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    Summary
    EudraCT Number:2019-001888-75
    Sponsor's Protocol Code Number:RD.06.SPR.118169
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results View 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 number2019-001888-75
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderateto- Severe Atopic Dermatitis
    Studio randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di nemolizumab (CD14152) in soggetti con dermatite atopica da moderata a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess the efficacy and safety of Nemolizumab (CD14152) compared to placebo in patients with Atopic Dermatitis.
    Studio per valutare l'efficacia e sicurezza di Nemolizumab (CD14152) rispetto al placebo in pazienti con dermatite atopica.
    A.3.2Name or abbreviated title of the trial where available
    RD.06.SPR.118169
    RD.06.SPR.118169
    A.4.1Sponsor's protocol code numberRD.06.SPR.118169
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03989349
    A.5.4Other Identifiers
    Name:IND numberNumber:117122
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/106/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalderma SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma S.A.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressRue entre-deux- Ville 10
    B.5.3.2Town/ cityLa Tour-de-Peilz
    B.5.3.3Post code1814
    B.5.3.4CountrySwitzerland
    B.5.6E-mailCTA.Coordinator@galderma.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 nameCD14152
    D.3.2Product code [CD14152]
    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 INNNEMOLIZUMAB
    D.3.9.1CAS number 1476039-58-3
    D.3.9.2Current sponsor codeCD14152 / CIM331
    D.3.9.3Other descriptive nameHumanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A
    D.3.9.4EV Substance CodeSUB191036
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 placeboPowder and solvent 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
    Atopic Dermatitis
    Dermatite Atopica
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis
    Dermatite Atopica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy and safety of Nemolizumab (CD14152) after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis not adequately controlled with topical treatments.
    L'obiettivo primario è valutare l'efficacia e la sicurezza di nemolizumab (CD14152) dopo un periodo di trattamento di 16 settimane in soggetti adulti e adolescenti con dermatite atopica da moderata a grave non adeguatamente controllata con trattamenti topici.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of maintenance treatment with Nemolizumab (CD14152) for up to an additional 32 weeks.
    L'obiettivo secondario è valutare sicurezza ed efficacia di un trattamento di mantenimento con nemolizumab (CD14152) per un massimo di ulteriori 32 settimane.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: 3.0
    Date: 03/10/2019
    Title: Optional Subject Interviews and Pharmacogenomic testing
    Objectives: Optional Subject Interviews and Pharmacogenomic testing

    Farmacogenomica
    Versione: 3.0
    Data: 03/10/2019
    Titolo: Colloqui facoltativi con soggetto e test farmacogenomici
    Obiettivi: Colloqui facoltativi con soggetto e test farmacogenomici
    E.3Principal inclusion criteria
    1. Male or female subjects aged = 12 years at the screening visit.
    Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study.
    The sponsor will send a written communication to the site confirming that the study is open for enrollment of adolescents. Adolescents must not be enrolled in the study until such communication is received.
    2. Chronic AD for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit.
    3. EASI score = 16 at both the screening and baseline visits.
    4. IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3
    is moderate and 4 is severe) at both the screening and baseline visits.
    5. AD involvement = 10% of body surface area (BSA) at both the screening and baseline visits.
    6. Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit.
    7. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI).
    8. Agree to apply a moisturizer throughout the study from the screening visit; agree to apply authorized topical therapy from the screening visit and throughout the study as determined appropriate by the investigator.
    9. Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
    This criterion also applies to a prepubertal female subject who begins menses during the study.
    10. Female subjects of non-childbearing potential must meet one of the following criteria:
    •Absence of menstrual bleeding for 1 year prior to screening without any other medical reason
    •Documented hysterectomy or bilateral oophorectomy at least 3 months before screening
    11. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the subject using an electronic handheld device provided for this study.
    12. Understand and sign an informed consent form (and assent form, when applicable) before any investigational procedure(s) are performed.
