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    Summary
    EudraCT Number:2020-000287-32
    Sponsor's Protocol Code Number:D325AC00002
    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:2021-05-24
    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 number2020-000287-32
    A.3Full title of the trial
    A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid
    Studio multinazionale, randomizzato, in doppio cieco, a gruppi paralleli, controllato verso placebo per valutare l’uso di benralizumab come opzione terapeutica per pazienti affetti da pemfigoide bolloso (FJORD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the use of benralizumab in patients with bullous pemphigoid
    Uno studio per indagare l'uso di benralizumab in pazienti con pemfigoide bolloso
    A.3.2Name or abbreviated title of the trial where available
    FJORD
    FJORD
    A.4.1Sponsor's protocol code numberD325AC00002
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013028851180
    B.5.6E-mailinformation.center@astrazeneca.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 nameBenralizumab
    D.3.2Product code [MEDI-563]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNBenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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
    Bullous Pemphigoid
    Pemfigoide bolloso
    E.1.1.1Medical condition in easily understood language
    Rare, autoimmune, chronic relapsing skin disorder characterized by blistering, hives and itching
    Malattia della pelle recidivante rara, autoimmune, cronica caratterizzata da vesciche, orticaria e prurito
    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 10006567
    E.1.2Term Bullous pemphigoid
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of benralizumab with placebo in participants with symptomatic BP
    Confrontare l’efficacia clinica di benralizumab rispetto al placebo nei partecipanti con PB sintomatico
    E.2.2Secondary objectives of the trial
    1. To compare the effect of benralizumab with placebo on supportive measures of clinical efficacy in participants with symptomatic BP up to Week 36.
    2. To compare the effect of benralizumab with placebo on clinical efficacy in participants with symptomatic BP up to Week 16.
    3. To estimate the PK and immunogenicity of benralizumab in participants with BP.
    1. Confrontare l’effetto di benralizumab rispetto al placebo sulle misure di supporto di efficacia clinica nei partecipanti con PB sintomatico fino alla Settimana 36
    2. Confrontare l’effetto di benralizumab rispetto al placebo sull’efficacia clinica nei partecipanti con BP sintomatico fino alla Settimana 16
    3. Stimare la PK e l’immunogenicità di benralizumab nei partecipanti con PB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult participants = 18 years of age
    2. Participants must have clinical features of BP (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening visit and confirmed diagnosis with histology, direct immunofluorescence, and serology at randomization. Required for inclusion:
    (a) Histology.
    (b) Positive direct immunofluorescence (from skin biopsy) (IgG and/or C3 at the
    basement membrane zone).
    (c) AND at least one of the following serologic assessments positive (all assessed from
    participant’s blood sample):
    (i) indirect immunofluorescence (IgG on the roof of salt- split skin).
    (ii) positive serology on ELISA for BPAG1 (230-kd).
    (iii) positive serology on ELISA for BPAG2 (180-kd).
    3. BPDAI activity score = 24 at the screening and randomization visits.
    4. Candidate for systemic corticosteroid therapy.
    1. Partecipanti adulti di età =18 anni
    2. I partecipanti devono presentare caratteristiche cliniche di pemfigoide bolloso (bullous pemphigoid, BP) come ad es. placche urticanti o eczematose o eritematose, bolle, e prurito alla visita di screening e diagnosi confermata con istologia, immunofluorescenza diretta,
    e sierologia al momento della randomizzazione. Requisiti per l’inclusione:
    (a) Istologia.
    (b) Immunofluorescenza diretta positiva (dalla biopsia cutanea) (IgG e/o C3 lungo la zona della membrana basale).
    (c) E almeno una delle seguenti valutazioni sierologiche positive (tutte valutate in base al campione ematico del partecipante):
    (i) immunofluorescenza indiretta (IgG sulla parte superiore della salt split skin).
    (ii) sierologia positiva in ELISA per BPAg1 (230 kD).
