-mercaptopurina, metotrexato) e/o terapia con antagonisti del TNF-a (per es. infliximab, adalimumab). Ciò include i soggetti che sono dipendenti dai corticosteroidi per il controllo dei sintomi e che manifestano un peggioramento della malattia quando tentano di sospendere i corticosteroidi.
    Soggetti con evidenza di CU che, come minimo, si estende prossimalmente fino al retto (ovvero, non limitata alla proctite).
    I soggetti con colite estensiva o pancolite di durata >8 anni o colite al lato sinistro di durata >12 anni devono presentare evidenza documentata di una colonscopia di sorveglianza negativa entro 12 mesi prima dello screening.
    Soggetti con vaccinazioni che risultano aggiornate in base al programma vaccinale dell’infanzia accettato a livello nazionale.
    E.4Principal exclusion criteria
    1. Subjects who have had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 antagonists or rituximab.
    2. Subjects who have had prior exposure to vedolizumab.
    3. Subjects with hypersensitivity or allergies to any of the vedolizumab excipients.
    4. Subjects who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
    5. Subjects with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
    6. Subjects who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
    7. Subjects who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
    8. Subjects with a current diagnosis of indeterminate colitis.
    9. Subjects with clinical features suggesting monogenic very early onset inflammatory bowel disease.
    Soggetti che hanno avuto una precedente esposizione ad anti-integrine approvate o sperimentali, tra cui, a titolo esemplificativo ma non esaustivo, natalizumab, efalizumab, etrolizumab o AMG 181, o antagonisti della molecola di adesione cellulare addressina mucosale 1 o rituximab.
    Soggetti che sono stati precedentemente esposti a vedolizumab.
    Soggetti con ipersensibilità o allergie a uno qualsiasi degli eccipienti di vedolizumab.
    Soggetti che hanno ricevuto (1) un farmaco biologico sperimentale (diverso da quelli elencati nel Criterio di esclusione n. 1) entro 60 giorni o 5 emivite prima dello screening (a seconda di quale periodo sia più lungo); o (2) un agente biologico o biosimilare approvato nelle 2 settimane che precedono la prima dose del farmaco dello studio o in qualsiasi momento durante il periodo di screening.
    Soggetti con malattia cerebrale/meningea attiva, segni/sintomi o anamnesi di leucoencefalopatia multifocale progressiva (LMP) o eventuali altri disturbi neurologici maggiori, tra cui ictus, sclerosi multipla, tumore cerebrale o malattia neurodegenerativa.
    Soggetti con necessità attuale o prevista di ricorrere a un intervento chirurgico per la CU durante questo studio.
    Soggetti che si sono sottoposti a colectomia subtotale o totale, si sottopongono a digiunostomia, ileostomia, colostomia o sono portatori di tasca ileo-anale o stenosi fissa nota dell’intestino.
    Soggetti con diagnosi attuale di colite indeterminata.
    Soggetti con caratteristiche cliniche che suggeriscono la presenza di una malattia infiammatoria intestinale monogenica a insorgenza molto precoce.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical remission at Week 54, where clinical remission based on the modified Mayo score is defined as:
    • stool frequency subscore 0 to 1 and a decrease of 1 or more from baseline;
    • rectal bleeding subscore of 0;
    • endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability).
    L’endpoint primario è la remissione clinica alla Settimana 54, dove la remissione clinica basata sul punteggio Mayo modificato è definita come:
    • sottopunteggio di frequenza delle evacuazioni da 0 a 1 e una diminuzione di 1 o più rispetto al basale;
    • sottopunteggio di sanguinamento rettale pari a 0; e
    • sottopunteggio endoscopico da 0 a 1 (modificato in modo tale che un punteggio pari a 1 non includa la friabilità).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of study is defined as the Week 54 study visit.
    The end of study is defined as the Week 54 study visit.
    E.5.2Secondary end point(s)
    • Clinical remission at Week 14, where a subject achieves clinical remission if he or she meets the definition described in the primary endpoint.
    • Sustained clinical remission at Week 54, where a subject achieves sustained clinical remission if he or she achieved clinical remission (as defined by primary endpoint) at Week 14 and at Week 54.
    • Corticosteroid-free clinical remission at Week 54, where a subject achieves corticosteroid-free clinical remission at Week 54 if he or she meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to Week 54.
    • Clinical remission based on complete Mayo score at Week 54, where a subject achieves clinical remission if he or she achieved a complete Mayo score =2 points with no individual subscore >1 at Week 54.
    • Clinical remission based on PUCAI score at Week 54, where a subject achieves clinical remission if he or she has a PUCAI of =10 at Week 54.
    • Serum trough concentrations of vedolizumab over time.
    • Positive antivedolizumab antibodies (AVA) and positive neutralizing AVA during the study.
    • Sustained clinical response of subjects at Weeks 14 and 54, where a subject meets clinical response if he or she has a reduction in complete Mayo score (see Appendix G) of =3 points and =30% from baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point.