    1. Soggetti di sesso maschile o femminile, di età = 12 anni al momento della visita di screening.
    Nota: l'arruolamento dei soggetti di età compresa fra 12 e 17 anni avrà inizio dopo che un IDMC avrà valutato i dati di sicurezza ad interim dallo studio di fase 2 (Protocollo 116912) e fornito raccomandazioni allo sponsor, che stabilirà l'idoneità di questo gruppo di età per l'arruolamento nello studio. Lo sponsor invierà una comunicazione scritta al centro per confermare che lo studio è aperto all'arruolamento degli adolescenti. I soggetti adolescenti non possono essere arruolati nello studio finché non si riceve tale comunicazione.
    2. AD cronica per almeno 2 anni prima della visita di screening e confermata secondo i criteri di consenso della American Academy of Dermatology (Appendice 1)2.al momento della visita di screening.
    3. Punteggio EASI = 16 sia alla visita di screening che alla visita basale.
    4. Punteggio IGA = 3 (sulla scala IGA da 0 a 4, in cui 3 corrisponde a moderata e 4 a grave) sia alla visita di screening che alla visita basale.
    5. Coinvolgimento AD = 10% dell'area della superficie corporea (BSA) sia alla visita di screening che alla visita basale.
    6. Punteggio del prurito NRS massimo di almeno 4,0 sia alla visita di screening che alla visita basale.
    Il punteggio PP NRS allo screening verrà determinato mediante una singola valutazione PP NRS (punteggio da 0 a 10) per il periodo di 24 ore immediatamente precedente alla visita di screening.
    Il punteggio PP NRS al basale verrà determinato secondo la media dei punteggi PP NRS giornalieri (punteggio da 0 a 10) durante i 7 giorni immediatamente precedenti alla visita basale (non è consentito l'arrotondamento). Per il calcolo sono necessari almeno 4 punteggi giornalieri sui 7 giorni immediatamente precedenti alla visita basale.
    7. Anamnesi recente documentata (entro 6 mesi prima della visita di screening) di risposta inadeguata ai farmaci per uso topico (TCS con o senza TCI).
    8. Accettare di applicare un idratante per la durata dello studio, a partire dalla visita di screening; accettare di applicare la terapia topica autorizzata a partire dalla visita di screening e durante lo studio, come ritenuto appropriato dallo sperimentatore.
    9. I soggetti di sesso femminile in età fertile devono acconsentire a rispettare una assoluta astinenza sessuale durante lo studio e per le 12 settimane successive all'ultima iniezione del farmaco dello studio oppure a utilizzare un metodo contraccettivo efficace e appropriato durante lo studio e per le 12 settimane successive all'ultima iniezione del farmaco dello studio.
    10. I soggetti di sesso femminile non potenzialmente fertili devono soddisfare uno dei criteri seguenti:
    ¿ Assenza di sanguinamento mestruale per 1 anno prima dello screening senza alcun'altra ragione medica
    ¿ Isterectomia o ovariectomia bilaterale documentata almeno 3 mesi prima dello screening
    11. Il soggetto (e il tutore, ove applicabile) devono essere disposti e in grado di rispettare tutti gli impegni in termini di tempo e requisiti procedurali previsti nel protocollo dello studio clinico, comprese le registrazioni giornaliere nel diario da parte del soggetto mediante un dispositivo palmare fornito per lo studio specifico.
    12. Comprensione e firma di un modulo di consenso informato (e di un modulo di assenso, ove applicabile) prima che venga effettuata qualsiasi procedura sperimentale.
    E.4Principal exclusion criteria
    1. Body weight < 30 kg.
    2. Subjects meeting 1 or more of the following criteria at screening or baseline:
    2a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
    2b. Reporting asthma that has not been well-controlled (ie, symptoms occurring on > 2 days per week, nighttime awakenings > 1-3 times per week, or some interference with normal activities) during the preceding 3 months.
    2c. Asthma Control Test = 19 (only for subjects with a history of asthma).
    2d. Peak expiratory flow < 80% of the predicted value.
    3. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
    4. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit. Subjects may be rescreened once the infection has resolved.
    5. Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit.
    6. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit.
    7. Having received any of the treatments specified in Table 3 reported in the protocol within the specified timeframe before the baseline visit.