    (iii) sierologia positiva in ELISA per BPAg2 (180 kD).
    3. Punteggio di attività BPDAI =24 alle visite di screening e di randomizzazione.
    4. Candidato per terapia corticosteroidea sistemica.
    E.4Principal exclusion criteria
    1. Forms of BP other than classic, predominantly cutaneous BP: eg, mucous membrane BP, epidermolysis bullosa acquisita, Brunsting-Perry BP, p200 BP, p105 BP, BP with
    2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
    (a) Affect the safety of the participant throughout the study.
    (b) Influence the findings of the studies or their interpretations.
    (c) Prevent the participant’s ability to complete the entire duration of study.
    (d) Impact the participant’s ability to complete the required PRO assessments.
    3. Current malignancy, or history of malignancy, except for:
    (a) Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent when applicable was obtained.
    (b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
    4. History of anaphylaxis to any biologic therapy or vaccine.
    5. History of Guillain-Barré syndrome.
    6. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
    7. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study.
    8. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the participant at risk or interfere with study assessments.
    9. Current active liver disease.
    (a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody), or other stable chronic liver disease are acceptable if subject otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
    (b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =3 times the upper limit of normal, confirmed by repeated testing during screening period.
    10. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
    11. Use of immunosuppressive medication (including but not limited to: methotrexate, cyclosporine, azathioprine,
    12. Receipt of immunoglobulin or blood products within 30 days prior to the date informed
    13. Receipt of any marketed (eg, omalizumab) or investigational biologic within 4 months or
    5 half-lives prior to the date informed consent is obtained, whichever is longer.
    14. Known history of allergy or reaction to any component of the IP formulation.
    15.
    1. Forme di BP diverse dal classico BP preval cutaneo: come ad es. BP membrane mucose, epidermolisi bollosa acquisita, BP di Brunsting-Perry, BP p200, BP p105, BP con pemfigo volgare concomitante, BP indotto da farmaci (ad es. insorgenza o attuale aggravamento da inibitori dell’enzima di conversione dell’angiotesina, penicillamina, furosemide, fenacetina, inibitori della dipeptidil-peptidasi 4 o alcune terapie immuno-oncologiche).
    2. Qualsiasi disturbo, cardiov, gastrointest, epatico, renale, neurologico, muscoloschel, infettivo, endocrino, metabolico, ematologico, psichiatrico o menomazione fisica grave, che non sia stabile a giudizio del PI e che potrebbe:
    (a) Compromettere la sicurezza del partecipante per tutta la durata dello studio.
    (b) Influenzare i risultati degli studi o le loro interpretazioni.
    (c) Impedire al partecipante di completare lo studio nella sua intera durata.
    (d) Compromettere la capacità del partecipante di completare le valutazioni degli esiti riferiti dal paziente (patient-reported outcome, PRO) richieste.
    3. Tumore maligno attuale o anamnesi di tumore maligno, eccetto:
    (a) I partecipanti che hanno sofferto di carcinoma a cellule basali, carcinoma cutaneo a cellule squamose localizzato o carcinoma in situ della cervice sono idonei a condizione che il partecipante sia in remissione e la terapia curativa sia stata completata almeno 12 mesi prima della data del consenso informato, e che sia stato ottenuto il consenso, ove applicabile.
    (b) I partecipanti che hanno avuto altri tumori maligni sono idonei a condizione che il partecipante sia in remissione e che la terapia curativa sia stata completata almeno 5 anni prima della data del consenso informato,
    4. Anamnesi di anafilassi a qualsiasi terapia con biofarmaci o vaccino.
    5. Anamnesi di sindrome di Guillain-Barré.
    6. Un’infezione parassitaria elmintica diagnosticata nelle 24 settimane precedenti alla data di ottenimento del consenso informato, che non è stata trattata
    7. Qualsiasi riscontro anomalo clinicamente significativo nell’esame obiettivo, nei segni vitali, nell’ematologia, nella chimica clinica o nell’esame dell’urina durante lo screening, che a giudizio del PI potrebbe mettere a rischio il
    8. Qualsiasi cardiopatia clinicamente significativa o qualsiasi anomalia dell'ECG ottenuta durante screening/run-in, che a giudizio del PI potrebbe mettere il partecipante a rischio o interferire con le valutazioni dello studio.
