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    EudraCT Number:2021-002967-23
    Sponsor's Protocol Code Number:M-17923-30
    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:2021-09-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002967-23
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
    Sperimentazione clinica di fase 3 randomizzata, in doppio cieco, controllata con placebo, per valutare l'efficacia e la sicurezza di lebrikizumab in combinazione con corticosteroidi topici in pazienti adulti e adolescenti con dermatite atopica da moderata a grave che non sono adeguatamente controllati con la ciclosporina o per i quali la ciclosporina non è consigliata dal punto di vista medico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lebrikizumab in patients with AD not adequately controlled or non-eligible for cyclosporine
    Efficacia e sicurezza di lebrikizumab in pazienti con DA non adeguatamente controllati o non eleggibili per ciclosporina
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberM-17923-30
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlmirall SA
    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 supportAlmirall, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall, S.A.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRonda General Mitre, 151
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.4Telephone number+34932913545
    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 nameLebrikizumab
    D.3.2Product code [LY3650150]
    D.3.4Pharmaceutical form Concentrate 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 INNlebrikizumab
    D.3.9.2Current sponsor codeLY3650150
    D.3.9.4EV Substance CodeSUB31913
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    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.1.2 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
    To evaluate the efficacy of lebrikizumab compared with placebo in patients not adequately controlled with cyclosporine or for
    whom cyclosporine is not medically advisable up to Week 16
    Valutare l'efficacia di lebrikizumab rispetto al placebo in pazienti non adeguatamente controllati con ciclosporina o per i quali la ciclosporina non è consigliata dal punto di vista medico fino alla Settimana 16.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy in patients not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable between Week 16 up to Week 52.
    Valutare l'efficacia in pazienti non adeguatamente controllati con ciclosporina o per i quali la ciclosporina non è consigliata dal punto di vista medico tra la Settimana 16 e la Settimana 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults and adolescents (aged =12 to <18 years at the time of ICF/IAF and weighing =40 kg)
    2. Chronic AD (according to Hanifin and Rajka Criteria¿2) that has been present for =1 year before the Screening visit
    3. EASI score =16 at the Baseline Visit
    4. IGA score =3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit
    5. =10% BSA of AD involvement at the Baseline visit
    6. Documented history by a physician of an inadequate response to existing topical medications within 6 months before Screening, defined as: inability to achieve good disease control (eg, not able to achieve IGA =2) after use of at least a moderatepotency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (eg, 14 days for ultra-high-potency TCS), whichever is shorter 7. Documented history by a physician of either:
    a) No previous CsA exposure and not currently a candidate for CsA
    treatment because of i. medical contraindications (eg, uncontrolled hypertension on medication), or ii. use of prohibited concomitant medications (eg, statins, digoxin, macrolide antibiotics, barbiturates, anti-seizure drugs, nonsteroidal antiinflammatory drugs, diuretics, angiotensin-converting-enzyme inhibitors, St John's Wort, etc.), or iii. increased susceptibility to CsA-induced renal damage (elevated creatinine) and/or liver damage (elevated function tests results), or
    iv. increased risk of serious infections, or v. hypersensitivity to CsA active substance or excipients OR:
    b) Previous exposure to CsA; CsA treatment should not be continued or restarted because of i. intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function test results, uncontrolled hypertension, araesthesia, headache, nausea, hypertrichosis); or ii. requirement for CsA at doses or durations beyond those specified in the
    prescribing information or inadequate response
    8. Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before randomisation
    9. Willing and able to comply with all clinic visits and study-related procedures and questionnaires
    10. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo
    11. Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a WOCBP
    12. Patient must provide signed ICF. Adolescent patients must also provide separate informed assent to enrol in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements)
    1. Adulti e adolescenti (di età compresa tra =12 e <18 anni al momento dell'ICF/IAF e di peso =40 kg)
    2. AD cronico (secondo i criteri di Hanifin e Rajka2) presente da =1 anno prima della visita di screening
    3. Punteggio EASI =16 alla visita di riferimento
    4. Punteggio IGA =3 (moderato) (scala da 0 [chiaro] a 4 [grave]) alla visita di riferimento
    5. BSA =10% di coinvolgimento di AD alla visita di riferimento
