Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-000715-23
    Sponsor's Protocol Code Number:FIL_COLUMN
    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:2021-10-04
    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 number2021-000715-23
    A.3Full title of the trial
    Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy: a phase II study in BTKi-treated (or BTKi intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma
    (MCL) patients
    Consolidamento con ADCT-402 (loncastuximab tesirine) dopo un breve ciclo di immunochemioterapia: studio di fase II in pazienti con linfoma a cellule del mantello (MCL) recidivati/refrattari (R/R) dopo trattamento con inibitori della tirosina chinasi di Bruton (BTKi) o intolleranti a BTKi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Loncastuximab tesirine administered as a consolidation treatment after immunochemotherapy in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL)
    Loncastuximab tesirine somministrato come trattamento di consolidamento dopo immunochemioterapia in pazienti con linfoma a cellule del mantello (MCL) ricaduto/refrattario (R/R)
    A.3.2Name or abbreviated title of the trial where available
    FIL_COLUMN
    FIL_COLUMN
    A.4.1Sponsor's protocol code numberFIL_COLUMN
    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 SponsorFONDAZIONE ITALIANA LINFOMI ONLUS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportADC Therapeutics SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Linfomi
    B.5.2Functional name of contact pointUffici studi FIL
    B.5.3 Address:
    B.5.3.1Street AddressSpalto Marengo 44 - c/o Palazzo Pacto
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number0131033153
    B.5.5Fax number0131263455
    B.5.6E-mailstartup@filinf.it
    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 Zynlonta
    D.2.1.1.2Name of the Marketing Authorisation holderADC Therapeutics SA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/21/2481
    D.3 Description of the IMP
    D.3.1Product nameZynlonta
    D.3.2Product code [IMP1]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLoncastuximab Tesirine
    D.3.9.1CAS number 1879918-31-6
    D.3.9.2Current sponsor codeIMP1
    D.3.9.4EV Substance CodeSUB195566
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 typeAnticorpo monoclonale farmaco coniugato
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bruton Tyrosine Kinase inhibitors (BTKi) treated (or BTKi intolerant) relapsed/refractory (R/R) Mantle Cell Lymphoma (MCL).
    Linfoma a cellule del mantello (MCL) recidivati/refrattari (R/R) dopo trattamento con inibitori della tirosina chinasi di Bruton (BTKi) o intolleranti a BTKi.
    E.1.1.1Medical condition in easily understood language
    Bruton Tyrosine Kinase inhibitors (BTKi) treated (or BTKi intolerant) relapsed/refractory (R/R) Mantle Cell Lymphoma (MCL).
    Linfoma a cellule del mantello (MCL) recidivati/refrattari (R/R) dopo trattamento con inibitori della tirosina chinasi di Bruton (BTKi) o intolleranti a BTKi.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10026800
    E.1.2Term Mantle cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a consolidation with loncastuximab tesirine following salvage immunochemotherapy (2 courses of Rituximab-Bendamustine-Cytarabine, R-BAC) in Bruton Tyrosine Kinase inhibitors (BTKi) treated (or BTKi intolerant) relapsed/refractory (R/R) Mantle Cell Lymphomas (MCL).
    Valutare l'efficacia di un consolidamento con loncastuximab tesirine dopo una immunochemioterapia di salvataggio (2 cicli di Rituximab-Bendamustina-Citarabina, R-BAC) in pazienti con linfoma a cellule del mantello (MCL) recidivati/refrattari (R/R) dopo un trattamento con inibitori della tirosina chinasi di Bruton (BTKi) o intolleranti a BTKi.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety profile of loncastuximab tesirine consolidation.
    - To assess the rate of Minimal Residual Disease (MRD) negativity after loncastuximab tesirine consolidation.
    - Valutare il profilo di sicurezza del consolidamento con loncastuximab tesirine.
    - Valutare il tasso di negatività della Malattia Minima Residua (MRD) dopo consolidamento con loncastuximab tesirine.
    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: Biological sub-study on minimal residual disease (MRD) optional for patients (the description of this substudy is included in the main study protocol V. 1 22 June 2021)

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio biologico sulla malattia minima residua (MRD) opzionale per il paziente (la descrizione del sottostudio è compresa nel protocollo principale V.1 del 22/06/2021)
    E.3Principal inclusion criteria
    1) Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification;
    2) Age >= 18 and < 80 years;
    3) Relapsed/Refractory disease after one, two or three lines of treatment;
    4) Bendamustine-naive or relapsed after at least two years after the last cycle of a bendamustine-containing regimen;
    5) Previous treatment with BTKi monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment;
    6) Venetoclax treated patients are allowed;
    7) Stem cell transplant eligible patients are allowed;
    8) Measurable nodal or extranodal disease >= 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions.
