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    Summary
    EudraCT Number:2016-000674-38
    Sponsor's Protocol Code Number:M14-533
    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:2021-06-17
    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 number2016-000674-38
    A.3Full title of the trial
    A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)
    Sperimentazione multicentrica di estensione a lungo termine di Fase 3 per valutare la sicurezza e l'efficacia di Upadacitinib (ABT-494) in soggetti affetti da colite ulcerosa (CU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.
    Sperimentazione a lungo termine per valutare la sicurezza e l'efficacia di ABT-494 in soggetti affetti da colite ulcerosa.
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberM14-533
    A.5.4Other Identifiers
    Name:N.A.Number:M14-533
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL64UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameUpadacitinib
    D.3.2Product code [ABT-494]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    D.IMP: 2
    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 nameUpadacitinib
    D.3.2Product code [ABT-494]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    D.IMP: 3
    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 nameUpadacitinib
    D.3.2Product code [ABT-494]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Colite ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite ulcerosa
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 Long-Term Safety and Efficacy of ABT-494
    Valutare la sicurezza e l'efficacia a lungo termine di ABT-494
    E.2.2Secondary objectives of the trial
    None.
    Nessuno.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has not responded at the end of the induction period (Week 8) in Study M14-234 (Substudies 1 and 2), who has been an inadequate responder during the maintenance period of Study M14-234 (Substudy 3), or who has responded and successfully completed Study M14-234 substudy 3.
    During the coronavirus SARS-CoV-2 pandemic, for subjects with missing
    endoscopy due to the coronavirus SARS-CoV-2 pandemic in studies M14-
    234 SS2, SS3 and M14-675 those following subjects may be enrolled if
    the below criteria is met:
    Subjects who achieved clinical response defined by Partial Adapted Mayo
    Score at Week 8 of Studies M14-234 SS2 and M14-675
    ¿ Subjects who achieved clinical response defined by Partial Adapted
    Mayo Score at Week 16 in the extended treatment period of Studies
    M14-234 SS2 and M14-675
    Note: If endoscopy is missing at Week 8 but can be performed at Week
    16, Week 16 endoscopy should be performed. However, the status of
    clinical response will be defined by Partial Adapted Mayo Score and
    clinical responders may enter Study M14-533 Cohort 1.
    ¿ Subjects who have completed the 52-week treatment in Study M14-
    234 SS3 if the PI considers it is safe to continue based on phone/video
    call, subject's medical history and findings from the last endoscopy.
    2. Women of childbearing potential (refer to Section 5.2.4) must have a negative urine pregnancy test at Week 0 visit.
    3. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations
    4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study .
    5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
    1. Soggetto che non abbia ottenuto una risposta clinica alla fine del periodo di induzione (Settimana 8) della Sperimentazione M14-234 (Sottostudi 1 e 2), che abbia perso la risposta nel corso del periodo di mantenimento della Sperimentazione M14-234 (Sottostudio 3) oppure che abbia completato con successo la Sperimentazione M14-234 sottostudio 3.
    Nel corso della pandemia COVID-19, gli sperimentatori dovranno fare quanto possibile per eseguire le
    endoscopie secondo quanto richiesto dal protocollo. Per i soggetti per cui manca una endoscopia nel
    periodo in cui l’esecuzione di endoscopie era proibita a causa della pandemia COVID-19 nell’ambito dello
    Studio M14-234 Sottostudio 2, Sottostudio 3 oppure dello Studio M14-675,una segnalazione deve essere
    inviata al TA MD per comunicare lo Stato relativo alla risposta e in quale parte del programma entrerà il
    soggetto prima che abbia luogo il trasferimento
    Upadacitinib
    M14-533 Protocol Amendment 54
    EudraCT 2016-000674-38
    Page 2 of 9
    1. Soggetti che hanno ottenuto la risposta clinica definita sulla base del punteggio Partial Adapted Mayo
    Score alla Settimana 8 degli Studi M14-234 Sottostudio 2 e M14-675.
    2. Soggetti che hanno ottenuto la risposta clinica definita sulla base del punteggio Partial Adapted Mayo
    Score alla Settimana 16 nell’ambito del periodo di estensione del trattamento degli Studi M14-234
    Sottostudio 2 e M14-675
    Nota: Se manca l’endoscopia alla Settimana 8 ma è possibile eseguire l’endoscopia alla Settimana
    16, si dovrà eseguire l’endoscopia della Settimana 16. Tuttavia, lo stato della risposta clinica alla
    Settimana 16 sarà determinato sulla base del punteggio Partial Adapted Mayo Score e i soggetti
    con risposta clinica (clinical responders) possono entrare nello Studio M14-533 Coorte 1
    3. Soggetti che hanno completato il trattamento della durata di 52 settimane nell’ambito dello Studio
    M14-234 Sottostudio 3 purché lo sperimentatore principale ritenga che sia sicuro continuare sulla base di
    contatto telefonico/video, dell’anamnesi del soggetto e dei riscontri dell’ultima endoscopia.