    8. Previous treatment with Nemolizumab.
    9. Subjects who failed to respond clinically to previous treatment with a biologic (eg, dupilumab) or an oral Janus kinase inhibitor.
    10. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
    11. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 52 weeks before the baseline visit, or (2) actinic keratoses that have been treated and have no evidence of recurrence in the last 12 weeks.
    12. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg,
    monoclonal antibody) or to any of the study drug excipients.
    13. History of intolerance to TCS or for whom TCS is not advisable (eg, hypersensitivity, significant skin atrophy).
    14. Known active or latent tuberculosis infection.
    15. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
    16. History of or current confounding skin condition (eg, Netherton syndrome, psoriasis, cutaneous Tcell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
    17. Any medical or psychological condition or any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (> 3 × upper limit of normal [ULN]) in combination with elevated bilirubin (> 2 × ULN), at the screening visit that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (eg, poor venous access or needle-phobia).
    18. Planned or expected major surgical procedure during the clinical study.
    19. Subjects unwilling to refrain from using prohibited medications during the clinical study.
    20. Currently participating or participated in any other study of a drug or device, within the past 3 months before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
    21. History of alcohol or substance abuse within 2 years of the screening visit.
    1.Peso corp.<30kg.
    2.Il sogg.corrisponde a 1 o più dei seguenti criteri allo screening o al basale:2a.Esacerbaz.di asma che ha richiesto il ricovero osp.nei 12mesi preced. 2b.Asma non ben controllata(ovvero, i sintomi si presentano>2gg a settim., i risvegli notturni>1-3 a settim.oppure la malattia interferisce con le normali attività)nei 3mesi precedenti. 2c.Test di controllo dell'asma= 9(solo per i soggetti con anamnesi di asma). 2d.Picco di flusso espiratorio<80% del valore previsto.
    3.Sogg.con anamnesi medica corrente di patolog.polmonare cronica ostruttiva e/o bronchite cronica.
    4.Infez.cutanea nella settim.precedente alla visita di screening o qualsiasi infez.che ha richiesto il trattam.con antibiotici,antivirali,antiparassitari o antifungini per via orale o parenterale, nella settim.precedente la visita di screening. I sogg.possono essere nuovamente sottoposti a screening una volta risolta l'infezione.
    5.Necessità di terapia di salvataggio per AD durante il periodo di run-in o prevista terapia di salvataggio nelle 2settim.successive alla visita basale.
    6.Risultati positivi per la sierologia(antigene di superficie dell'epatite B [HBsAg] o anticorpo core dell'epatite B [HBcAb], anticorpi dell'epatite C o anticorpo contro il virus dell'immunodeficienza umana)alla visita di screening.
    7.Aver ricevuto uno qualsiasi dei trattamenti seguenti nella Tabella3 nel periodo di trattam.specificato prima della visita basale.
    8.Trattam.preced.con nemolizumab.
    9.Sogg.che non hanno risposto a un trattamento preced.con un agente biologico(ad es.,dupilumab)o con un inibitore della chinasi Janus per via orale.
    10.Donne in gravidanza(test di gravid.nel siero positivo alla visita di screening o test di gravid.nelle urine positivo alla visita basale),donne in allattamento o che pianificano una gravid.durante lo studio.
    11.Anamnesi di malattia linfoproliferativa o neoplasia di qualsiasi sistema e organo negli ultimi 5anni, fatta eccezione per(1)carcinoma basocellulare, carcinoma a cellule squamose in situ(malattia di Bowen)o carcinomi in situ della cervice trattati e senza evidenze di recidiva nelle ultime 52settim.prima della visita basale o (2) cheratosi attinica trattata e senza evidenze di recidiva nelle ultime 12settim.
    12Anamnesi di ipersensibilità(compresa l'anafilassi)a un prod.di immunoglobuline(di derivazione plasmatica o ricombinante,es. un anticorpo monoclonale)o a uno degli eccipienti del farmaco dello studio.
    13.Anamnesi di intolleranza a TCS oppure uso di TCS non consigliabile (ad es.,ipersensibilità, atrofia cutanea significativa).
    14.Infez.tubercolare nota attiva o latente.
