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    Summary
    EudraCT Number:2017-001240-35
    Sponsor's Protocol Code Number:M14-433
    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:2021-06-15
    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 number2017-001240-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies.
    Sperimentazione Multicentrica, Randomizzata, in Doppio Cieco, Controllata verso Placebo e di Induzione per Valutare l’Efficacia e la Sicurezza di Upadacitinib (ABT-494) in Soggetti affetti da Malattia di Crohn in Fase Attiva e di Grado da Moderato a grave che hanno avuto una risposta inadeguata o sono intolleranti alle terapie convenzionali, in assenza di fallimento di terapia con biologici.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional e/o Biologiche Therapies.
    Sperimentazione di Efficacia e Sicurezza di Upadacitinib (ABT-494) in Soggetti affetti da Malattia di Crohn in Fase Attiva e di Grado da Moderato a grave che hanno avuto una risposta inadeguata o sono intolleranti alle terapie convenzionali e/o Biologiche.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM14-433
    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 codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628561090
    B.5.5Fax number441628461153
    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 coden/a
    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 number45
    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 coden/a
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease (CD)
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    CD is an inflamatory bowel disease affects the lining of the digestive tract, often spreads into the layers of affected bowel tissue, can lead to abdominal pain, severe diarrhea, fatigue, weight loss.
    Il CD è una malattia infiammatoria intestinale che colpisce il tratto digestivo, si diffonde spesso nel tessuto intestinale interessato, può portare a dolore addominale, grave diarrea, affaticam
    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 10011401
    E.1.2Term Crohn's disease
    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
    The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
    L’obiettivo della Sperimentazione è quello di valutare l’efficacia e la sicurezza di Upadacitinib rispetto a placebo come terapia di induzione in soggetti affetti da malattia di Crohn in fase attiva e di grado da moderato a grave.
    E.2.2Secondary objectives of the trial
    To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.
    Valutare i miglioramenti nei diversi parametri di efficacia, compresa la sospensione degli steroidi, i
    parametri di laboratorio e i questionari sulla qualità della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of CD for at least 3 months prior to Baseline.
    - Confirmed diagnosis of moderate to severe CD as assessed by stool
    frequency (SF), abdominal pain (AP) score.
    - Evidence of mucosal inflammation based on the Simplified Endoscopic
    Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a
    central reader.
    - Demonstrated an inadequate response or intolerance to one or more
    conventional and/or biologic therapies, in the opinion of the
    investigator, as defined below:
    Oral locally acting steroids
    Intravenous or oral corticosteroids
    Immunosuppressants
    Biologic therapies for CD
    Note: Non-bio-IR subjects who have received prior biologic for up to 1
    year but have not failed may be enrolled; however, participants must
    have discontinued the biologic for reasons other than inadequate
    response or intolerance (e.g., change of insurance, well controlled
    disease),
    - If female, subject must meet the contraception recommendations.
    - Diagnosi confermata della malattia di Crohn da almeno 3 mesi prima della Baseline.
    - Diagnosi confermata della Malattia di Crohn da moderata a grave come valutato dal punteggio di frequanza della feci (SF), dolore addominale(AP)
    - Evidenza di infiammazione della mucosa basata sul punteggio endoscopico semplificato per la malattia di Crohn (SES-CD) su endoscopia confermata da una valutazione centralizzata.
    - Risposta inadeguata o intolleranza, confermata da evidenze, a una o più delle seguenti terapie convenzionali e/o biologiche a giudizio dello sperimentator, come definito di seguito:
    Steroidi orali ad azione locale, Corticosteroidi per via endovenosa oppure orale , Immunosoppressori, Terapie biologiche per CD
    NB: I soggetti che hanno ricevuto una pregressa terapia con biologici per più di 1 anno ma senza fallimento potranno essere arruolati, tuttavia, dovranno aver interrotto il medicinale biologico per motivi diversi dalla risposta inadeguata o intolleranza (es., variazione della copertura assicurativa, controllo soddisfacente della malattia).
    - Se donna, il soggetto dove soddisfare le raccompandazioni sulla contraccezione.
    E.4Principal exclusion criteria
    -Subject with a current diagnosis of ulcerative colitis or indeterminate
    colitis.
    - Subject not on stable doses of CD related antibiotics, oral
    aminosalicylates, corticosteroids or methotrexate (MTX).
    - Subject with the following known complications of CD: abscess
    (abdominal or peri-anal), > 2 entire missing segments of the following 5
    segments: terminal ileum, right colon, transverse
    colon, sigmoid and left colon, and rectum, symptomatic bowel strictures,
    fulminant colitis, toxic megacolon, or any other manifestation that might
    require surgery while enrolled in the study.