    2. Le donne in età fertile (vedere la Sezione 5.2.4) devono sottoporsi a un test di gravidanza su urine che dovrà essere negativo negativo alla Settimana 0.
    3. I soggetti di sesso femminile dovranno soddisfare i criteri di contraccezione riportati in questo
    protocollo.
    4. Soggetto le cui condizioni di salute, ad esclusione della colite ulcerosa, sono considerate buone a giudizio dello sperimentatore principale, in base alle valutazioni cliniche eseguite nel corso della sperimentazione precedente.
    5. Soggetto in grado e disponibile a rilasciare il proprio consenso informato scritto e ad attenersi ai requisiti di questo protocollo per la sperimentazione.
    E.4Principal exclusion criteria
    1. For any reason subject is considered by the investigator to be an unsuitable candidate.
    2. 2. Female subject with a positive pregnancy test at Baseline (final visit of the preceding studies) or who is considering becoming pregnant during the study and within 30 days after the last dose of study drug.
    3. Subject with an active or recurrent infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been
    successfully treated.
    4. 4. Current evidence of active tuberculosis; Current evidence of latent tuberculosis and for any reason the subject cannot take full course of TB prophylaxis treatment
    5. Subject with a poorly controlled medical condition, such asuncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, (New
    York Heart Association class III or IV),recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
    1. Soggetto che per qualsiasi motivo non è considerato un candidato idoneo dallo sperimentatore.
    2.Soggetti di sesso femminile con risultato positivo del test di gravidanza eseguito alla visita finale degli studi clinici precedenti oppure che intendono iniziare una gravidanza nel
    corso dello Studio clinico o entro 30 giorni dopo l’ultima dose di farmaco sperimentale..
    3. Soggetto con infezione in fase attiva o ricorrente che secondo le valutazioni cliniche dello
    sperimentatore rendono il soggetto non idoneo per lo Studio clinico. I soggetti con infezione in corso e in trattamento potranno essere arruolati TUTTAVIA NON riceveranno trattamento fino a completa risoluzione dell’infezione.
    4. Attuale evidenza di tubercolosi attiva; evidenza attuale di tubercolosi latente e
    per qualsiasi motivo il soggetto non può assumere un ciclo intero di trattamento profilattico contro la
    tubercolosi secondo quanto richiesto dal protocollo
    5. Soggetto con condizione medica scarsamente controllata, ad esempio diabete non controllato, cardiopatia ischemica instabile, scompenso cardiaco congestizio moderato o grave, incidenti cerebrovascolari recenti e qualsiasi altra condizione che, a giudizio dello sperimentatore o del promotore, porrebbe il soggetto a rischio a causa della sua partecipazione a questa sperimentazione
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to evaluate the long-term safety and tolerability of upadacitinib through the assessment of the incidence of treatment-emergent adverse events, changes in vital signs, physical examination results, and clinical laboratory data.
    L’endpoint primario dello studio è rappresentato dalla valutazione della sicurezza e tollerabilità a lungo termine di upadacitinib in base alla valutazione dell’incidenza di eventi avversi emergenti dal trattamento, variazioni nei segni vitali, riscontri all’esame obiettivo e dati clinici di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    288 weeks
    288 settimane
    E.5.2Secondary end point(s)
    The clinical remission or response will be evaluated using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted Mayo score (Full Mayo score excluding Physician's
    Global Assessment), or Partial Mayo score (Full Mayo score excluding endoscopic subscore).
    La remissione clinica o la risposta saranno valutate utilizzando il punteggio Full Mayo Score (Mayo Scoring System for Assessment of Ulcerative Colitis Activity), il punteggio Adapted Mayo Score (punteggio Full Mayo Score con l¿esclusione del punteggio PGA [Physician¿s Global Assessment, Valutazione Globale del Medico]) oppure il punteggio Partial Mayo score (punteggio Full Mayo Score con l¿esclusione del sottopunteggio endoscopico).
    E.5.2.1Timepoint(s) of evaluation of this end point
    288 weeks
    288 settimane
    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 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Argentina
    Australia
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Croatia
    Egypt
    Israel
    Japan
    Kazakhstan
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    New Zealand
    Norway
    Puerto Rico
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days27
    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: 19
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 891
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 950
    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)
    Following completion of the study, subjects will be treated at the Investigator's discretion and in accordance with local standard of care
    Dopo la conclusione della sperimentazione, i soggetti saranno trattati secondo il giudizio del Medico sperimentatore ed in accordo con le terapie standard locali.
    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 Decision2016-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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