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    Summary
    EudraCT Number:2019-001889-15
    Sponsor's Protocol Code Number:RD.06.SPR.118163
    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:2020-10-21
    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 number2019-001889-15
    A.3Full title of the trial
    A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis
    Studio a lungo termine, prospettico, multicentrico, 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
    Long-term study to assess the safety and efficacy of Nemolizumab in subjects with Atopic Dermatitis
    Studio a lungo termine per valutare la sicurezza e l'efficacia di Nemolizumab in soggetti con dermatite atopica
    A.3.2Name or abbreviated title of the trial where available
    RD.06.SPR.118163
    RD.06.SPR.118163
    A.4.1Sponsor's protocol code numberRD.06.SPR.118163
    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 supportGalderma S.A.
    B.4.2CountrySwitzerland
    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 long-term safety of Nemolizumab
    (CD14152) in adult and adolescent subjects with moderate-to-severe
    atopic dermatitis (AD).
    L'obiettivo primario è valutare la sicurezza a lungo termine di nemolizumab (CD14152) in soggetti adulti e adolescenti con dermatite atopica (AD) da moderata a grave.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the long-term efficacy of
    Nemolizumab (CD14152) in adult and adolescent subjects with
    moderate-to-severe AD
    L'obiettivo secondario è valutare l'efficacia a lungo termine di nemolizumab (CD14152) in soggetti adulti e adolescenti con dermatite atopica (AD) da moderata a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for
    AD including:
    a. Subjects who completed the initial treatment period (Week 16 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169) and do not qualifyfor the maintenance period;
    OR
    b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169);
    OR
    c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 vaccination safety study (SPR.118380);
    OR
    d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 adolescent PK/safety study (SPR.116912);
    OR
    e. Subjects who completed the treatment period (Week 24 visit) in the Phase 2b dose-ranging study (SPR.114322) and remain insufficiently controlled on topical therapy alone;
    OR
    f. Subjects who discontinued study medication in a prior study and completed required study visits prior to LTE participation (Week 16 visit for SPR.118161 and SPR.118169 initial treatment period, Week 32 visit
    for SPR.118161 and SPR.118169 maintenance period; final study visits for SPR.118380 [Week 16], SPR.116912 [Week 16], and SPR.114322 [Week 24]), unless the subject experienced an AE that may present an unreasonable risk if study medication is continued;
    Note(s): For ongoing studies, transfer into the LTE study should occur as soon as possible to minimize gaps in study medication dosing.Subjects who enroll within 28 days of completing the final visit of a lead-in study may use final
    study assessments for the screening visit, unless the subject prematurely discontinued study drug in the lead-in study. All other subjects should complete a separate screening visit within 28 days before the first dose of study medication in the LTE.
    2. Agree to apply a moisturizer at least once daily throughout the study and agree to apply the authorized topical therapy, as determined appropriate by the investigator;
    3. Women 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.
    Effective and approved methods of contraception applicable for the subject and/or her partner are defined below:
    • Progestogen-only oral hormonal contraception;
    • Male or female condom;
    • Cap, diaphragm, or sponge with spermicide;
    • Combination of male or female condom with cap, diaphragm, or sponge with spermicide;
    • Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception;
    • Injectable or implanted hormonal contraception;
    • Intrauterine devices;
    • Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study;
    • Vasectomy of partner at least 3 months before the study.
    4. 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.
    5. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol;
    6. Understand and sign an informed consent form (and assent form, when applicable), before any investigational procedure(s) being performed.