    6. 6. Anamnesi documentata da un medico di una risposta inadeguata ai farmaci topici esistenti entro 6 mesi prima dello screening, definita come: incapacità di ottenere un buon controllo della malattia (per esempio, non in grado di raggiungere un IGA =2) dopo l'uso di almeno un TCS a moderata potenza per almeno 4 settimane, o per la durata massima raccomandata dalle informazioni sulla prescrizione del prodotto (per esempio, 14 giorni per TCS ad altissima potenza), a seconda di quale sia la più breve 7. Anamnesi documentata da un medico di:
    a) Nessuna precedente esposizione a CsA e attualmente non candidato al trattamento con CsA
    trattamento a causa di i. controindicazioni mediche (ad es. ipertensione non controllata in terapia), o ii. uso di farmaci concomitanti vietati (ad es. statine, digossina, antibiotici macrolidi, barbiturici, farmaci antiepilettici, farmaci antinfiammatori non steroidei, diuretici, inibitori dell'enzima di conversione dell'angiotensina, erba di San Giovanni, ecc. ), o iii. maggiore suscettibilità al danno renale indotto dalla CsA (creatinina elevata) e/o al danno epatico (risultati elevati dei test di funzionalità), o
    iv. aumento del rischio di infezioni gravi, o v. ipersensibilità al principio attivo CsA o agli eccipienti OPPURE:
    b) precedente esposizione a CsA; il trattamento con CsA non deve essere continuato o ricominciato a causa di i. intolleranza e/o tossicità inaccettabile (per es. creatinina elevata, risultati di test di funzionalità epatica elevati, ipertensione non controllata, araestesia, mal di testa, nausea, ipertricosi); o ii. richiesta di CsA a dosi o durate oltre quelle specificate nelle
    informazioni sulla prescrizione o risposta inadeguata
    8. Voci complete del diario elettronico (eDiary) per il prurito e la perdita di sonno per un minimo di 4 dei 7 giorni precedenti la randomizzazione
    9. Disponibilità e capacità di rispettare tutte le visite cliniche e le procedure e i questionari relativi allo studio
    10. Per le donne in età fertile: accettare di rimanere astinenti (astenersi da rapporti eterosessuali) o di utilizzare un metodo contraccettivo altamente efficace durante il periodo di trattamento e per almeno 18 settimane dopo l'ultima dose di lebrikizumab o placebo
    11. I pazienti di sesso maschile devono accettare di utilizzare un metodo contraccettivo di barriera efficace durante lo studio e per un minimo di 18 settimane dopo l'ultima dose del farmaco in studio, se sessualmente attivi con un WOCBP
    12. Il paziente deve fornire un ICF firmato. I pazienti adolescenti devono anche fornire un consenso informato separato per iscriversi allo studio e firmare e datare o un IAF separato o l'ICF firmato dal genitore/tutore legale (come appropriato in base ai regolamenti e ai requisiti locali)
    E.4Principal exclusion criteria
    1. Participation in a prior lebrikizumab clinical study
    2. Treatment with IL-4 or IL-13 antagonists biological therapies before the Baseline visit.
    Exception: previous treatment with dupilumab will be allowed in a subset of patients. A wash-out of at least 8
    weeks before the Baseline visit will be required for this subpopulation
    3. Treatment with TCS within 1 week before the Baseline visit
    4. Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit
    5. Treatment with any of the following agents within 4 weeks before the Baseline visit:
    a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-¿, JAK inhibitors, azathioprine, methotrexate, etc.)
    b. Phototherapy and photochemotherapy (PUVA) for AD
    6. Treatment with the following before the Baseline visit:
    a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer;
    b. B cell-depleting biologics, including but not limited to rituximab, within 6 months;
    c. Other biologics within 16 weeks or 5 half-lives (if known) , whichever is longer
    7. Treatment with a live (attenuated) vaccine within 12 weeks of the Baseline visit, planned during the study, or 12 weeks after the study treatment is discontinued
    8. History of anaphylaxis as defined by the Sampson criteria¿40
    9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the Screening visit
    10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score =1.5 or a history of =2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for >24 hours)
    11. Have had any of the following types of infection within 3 months of Screening or develop any of these infections before randomization:
    a. Serious (requiring hospitalization, and/or IV or equivalent oral antibiotic treatment);
    b. Opportunistic (as defined in Winthrop et al. 2015). NOTE: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over;
    c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
    d. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis)
    12. Have a current or chronic infection with hepatitis B virus
    13. Have a current infection with hepatitis C virus (ie, positive for hepatitis C RNA)
    14. Have known liver cirrhosis and/or chronic hepatitis of any etiology
    15. Diagnosed active endoparasitic infections or at high risk of these infections
    16. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment
    17. History of HIV infection or positive HIV serology at Screening
    18. In the Investigator's opinion, any clinically significant laboratory test results from the chemistry, haematology, or urinalysis tests obtained at the Screening visit
    19. Presence of skin comorbidities that may interfere with study assessments
    For full list of please see the protocol.
