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    Summary
    EudraCT Number:2017-000873-35
    Sponsor's Protocol Code Number:I4V-MC-JAHN
    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:2021-06-14
    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 number2017-000873-35
    A.3Full title of the trial
    Protocol I4V-MC-JAHN: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

    Studio di fase 3 multicentrico in doppio cieco che valuta la sicurezza e l¿efficacia a lungo termine di baricitinib in pazienti adulti con dermatite atopica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a long term extention study in patients with Atopic Dermatitis, also named eczema, that helps to understand how Baricitinib works
    Studio a lungo termine in pazienti con dermatite atopica, anche conosciuta come eczema, che contribuisce a capire come Baricitinib agisca.
    A.3.2Name or abbreviated title of the trial where available
    BREEZE AD-3: BaRicitinib in moderate to sEvere EcZEma in Atopic Dermatitis-3
    BREEZE AD-3:BaRicitinib in moderate to sEvere EcZEma in Atopic Dermatitis-3
    A.4.1Sponsor's protocol code numberI4V-MC-JAHN
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpsenweg 83, 3528 BJ; Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 No
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    Atopic Dermatitis
    Dermatite Atopica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis also known as Eczema
    Dermatite atopica conosciuta anche come eczema
    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 of this long term extention trial is to estimate the effect of long term therapy with baricitinib on responders and partial responders at entry of JAHN.
    L¿obiettivo primario di questa sperimentazione di estensione a lungo termine ¿ quello di valutare l¿effetto della terapia a lungo termine con baricitinib sui responder e sui responder parziali all¿ingresso nello studio JAHN.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient reported outcomes.
    To evaluate the effect of starting baricitinib on clinical measures and patient reported outcomes.
    To evaluate the effect of maintaining baricitinib dose on clinical measures.
    Valutare l¿effetto dell¿aumento o del mantenimento della dose di baricitinib sulle misure cliniche e sugli esiti riferiti dal paziente.
    Valutare l¿effetto dell¿inizio dell¿assunzione di baricitinib sulle misure cliniche e sugli esiti riferiti dal paziente.
    Valutare l¿effetto del mantenimento della dose di baricitinib sulle misure cliniche.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Study JAHN will evaluate the effect of stopping or decreasing the dose of
    baricitinib in the context of a randomized treatment withdrawal and
    downtitration substudy starting at Week 52.
    Objectives:
    To evaluate the change in clinical response after treatment withdrawal
    or down titration.
    To evaluate for patients retreated during substudy the ability to
    recapture efficacy based on clinical measures after experiencing a loss of
    treatment benefit.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Lo studio JAHN valuter¿ l¿effetto a seguito dell¿interruzione o della diminuzione della dose di baricitinib nel contesto di un sottostudio che prevede il ritiro randomizzato dal trattamento e una riduzione graduale della dose a partire dalla settimana 52. Obiettivi:
    Valutare il cambiamento della risposta clinica dopo il ritiro dal trattamento o la riduzione graduale della dose.
    Per i pazienti sottoposti nuovamente a trattamento durante il sottostudio, valutare la capacit¿ di recuperare l¿efficacia sulla base delle misure cliniche, dopo avere manifestato una perdita di beneficio del trattamento.
    E.3Principal inclusion criteria
    - Have completed the final active treatment visit for an originator study (such as JAHL or JAHM)
    - Are male or nonpregnant, nonbreastfeeding female patients.
    - Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product.

    - Avere completato la visita finale del trattamento attivo per uno studio di origine (come JAHL or JAHM)
    - Essere un paziente di sesso maschile, oppure di sesso femminile non gravida, non in allattamento.
    - I pazienti di sesso maschile o femminile potenzialmente fertili devono acconsentire a utilizzare un metodo anticoncezionale affidabile durante lo studio e per almeno 4 settimane dopo l’ultima dose di prodotto sperimentale.
    E.4Principal exclusion criteria
    - Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient
    if IP continues to be administered.
    - Had IP permanently discontinued at any time during a previous baricitinib study, except for patients who had IP discontinued during originating study
    due to rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate)
    - Had temporary IP interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study.
    - Presentare disturbi non controllati a livello cerebro-cardiovascolare, respiratorio, epatico, renale, gastrointestinale, endocrino, ematologico, neuropsichiatrico, oppure valori di laboratorio anomali sviluppati durante un precedente studio su baricitinib che, nell’opinione dello sperimentatore, pongono il paziente a un rischio non accettabile se IP continua a essere somministrato.
    - Avere sospeso in modo permanente PS in qualsiasi momento durante un precedente studio su baricitinib, fatta eccezione per i pazienti che hanno interrotto IP durante lo studio di origine, a causa di un intervento di emergenza con una terapia orale sistemica per la DA (per es. corticosteroidi, ciclosporina, metotrexato)
    - Avere avuto un’interruzione temporanea di PS e continuarla alla visita finale dello studio di uno studio precedente su baricitinib e, nell’opinione dello sperimentatore, ciò ponga un rischio inaccettabile per la partecipazione del paziente allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with a response of IGA 0 or 1
    Percentuale di pazienti che raggiungono il punteggio IGA pari a 0 o 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    16, 36 and 52 weeks after re-randomization of feeder trial
    16, 36 e 52 settimane dopo la nuova randomizzazione della sperimentazione originaria
    E.5.2Secondary end point(s)
    1. Proportion of patients with a response of IGA 0, 1, or 2
    2. Proportion of patients achieving response of EASI75 from baseline of
    originating study
    3. Proportion of patients with a 4-point improvement in Itch NRS from
    baseline of originating study
    4. Proportion of patients with a response of IGA 0 or 1
    1. Percentuale di pazienti che raggiungono il punteggio IGA pari a 0, 1 o 2
    2. Percentuale di pazienti che raggiungono il punteggio EASI75 dal basale dello studio di origine
    3. Percentuale di pazienti che raggiungono un miglioramento di 4 punti nel prurito sul punteggio NRS dal basale dello studio di origine
    4. Percentuale di pazienti che raggiungono il punteggio IGA pari a 0 o 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2: assessed at Weeks 16, 36, and 52
    3: assessed at week 16
    4: assessed at Weeks 16, 36, and 52 (nonresponders)
    1 e 2: valutato alle settimane 16, 36 e 52
    3: valutato alla settimana 16
    4: valutato alla settimana 16, 36 e 52 (non responders)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 EEA83
    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
    India
    Israel
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Taiwan
    Austria
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    Switzerland
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of the trial is definde as the date of the last visit (LVLS) or last scheduled procedure shown in the Schedule of Activities for the last patient as outlined in the protocol.
    La fine dello studio ¿ definita come la data dell'ultima visita (LVLS) o l'ultima procedura programmata riportata nella Schedule of Activities per l'ultimo paziente come delineato nel protocollo.
    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 months6
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 950
    F.4.2.2In the whole clinical trial 1500
    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)
    This is already an extension trial and includes patients from I4V-MC-JAHL and I4V-MC-JAHM feeder trials.
    This trial may be further extended.
    Questo è già un trial di estensione e include pazienti provenienti dai precedenti studi I4V-MC-JAHL e I4V-MC-JAHM.
    Questo processo più essere ulteriormente esteso.
    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 Decision2017-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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