    1.Sogg.che potrebbero beneficiare della partecipaz.allo studio secondo il parere dello speriment.e che hanno partecipato a uno studio preced.su nemolizumab per l'AD,compresi:
    a.Sogg.che hanno completato il periodo di trattam.iniziale(visita della Sett.16) in uno studio cardine di fase3(SPR.118161 o SPR.118169)e non sono risultati idonei per il periodo di mantenim.;
    O
    b.Sogg.che hanno completato il periodo di mantenim.(visita dellaSett.48)in uno studio cardine di fase3(SPR.118161oSPR.118169);
    O
    c.Sogg.che hanno completato il periodo di trattam.(visitadellaSett.16)nello studio di sicurezza della vaccinazione di fase2(SPR.118380);
    O
    d.Sogg.che hanno completato il periodo di trattam.(visita dellaSett.16)nello studio PK/di sicurezza su adolescenti di fase2(SPR.116912);
    O
    e.Sogg.che hanno completato il periodo di trattam.(visita dellaSett.24)nello studio dose-ranging di fase2b(SPR.114322)e non ottengono un controllo suff.con la sola terapia topica;
    O
    f.Sogg.che hanno interrotto la terapia dello studio in uno studio preced.e completato le visite dello studio richieste prima della partecipaz.all'LTE(visita dellaSett.16per il periodo di trattam.iniziale di SPR.118161eSPR.118169,visita dellaSett.32 per il periodo di manutenzione di SPR.118161e SPR.118169;visita dello studio finale perSPR.118380[Sett.16],SPR.116912[Sett.16]e SPR.114322[Sett.24]),a meno che il sogg.non abbia manifestato un evento avverso(AE)che potrebbe presentare un rischio irragionevole in caso di prosecuzione della terapia con il farmaco dello studio.
    Note:per gli studi in corso,il passaggio allo studio LTE deve avvenire il prima possibile per ridurre al minimo il gap nella somministraz.del farmaco dello studio.I sogg.che vengono arruolati entro 28gg.dal completam.della visita finale di uno studio di provenienza possono utilizzare le valutaz.finali dello studio per la visita di screening,a meno che il sogg.non abbia interrotto prematuramente il farmaco dello studio di provenienza.Tutti gli altri sogg.devono completare una visita di screening separata entro 28gg prima della prima dose del farmaco dello studio nell'LTE.
    2.I sogg.devono acconsentire di applicare un idratante almeno una volta al gg nel corso dello studio e di applicare la terapia topica autorizzata durante lo studio, come definito appropriato dallo speriment.
    3.Le donne in età fertile devono acconsentire a rispettare un'assoluta astinenza sess.durante lo studio e per le12sett.success.all'ultima iniezione del farmaco dello studio o a utilizzare un metodo contraccettivo efficace e idoneo durante lo studio e per le12sett.success.all'ultima iniezione del farmaco dello studio.Questo criterio si applica anche a ragazze in età prepuberale che hanno le prime mestruazioni durante lo studio.
    I metodi contraccettivi efficaci e idonei per il sogg.e il/la suo(a) partner sono:
    •Contraccez.ormonale esclusivam.a base di progestinici
    •Preservativo masch.o femm.
    •Cappuccio,diaframma o spugna con spermicida
    •Combinaz.di preservativo masch.o femm.con cappuccio,diaframma o spugna con spermicida
    •Contraccez.ormonale combinata(estrogeni e progestinici)orale,intravaginale o transdermica
    •Contraccez.ormonale iniettabile o impiantata
    •Dispositivi intrauterini
    •Legatura bilaterale delle tube o inserto nelle tube(come il sistema Essure)almeno3mesi prima dello studio
    •Vasectomia del partner almeno3mesi prima dello studio
    4.I sogg.di sesso femm.non potenzialmente fertili devono soddisfare uno dei criteri seguenti:
    •Assenza di sanguinamento mestruale per1anno prima dello screening senza altra ragione medica
    •Isterectomia o ovariectomia bilaterale documentata almeno3mesi prima dello screening
    5.Il sogg.(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.
    6.Comprensione e firma di un modulo di consenso informato(e modulo di assenso,ove applicab.) prima che venga effettuata qualsiasi procedura speriment.