    - Subject with ostomy or ileoanal pouch
    - Subject diagnosed with short gut or short bowel syndrome
    - Screening laboratory and other analyses show abnormal results.
    - Soggetto con diagnosi attuale di colite ulcerosa oppure colite di natura indeterminata
    - Soggetto in trattamento con antibiotici, aminosalicilati orali, corticosteroidi o Metotressato (MTX) somministrati per la malattia di Crohn la cui dose non è rimasta stabile.
    - Soggetto con presenza nota delle seguenti complicanze associate alla malattia di Crohn:ascesso (addominale o perianale), restringimenti intestinali sintomatici, > 2 segmenti interi mancanti dei seguenti 5 segmenti: ileo terminale, colon destro, colon trasverso, colon sigmoideo e sinistro e retto, colite fulminante
    - Soggetto con stomia o serbatoio ileoanale
    - Soggetto con diagnosi di sindrome dell’intestino corto
    - Risultati di laboratorio e altre analisi che evidenziano valori anomali.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary Endpoints:
    1. Proportion of subjects with clinical remission per PROs at Week 12, and
    2. Proportion of subjects with endoscopic response at Week 12.
    Endpoint Co-primari:
    1. Percentuale di soggetti che presentano remissione clinica per PROs alla Settimana 12, e
    2. Percentuale di soggetti con risposta endoscopica alla Settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1. Proportion of subjects with clinical remission per CDAI (CDAI < 150)
    2. Proportion of subjects with clinical remission at Week 4
    3. Proportion of subjects with endoscopic remission at Week 12
    4. Proportion of subjects who discontinue corticosteroid use for CD and
    achieve clinical remission at Week 12, in subjects taking corticosteroids
    for CD at Baseline
    5. Change from Baseline in FACIT-F at Week 12
    6. Change from Baseline in IBDQ at Week 12
    7. Proportion of subjects achieving CR-100 at Week 2
    8. Proportion of subjects achieving CR-100 at Week 12
    9. Proportion of subjects with hospitalizations due to CD during the 12
    week double-blind induction period
    10. Proportion of subjects with resolution of extra-intestinal
    manifestation (EIM) at week 12, in subjects with EIM at Baseline
    1. Percentuale di soggetti con remissione clinica in base al punteggio CDAI (CDAI < 150)
    2. Percentuale di soggetti con remissione clinica alla Settimana 4
    3. Percentuale di soggetti con remissione endoscopica alla Settimana 12
    4. Percentuale di soggetti che interrompono l’utilizzo di corticosteroidi assunti per la malattia di Crohn e ottengono la remissione clinica alla Settimana 12, fra i soggetti che al Baseline erano in trattamento con corticosteroidi per la malattia di Crohn.
    5. Variazione rispetto al basale nella valutazione funzionale della terapia cronica per la malattia-affaticamento alla settimana 12
    6. Variazione rispetto al Baseline del punteggio IBDQ (Inflammatory Bowel Disease Questionnaire) alla settimana 12
    7. Percentuale di soggetti che ottengono CR-100 alla Settimana 2
    8. Percentuale di soggetti che ottengono CR-100 alla Settimana 12
    9. Percentuale di soggetti con ospedalizzazioni a causa di CD durante il periodo di induzione in doppio cieco della durata di 12 settimane
    10. Percentuale di soggetti con risoluzione delle manifestazioni extra-intestinali (extra-intestinal manifestations, EIM) alla Settimana 12, in soggetti che presentavano EIM al Baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 12
    2. week 4
    3. week 12
    4. week 12
    5. week 12
    6. week 12
    7. week 2
    8. week 12
    9. week 12
    10. week 12
    1. Settimana 12
    2. Settimana 4
    3. Settimana 12
    4. Settimana 12
    5. Settimana 12
    6. Settimana 12
    7. Settimana 2
    8. Settimana 12
    9. Settimana 12
    10. Settimana 12
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA146
    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
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Egypt
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Puerto Rico
    Russian Federation
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days14
    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: 476
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 501
    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)
    Subjects who achieve clinical response at week 12 or 24 may be enrolled in the maintenance/long-term extension study M14-430 with upadacitinib. Subjects who do not achieve clinical response to upadacitinib at week 24 will receive standard of care treatment, per the investigator’s decision.
    I soggetti che ottengono una risposta clinica alla settimana 12 o 24 possono essere arruolati nello studio di estensione di mantenimento/a lungo termine M14-430 con upadacitinib. I soggetti che non ottengono una risposta clinica all'upadacitinib alla settimana 24 saranno sospesi dal trattamento e riceveranno un trattamento standard di cura, secondo la decisione dello sperimentatore.
    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 Decision2018-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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