    9. Attuale malattia epatica attiva.
    (a) Epatite B e C cronica stabile o altra malattia epatica cronica stabile sono accettabili se il soggetto altrimenti soddisfa i criteri di idoneità
    (b) Livello di ALT o AST =3 volte il limite sup dell’intervallo normale, confermato da test ripetuti durante il periodo di screening. Un aumento transitorio del livello di AST/ALT che si risolve entro la data della randomizzazione è accettabile se, a giudizio del PI, il soggetto non presenta una malattia epatica attiva e soddisfa altri criteri di idoneità.
    10. Anamnesi di disturbo da immunodeficienza noto, compreso un test positivo per il virus dell’immunodeficienza umana (HIV).
    11. Uso di farmaci immunosoppressori (inclusi, a titolo esemp ma non esaust: metotrexato, ciclosporina, azatioprina, corticosteroide intramuscolare (IM) a rilascio prolungato o qualsiasi terapia antinfiammatoria sperimentale) nei 3 mesi prec data di ottenimento del CI.
    12. Ricezione di immunoglobulina o di prodotti ematici nei 30 giorni precedenti alla data di ottenimento del consenso informato.
    13. Ricezione di qualsiasi biofarmaco commercializzato (ad es. omalizumab) o sperimentale nei 4 mesi o nelle 5 emivite pre data di ottenimento del CI a seconda di quale sia il periodo più lungo.
    14. Anamnesi nota di allergia o reazione a qualsiasi componente della formulazione del prodotto sperimentale.
    1..
    E.5 End points
    E.5.1Primary end point(s)
    A binary response, whereby a responder is defined as a participant who is in partial or complete
    remission while off OCS for = 2 months at Week 36.
    Una risposta binaria, in cui un risponditore è definito come un partecipante che è parziale o completo
    remissione durante l'assenza di OCS per = 2 mesi alla settimana 36.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 36
    Alla settimana 36
    E.5.2Secondary end point(s)
    Key secondary :
    • Proportion of participants who remain relapse-free up to Week 36.
    • Cumulative OCS exposure (mg/kg) from baseline to Week 36.
    • Change from baseline in BPDAI activity score at Week 36.
    • Change from baseline in BPDAI-Pruritus at Week 36.
    • Cumulative OCS exposure (mg/kg) from baseline to Week 16.
    Secondario chiave:
    • Proporzione di partecipanti che rimangono liberi da ricadute fino alla settimana 36.
    • Esposizione cumulativa a OCS (mg / kg) dal basale alla settimana 36.
    • Variazione rispetto al basale nel punteggio di attività BPDAI alla settimana 36.
    • Variazione rispetto al basale in BPDAI-Pruritus alla settimana 36.
    • Esposizione cumulativa a OCS (mg / kg) dal basale alla settimana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    various time points as per protocol
    diversi come da protocollo
    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 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Bulgaria
    France
    Germany
    Israel
    Italy
    Japan
    Spain
    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
    Last Patient Last Visit
    Ultima Visita Ultimo Paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Incapacitated subjects are not excluded. Legally authorized representative will be required to consent.
    I soggetti inabili non sono esclusi. Legalmente autorizzato
    rappresentante sarà tenuto a dare il consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 120
    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)
    After the end of the study, the participant should be given standard of care therapy according to local practice, at the discretion of the Investigator.
    Dopo la fine dello studio, al partecipante dovrebbe essere assegnato lo standard di
    terapia assistenziale secondo la pratica locale, a discrezione dell '
    Investigatore.
    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 Decision2021-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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