    E.4Principal exclusion criteria
    1.Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an
    unreasonable risk for the subject;
    2.Having received any of the treatments listed in Table 6 of the protocol within the specified timeframe before the baseline visit;
    3.Pregnant women,breastfeeding women, or women planning a pregnancy during the clinical study;
    4.Any medical or psychological condition 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;
    5.Planning or expected to have a major surgical procedure during the clinical study;
    6.Subjects unwilling to refrain from using prohibited medications during
    the clinical study;
    Additional Exclusion Criteria: For subjects who do not rollover from a prior nemolizumab study within 28 days of completing final study assessments or who discontinued study drug before completing the
    treatment period during the lead-in study:
    7.Body weight <30kg;
    8.Subjects with a history of asthma meeting 1 or more of the following criteria:
    8a.Had an asthma exacerbation requiring hospitalization in the preceding 12 months;
    8b.Reporting asthma that has been not well controlled (ie,symptoms>2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the preceding 3 months;
    8c. Asthma Control Test(ACT)=19;
    8d. Peak expiratory flow<80%of the predicted value.
    9.Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.;
    10.Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1week before the
    screening visit. Subjects may be rescreened once the infection has resolved;
    11.Positive serology results(hepatitisB surface antigen or hepatitisB core antibody,hepatitisC antibody,or human immunodeficiency virus antibody)at the screening visit;
    12.Subjects who failed to respond clinically to previous treatment with a biologic(eg, dupilumab)or a Janus kinase inhibitor;
    13.History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for basal cell carcinoma,squamous cell carcinoma in situ (Bowen's disease),actinic keratoses,or carcinoma in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit;
    14.History of hypersensitivity(including anaphylaxis)to an immunoglobulin product or to any of the study drug excipients;
    15.History of intolerance to TCS or for whom TCS is not advisable(eg,hypersensitivity to TCS,significant skin atrophy,etc),unless TCS was not used as background therapy in the lead-in study;
    16.Known active or latent tuberculosis infection;
    17.Known or suspected immunosuppression or unusually frequent,recurrent,severe,or prolonged infections as per investigator judgment;
    18.History of or current confounding skin condition (eg,Netherton Syndrome,psoriasis,cutaneous T-cell lymphoma,contact dermatitis,chronic actinic dermatitis,dermatitis herpetiformis);
    19.Any clinically relevant lab.abnormalities, such as but not limited to elevated ALT or AST(>3× upper limit of normal) in combination with elevated bilirubin(>2× upper limit of normal),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;
    20.Currently participating or participated in any other study of a drug or device within the past 2 months before the screening visit, or is in an exclusion period(if verifiable)from a previous study, other than the
    nemolizumab for AD studies;
    21.History of alcohol or substance abuse within 2 years of the screening visit.
    1.Sogg.che,dur.la partecip.in uno studio preced.su nemolizumab,hanno riscontrato AE che,2o lo speriment.potrebbe indicare un rischio non ragionev.per il sogg.se proseguisse il trattam.con nemolizumab.2.Aver ricevuto uno dei trattam.elencati in Tabella26 del protoc.nel periodo di trattam.specific.prima della visita basale.3.Donne in gravid.,in allattam.o che pianific.una gravid.durante lo studio.4.Ogni condiz.medica-psicolog.alla visita di screen.che potrebbe esporre il sogg.a un rischio significat.2o il giudizio dello speriment.,qualora il sogg.partecipasse allo studio,o potrebbe interferire con le valutaz.dello studio.5.Interv.chirurgico imp.pianificato o prev.nello lo studio.6.I sogg.che non vogliono astenersi dall'uso di farmaci non consentiti durante lo studio(vedi Sezione8.4.9.2).Criteri di esclus.aggiunt.:per i sogg.che non effettuano il passagg.da uno studio preced.su nemolizumab entro28ggdal completam.delle valutaz.finali dello studio o che hanno interrotto la terapia con il farmaco dello studio prima di completare il periodo di trattam.durante lo studio di provenienza.7.Peso corp<30kg.8.Sogg.con anamnesi di asma e che corrisponde a1o più dei seguenti criteri:8a.Esacerbaz.di asma che ha richiesto il ricovero osp.nei12mesi preced;8b.Asma non ben controllata(ossia,sint.si pres.