    1.Partecipaz.a un preced.studio clinico con lebrikizumab
    2.Trattamento con terapie biologiche con antagonisti di IL-4 o IL-13 prima della visita di riferimento.Eccezione: un precedente trattamento con dupilumab sarà consentito in un sottogruppo di pazienti.Per questa sottopopolazione sarà richiesto un wash-out di almeno 8settimane prima della visita di riferimento
    3.Trattam.con TCS entro 1 settimana prima della visita di riferimento
    4.Trattam.con inibitori topici della calcineurina, inibitori della fosfodiesterasi-4 come il crisaborolo o cannabinoidi entro 2 settimane prima della visita di riferimento
    5.Trattam. con uno dei seguenti agenti entro 4settimane prima della visita di riferimento:
    a.Farmaci immunosoppressivi/immunomodulanti (es. corticosteroidi sistemici, ciclosporina, micofenolato-mofetile, interferone-¿, inibitore JAK, azatioprina, metotrexato, ecc.)
    b.Fototerapia e fotochemioterapia (PUVA) per AD
    6.Trattam.con quanto segue prima della visita di riferimento:
    a.Un farmaco sperimentale entro 8settimane o entro 5 semilavorati (se noti), a seconda di quale sia il più lungo;
    b.Biologici che impoveriscono le cellule B, incluso ma non limitato al rituximab, entro 6mesi;
    c.Altri biologici entro 16settimane o 5emivite (se note), a seconda di quale periodo sia più lungo
    7.Trattam.con un vaccino vivo (attenuato) entro 12 settimane dalla visita di riferimento, programmato
    durante lo studio, o 12 settimane dopo l'interruzione del trattamento di studio
    8.Storia di anafilassi come definita dai criteri di Sampson¿40
    9.Uso regolare (>2 visite a settimana) di una cabina/parrucchiere abbronzante entro 4 settimane dalla visita di screening
    10.Malattia cronica incontrollata che potrebbe richiedere l'uso di corticosteroidi orali, per esempio, comorbidità
    asma grave non controllata (definita da un punteggio ACQuestionnaire-5=1,5 o una storia di =2 esacerbazioni dell'asma negli ultimi 12 mesi che richiedono un trattamento corticosteroideo sistemico [orale e/o parenterale] o un ricovero ospedaliero per >24 ore)
    11.Hanno avuto uno dei seguenti tipi di infezione entro 3 mesi di Screening o sviluppare una di queste infezioni prima della randomizzazione:
    a.Gravi (che richiedono un'ospedalizzazione e/o un trattamento antibiotico orale per via endovenosa o equivalente);
    b.Opportunistica (come definito in Winthrop et al. 2015).NOTA: L'herpes zoster è considerato attivo e in corso fino a quando tutte le vescicole sono secche e incrostate;
    c.Cronico (durata dei sintomi, dei segni e/o del trattamento di 6 settimane o più);
    d.Ricorrente (incluso, ma non limitato a herpes simplex, herpes zoster, cellulite ricorrente
    cellulite, osteomielite cronica)
    12.Avere un'infezione attuale o cronica da virus dell'epatite B
    13.Avere un'infezione in corso con il virus dell'epatite C (cioè, positivo per l'epatite C RNA)
    14.Avere cirrosi epatica nota e/o epatite cronica di qualsiasi eziologia
    15.Infezioni endoparassitarie attive diagnosticate o ad alto rischio di queste infezioni
    16.Storia nota o sospetta di immunosoppressione, inclusa la storia di infezioni opportunistiche invasive (ad es. tubercolosi, istoplasmosi, listeriosi, coccidioidomicosi, pneumocistosi, aspergillosi) nonostante la risoluzione dell'infezione: o infezioni insolitamente frequenti, ricorrenti o prolungate, a giudizio dello sperimentatore
    17.Storia di infezione da HIV o sierologia +HIV allo screening
    18.A giudizio dello sperimentatore, qualsiasi risultato clinicamente significativo dei test di laboratorio di chimica, ematologia o analisi delle urine ottenuti alla visita di screening
    19.Presenza di comorbidità cutanee che possono interferire con le valutazioni dello studio
    Per lista completa vedasi il protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving EASI 75 (=75% reduction from Baseline in EASI score) at Week 16.