    • Clinical response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 where a subject achieves clinical response if he or she meets the following definition:
    • Maintenance of a reduction of =2 points and =25% from the baseline partial Mayo score, including a =1-point decrease in the Mayo stool frequency subscore and a =1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of =1 point; and a =20point decrease from baseline in the PUCAI score for Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54.
    • Safety assessments: descriptions of adverse events (AEs); serious adverse events (SAEs); and adverse events of special interest (AESIs), including evaluation of opportunistic infection, such as PML, liver injury, malignancies, infusion-related reactions, and hypersensitivity.
    • Change from baseline in weight gain and linear growth z-score during the course of dosing with vedolizumab.
    • Tanner Stage V at Week 54, where a subject achieves Tanner Stage V at Week 54 based on progression of pubertal changes from baseline.
    • Remissione clinica alla Settimana 14, dove un soggetto raggiunge la remissione clinica se soddisfa la definizione descritta nell’endpoint primario.
    • Remissione clinica sostenuta alla Settimana 54, dove un soggetto raggiunge la remissione clinica sostenuta se ha raggiunto la remissione clinica (come definito dall’endpoint primario) alla Settimana 14 e alla Settimana 54.
    • Remissione clinica libera da corticosteroidi alla Settimana 54, dove un soggetto raggiunge la remissione clinica libera da corticosteroidi alla Settimana 54 se soddisfa la definizione descritta nell’endpoint primario e non ha assunto corticosteroidi per almeno 12 settimane prima della Settimana 54.
    • Remissione clinica basata sul punteggio Mayo completo alla Settimana 54, dove un soggetto raggiunge la remissione clinica se ha raggiunto un punteggio Mayo completo =2 punti senza alcun sottopunteggio individuale >1 alla Settimana 54.
    • Remissione clinica basata sul punteggio PUCAI alla Settimana 54, dove un soggetto raggiunge la remissione clinica se presenta un PUCAI =10 alla Settimana 54.
    • Concentrazioni sieriche di valle di vedolizumab nel tempo.
    • Anticorpi anti-vedolizumab (Anti-Vedolizumab Antibody, [AVA]) positivi e AVA neutralizzanti positivi durante lo studio.
    • Risposta clinica sostenuta dei soggetti alle Settimane 14 e 54, dove un soggetto soddisfa la risposta clinica se presenta una riduzione del punteggio Mayo completo (vedere Appendice G) =3 punti e =30% rispetto al basale con una concomitante diminuzione del sottopunteggio di sanguinamento rettale =1 punto o sottopunteggio di sanguinamento rettale assoluto =1 punto.
    • Risposta clinica alle Settimane 2, 6, 10, 14, 22, 30, 38, 46 e 54, dove un soggetto raggiunge la risposta clinica se soddisfa la seguente definizione:
    Mantenimento di una riduzione =2 punti e =25% rispetto al punteggio Mayo parziale al basale, che comprende una riduzione =1 punto nel sottopunteggio Mayo di frequenza delle evacuazioni e una riduzione =1 punto nel sottopunteggio di sanguinamento rettale o sottopunteggio di sanguinamento rettale assoluto =1 punto; e una riduzione =20 punti rispetto al basale nel punteggio PUCAI per le Settimane 2, 6, 10, 14, 22, 30, 38, 46 e 54.
    • Valutazioni di sicurezza: descrizioni di eventi avversi (EA), eventi avversi seri (Serious Adverse Event, [SAE]) ed eventi avversi di particolare interesse (Adverse Event of Special Interest, [AESI]), compresa la valutazione delle infezioni opportunistiche, come LMP, lesione epatica, neoplasie maligne, reazioni correlate all’infusione e ipersensibilità.
    • Variazione rispetto al basale nell’aumento di peso e nel punteggio z della crescita lineare nel corso della somministrazione di vedolizumab.
    • Stadio V di Tanner alla Settimana 54, dove un soggetto raggiunge lo Stadio V di Tanner alla Settimana 54 in base alla progressione delle variazioni puberali rispetto al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSVS
    LVLS
    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 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
    Immunogenicity
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different doses of IMP are used in treatment arms
    Different doses of IMP are used in treatment arms
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Austria
    Belgium
    Bosnia and Herzegovina
    Canada
    China
    Croatia
    Czechia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Lithuania
    New Zealand
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United Kingdom
    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
    The end of study is defined as the Week 54 study visit.
    The end of study is defined as the Week 54 study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days17
    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: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-08-30. Yes
    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
    Children & adolescents (2-17)
    Bambini e adolescenti (2-17 anni)
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pediatric patients
    Pazienti pediatrici
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    Follow-up safety visit 18 weeks after the last dose of study drug and a final LTFU safety survey phone call every 6 months for 2 years after the last dose of study drug for all subjects who do not continue into the extension study and for subjects who discontinue study drug at any time during the study.
    Follow-up safety visit 18 weeks after the last dose of study drug and a final LTFU safety survey phone call every 6 months for 2 years after the last dose of study drug for all subjects who do not continue into the extension study and for subjects who discontinue study drug at any time during the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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