>2gg a sett.,risvegli nott.>1-3 a sett.o la malattia interferisce con le normali attiv.)nei3mesi preced; 8c.Test controllo asma(ACT,AsthmaControlTest)=19;8d.Picco di flusso espiratorio<80%del valore prev.9.Sogg.con anamnesi med.corrente di patolog.polmon.cronica ostruttiva e/o bronchitecronica.10.Infez.cutan.nella sett.preced.alla visita di screen.o qualsiasi infez.che ha richiesto il trattam.con antibiotici,antivirali,antiparassit.o antifungini per via orale o parenterale,nella sett.preced.la visita di screening.I sogg.possono essere nuovam.sottop.a screening una volta risolta l'infez.11.Risultati+per la sierolog.(antigene di superfic.dell'epatiteB o antic.core dell'epatiteB,antic.dell'epatiteC o antic.contro il virus dell'immunodefic.umana)alla visita di screening. Nota:i sogg.+all'antic.core dell'epatiteB e negativi all'antig.di superf.dell'epatiteB poss.essere inclusi in questo studio se+per l'antic.di superf.dell'epatiteB(consider.immuni dopo infez.nat).12.Sogg.che non hanno risp.a un trattam.preced.con un agente biolog.(es.,dupilumab)o con un inibit.della chinasiJanus.13.Anamnesi di malatt.linfoproliferat.o neoplasia di qualsiasi sist.e organo negli ultimi 5anni,a eccez.di carcinoma basocellulare,carcinoma a cellule squamose in situ(malattia di Bowen),cheratosi attinica o carcinoma in situ della cervice trattato e senza evidenze di recidiva nelle 12sett.prima della visita di screen.14.Anamnesi di ipersensib.(anche anafilassi)a un prod.di immunoglob.o a uno qualsiasi degli eccipienti del farmaco dello studio.
    15.Anamnesi di intoller.a TCS oppure uso di TCS non consigliab.(es,ipersensib.aTCS,atrofia cutanea significat.etc),a meno che iTCS non siano stati utilizz.come terap.di base nello studio di riferim.16.Infez.tubercolare nota attiva o latente.17.Immunosoppr.nota o sosp.o infezin.solitam.frequ.,ricorrenti,gravi o prolungati,2o giudizio dello sperimentat.
    18.Anamnesi di condiz.cutanea corrente che può risultare confond.(es.sindr.di Netherton,psoriasi,linfoma cutaneo a celluleT,dermat.da contatto,dermat.attinica cronica,dermat.erpetiforme).19.Ogni anomalia di lab.clinicam.rilev.,come es.,ALToAST elevata(>3×limite sup.della norma)in combinaz.con bilirub.elev.(>2×limite sup.della norma),alla visita di screen.che potrebbe esporre il sogg.a un rischio significat.2o il giudizio dello sperimentat,qualora il sogg.partecipasse allo studio.20.Partecipaz.attuale o preced.ad altro studio su farmaco o disposit.,negli ultimi 3mesi prima della visita di screen.o se deve essere osservato un periodo di esclus.(se verificab.)da uno studio preced.diverso dagli studi su nemolizumab nell'AD.21.Anamnesi di abuso di alcol o sostanze nei2anni della visita di screen.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    - Incidence and severity of treatment-emergent AEs throughout the
    study
    - Incidence of serious treatment-emergent AEs throughout the study
    - Incidence and severity of AEs of special interest (AESIs)
    Endpoint di sicurezza:
    • Incidenza e gravità degli eventi avversi emergenti dal trattamento durante lo studio
    • Incidenza di eventi avversi gravi emergenti dal trattamento durante lo studio
    • Incidenza e gravità di eventi avversi (AE) di interesse specifico (AESI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety Endpoints: throughout the study
    Endpoint di sicurezza: durata dello studio
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    - Proportion of subjects with IGA score = 0-1 at each visit through Week 112
    - Proportion of subjects with EASI-75 response at each visit through Week 112
    - Change and percent change from baseline in EASI at each visit through Week 112
    - Proportion of subjects with low disease activity state (ie, IGA = 2) at each visit through Week 112
    - Change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score at each visit through Week 112