    Percentuale di pazienti che raggiungono l'EASI 75 (riduzione =75% dal Basale nel punteggio EASI) 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 achieving IGA 0/1 and 2-point improvement at Week 16.
    -Percentage of patients achieving a 4- point improvement Pruritus NRS at Week 16.
    - % of patients achieving EASI 90 at Week 16.
    - % patients achieving EASI 75, EASI 90 and EASI 50 (by visit up toWeek 16)
    - Change from Baseline BSA by visit up to Week 16
    - Change from Baseline SCORAD by visit up to Week 16
    - Change from Baseline Pruritus NRS by visit up to Week 16
    - Change from Baseline sleep loss by visit up to Week 16
    - Change from Baseline POEM by visit up to Week 16
    - Change from Baseline DLQI/CDLQI by visit up to Week 16
    - % patients achieving a 4-point improvement DLQI/CDLQI by visit up to Week 16
    - Proportion of TCS-free days from Baseline by visit up to Week 16
    -Time to TCS-free use (days) up to Week 16
    - Change from Baseline Skin Pain NRS by visit up to Week 16
    - % patients achieving a 4-point improvement Skin Pain NRS at Week
    -Percentuale di pazienti che raggiungono un miglioramento di IGA 0/1 e 2 punti alla settimana 16.
    -Percentuale di pazienti che raggiungono un miglioramento di 4 punti della Pruritus NRS alla settimana 16.
    - Percentuale di pazienti che raggiungono EASI 90 alla settimana 16.
    - % di pazienti che raggiungono EASI 75, EASI 90 e EASI 50 (per visita fino alla settimana 16)
    - Cambiamento rispetto al basale di BSA per visita fino alla settimana 16
    - Cambiamento rispetto al basale di SCORAD per visita fino alla settimana 16
    - Cambiamento dal valore basale di Pruritus NRS per visita fino alla settimana 16
    - Variazione dal valore basale della perdita di sonno, per visita fino alla settimana 16
    - Variazione dal valore basale di POEM per visita fino alla settimana 16
    - Variazione rispetto al basale del DLQI/CDLQI per visita fino alla settimana 16
    - Percentuale di pazienti che raggiungono un miglioramento di 4 punti DLQI/CDLQI per visita fino alla settimana 16
    - Percentuale di giorni senza TCS dal basale per visita fino alla settimana 16
    -Tempo di utilizzo senza TCS (giorni) fino alla settimana 16
    - Cambiamento dal basale del dolore cutaneo NRS per visita fino alla settimana 16
    - Percentuale di pazienti che raggiungono un miglioramento di 4 punti dell'NRS del dolore cutaneo alla settimana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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. 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 Yes
    E. trial design description
    2 parti dello studio - la prima in doppio cieco, la seconda parte in aperto
    2 part of the study - first double-blind, second part open label
    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 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 EEA70
    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
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 trial" is defined as the date when all patients randomised in the trial complete follow-up contact (either Treatment Completers or those Prematurely Discontinued), or are lost to follow-up and have not been able to be contacted, and will be communicated to Competent Authorities and the independent ethics committee (IEC) in due time according to local regulations.
    La "fine dello studio" è definita come la data in cui tutti i pazienti randomizzati nello studio completano il contatto di follow-up (sia quelli che completano il trattamento, sia quelli interrotti prematuramente), o sono persi al follow-up e non sono stati in grado di essere contattati, e sarà comunicata alle autorità competenti e al comitato etico indipendente (IEC) a tempo debito secondo le normative locali.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 39
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 312
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 312
    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)
    Once the last dose of study drug is taken (eg, the last visit at which the patient takes IMP [Week 52]) and related trial measurements are completed, patients should continue to take their usual medications, also allowed during the trial, and may resume other medications that were interrupted before trial enrolment as deemed appropriate by the Investigator.
    The study drug is for experimental use only, and there are other therapies available to treat the disease.
    Una volta che l'ultima dose di farmaco in studio è stata presa(es.l'ultima visita in cui il paziente assume l'IMP[Sett.52]) e le relative misurazioni dello studio sono completate,i paz.devono continuare a prendere i loro soliti farmaci,consentiti anche durante lo studio,e possono prendere altri farmaci interrotti prima dell'arruolamento nello studio,come ritenuto appropriato dal medico.
    Il farmaco in studio è solo per uso sperimentale,e ci sono altre terapie disponibili per trattare la
    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 Decision2022-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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