    15.Immunosoppress.nota o sospetta o infez.insolitamente frequenti,ricorrenti,gravi o prolungati, in base al giudizio dello sperimentat.
    16.Anamnesi di condiz.cutanea corrente confondente(es. sindrome di Netherton,psoriasi,linfoma cutaneo a cellule T [micosi fungoide o sindrome di Sezary],dermatite da contatto,dermatite attinica cronica,dermatite erpetiforme).
    17.Qualsiasi condizioni medica-psicologica-eventuali anomalie di laboratorio clinicam.rilevanti, come, a es,ALT o AST elevata(>3 × limite superiore della norma [ULN]) in combinazione con bilirubina elevata(>2 × ULN),alla visita di screening che potrebbe esporre il sogg.a un rischio significativo secondo il giudizio dello sperimentat., qualora il sogg.partecipasse allo studio clinico, o potrebbe interferire con le valutazioni dello studio(ad es., accesso venoso inadeguato o fobia degli aghi).
    18.Intervento chirurgico imp.pianificato o previsto durante lo studio.
    19.I sogg.che non desiderano astenersi dall'uso di farmaci non consentiti durante lo studio.
    20.Partecipazione attuale o precedente a qualsiasi altro studio su un farmaco o un dispositivo, negli ultimi 3mesi prima della visita di screening o se deve essere osservato un periodo di esclus. (se verificabile)da uno studio preced.
    21.Anamnesi di abuso di alcol o di sost.nei 2anni della visita di screening.
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary Endpoints:
    • Proportion of subjects with an IGA success (defined as an IGA of 0
    [clear] or 1 [almost clear] and a = 2-point reduction from baseline) at
    Week 16
    • Proportion of subjects with EASI-75 (= 75% improvement in EASI
    from baseline) at Week 16
    Endpoint co-primari:
    - Percentuale di soggetti con successo IGA (definito come un IGA di 0 [assenza di lesioni] o 1 [lesioni quasi assenti] e una riduzione = 2 punti rispetto al basale) alla Settimana 16
    - Percentuale di soggetti con EASI-75 (miglioramento = 75% di EASI rispetto al basale) alla Settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    16 settimane
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    • Proportion of subjects with an improvement of PP NRS = 4 at Week 16
    • Proportion of subjects with PP NRS < 2 at Week 16
    • Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) = 4 at Week 16
    • Proportion of subjects with an improvement of PP NRS = 4 at Week 4
    • Proportion of subjects with PP NRS < 2 at Week 4
    • Proportion of subjects with an improvement of PP NRS = 4 at Week 2
    • Proportion of subjects with an improvement of PP NRS = 4 at Week 1
    • Proportion of subjects with EASI-75 and improvement of PP NRS = 4 at Week 16
    • Proportion of subjects with IGA success and improvement of PP NRS = 4 at Week 16
    ¿ Percentuale di soggetti con un miglioramento PP NRS = 4 alla Settimana 16
    ¿ Percentuale di soggetti con PP NRS < 2 alla Settimana 16
    ¿ Percentuale di soggetti con un miglioramento dei disturbi del sonno NRS (SD NRS) = 4 alla Settimana 16
    ¿ Percentuale di soggetti con un miglioramento PP NRS = 4 alla Settimana 4
    ¿ Percentuale di soggetti con PP NRS < 2 alla Settimana 4
    ¿ Percentuale di soggetti con un miglioramento PP NRS = 4 alla Settimana 2
    ¿ Percentuale di soggetti con un miglioramento PP NRS = 4 alla Settimana 1
    ¿ Percentuale di soggetti con EASI-75 e un miglioramento PP NRS = 4 alla Settimana 16
    ¿ Percentuale di soggetti con successo IGA e un miglioramento PP NRS = 4 alla Settimana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    Come specificato nell'elenco degli End points
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Singapore
    United States
    Belgium
    Bulgaria
    Estonia
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    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 months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 130
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 589
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Enrollment of subjects aged 12-17 will begin only after an IDMC assessment
    L'arruolamento dei soggetti di età compresa fra 12 anni e 17 anni inizierà solo dopo la valutazione
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
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