    - Change and percent change from baseline in subject-reported pruritus using 10-cm visual analogue scale (SCORAD sub-component)
    - Change and percent change from baseline in subject-reported sleep loss using 10-cm visual analogue scale (SCORAD sub-component)
    - Proportion of subjects reporting low disease activity state (clear, almost clear, or mild) based on Patient Global Assessment of Disease 5- point scale at each visit up to Week 112
    - Proportion of subjects satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment 5-point Likert scale at each visit up to Week 112
    - Proportion of subjects receiving any concomitant AD treatment by treatment type (eg, topical, phototherapy, systemic) throughout the treatment period
    - Proportion of subjects receiving any rescue therapy by rescue treatment type at any visit during the treatment period.
    Endpoint di efficacia:
    • Percentuale di soggetti con punteggio IGA = 0-1 in ciascuna visita fino alla Settimana 112
    • Percentuale di soggetti con risposta EASI 75 in ciascuna visita fino alla Settimana 112
    • Variazione (assoluta e percentuale) dal basale per EASI in ciascuna visita fino alla Settimana 112
    • Percentuale di soggetti con basso stato di attività della malattia (ovvero IGA = 2) in ciascuna visita fino alla Settimana 112
    • Variazione (assoluta e percentuale) dal basale del punteggio SCORAD (SCORing Atopic Dermatitis, punteggio per la dermatite atopica) in ciascuna visita fino alla Settimana 112
    • Variazione (assoluta e percentuale) dal basale nel punteggio del prurito riportato dal soggetto nella scala visiva analogica da 10 cm (sotto-componente SCORAD)
    • Variazione (assoluta e percentuale) dal basale nel punteggio della perdita di sonno riportato dal soggetto nella scala visiva analogica da 10 cm (sotto-componente SCORAD)
    • Percentuale di soggetti che riportano una bassa attività della malattia (nessuna lesione, lesioni quasi assenti o lievi) nella scala a 5 punti Patient Global Assessment of Disease (valutazione globale della malattia da parte del paziente) in ciascuna visita fino alla Settimana 112
    • Percentuale di soggetti soddisfatti del trattamento dello studio (buono, molto buono o eccellente) nella scala Likert a 5 punti Patient Global Assessment of Treatment (valutazione globale del trattamento da parte del paziente) in ciascuna visita fino alla Settimana 112
    • Percentuale di soggetti che ricevono trattamenti concomitanti per AD, per tipo di trattamento (ad es. topico, fototerapia, sistemico), nel periodo di trattamento
    • Percentuale di soggetti che ricevono trattamenti di salvataggio, per tipo di trattamento di salvataggio in qualsiasi visita durante il periodo di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    Come specificato nell'elenco degli endpoint
    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, Quality of life
    Immunogenicità, qualità della vita
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Studio in aperto; I soggetti provenienti da studi in cieco riceveranno un trattamento in cieco al gi
    Open trial; Subjects from blinded studies will receive blinded treatment on Day 1 to maintain the bl
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA162
    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
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    New Zealand
    Poland
    Romania
    Singapore
    Spain
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days23
    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: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1045
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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
    Adolescents aged 12-17
    Adolescenti 12-17 anni
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 639
    F.4.2.2In the whole clinical trial 1300
    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 will revert back to their primary physician for further evaluation.
    I pazienti torneranno al loro medico primario per ulteriori valutazione.
    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 Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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