    9) ECOG/WHO performance status <= 2 (unless MCL-related);
    10) Adequate liver, renal and bone marrow function, assessed by baseline laboratory values as indicated in the protocol;
    11) Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures;
    12) Subject must be able to adhere to the study visit schedule and other protocol requirements;
    13) Life expectancy >= 3 months;
    14) Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and at least 16 weeks after last loncastuximab tesirine (ADCT-402) dose.
    1) Diagnosi confermata istologicamente di MCL secondo l’edizione 2017 della classificazione della World Health Organization (WHO);
    2) Età >= 18 e < 80 anni;
    3) Malattia ricaduta/refrattaria dopo una, due o tre line di trattamento;
    4) Pazienti vergini da trattamento con bendamustina o ricaduti dopo almeno 2 anni dall’ultimo ciclo di terapia con regimi contenenti bendamustina;
    5) Precedente trattamento con BTKi in monoterapia o regimi contenenti BTKi cui sia seguita ricaduta o refrattarietà di malattia; pazienti che abbiano interrotto un trattamento con BTKi in monoterapia o in combinazione a causa di un evento avverso ma che siano in malattia attiva in necessità di trattamento;
    6) Pazienti trattati con venetoclax sono ammessi in studio;
    7) Pazienti eleggibili a trapianto di cellule staminali sono ammessi in studio;
    8) Presenza di malattia nodale o extranodale misurabile con diametro maggiore >= 1.5 cm e misurabili in 2 dimensioni perpendicolari;
    9) ECOG/WHO performance status <= 2 (a meno che dovuto al MCL);
    10) Adeguata funzionalità epatica, renale e del midollo osseo, valutata dai valori di laboratorio basali come indicato nel protocollo;
    11) Il soggetto comprende e firma volontariamente un modulo di consenso informato approvato da un Comitato Etico Indipendente (IEC), prima dell'inizio di qualsiasi procedura di screening o specifica per lo studio; 12) Il soggetto deve essere in grado di aderire al programma delle visite dello studio e agli altri requisiti del protocollo;
    13) Aspettativa di vita >= 3 mesi;
    14) Le donne in età fertile (WOCBP) e gli uomini devono accettare di usare una contraccezione efficace se sessualmente attivi. Questo vale per il periodo di tempo tra la firma del modulo di consenso informato e almeno 16 settimane dopo l'ultima dose di loncastuximab tesirine (ADCT-402).
    E.4Principal exclusion criteria
    1) Subjects who have received a bendamustine containing regimen and relapsed less than two years after the end of treatment;
    2) Known history of hypersensitivity to human antibodies;
    3) Allogenic stem cell transplant within 6 months prior to start of first study drug;
    4) Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease;
    5) Previous treatment with CD19 targeting agents;
    6) More than three lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy);
    7) Active second malignancy in the last three years other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or any other tumor that the Sponsor and Coordinating Investigator agree and document should not be considered preclusive to participate in the study;
    8) Major surgery or any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to start of study drug (R-BAC).
    9) Cardiovascular disease (NYHA class =2);
    10) Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;
    11) Evidence of other clinically significant uncontrolled condition(s) as specified in protocol;
    1) Soggetti che abbiano ricevuto regimi contenenti bendamustina e ricaduti meno di 2 anni dal termine del trattamento;
    2) Storia nota di ipersensibilità agli anticorpi di origine umana;
    3) Trapianto allogenico di cellule staminali eseguito meno di 6 mesi prima dell’inizio del trattamento in studio;
    4) Trapianto allogenico di cellule staminali con malattia del trapianto contro l'ospite (graft-versus-host disease) attiva o incontrollata;
    5) Precedente trattamento con agenti targeting del CD19;
    6) Più di tre linee precedenti di trattamento (il trapianto di cellule staminali autologo eseguito a consolidamento di una precedente line di terapia NON deve essere conteggiato come una linea di terapia);
    7) Neoplasia secondaria attiva negli ultimi 3 anni, diversa da tumori della cute non-melanomatosi, tumore alla prostata non metastatico, tumore in situ della cervice uterina, carcinoma della mammella duttale o lobulare in situ o da altri tumori che lo Sponsor e/o il Coordinatore dello studio abbiano concordato e documentato non essere preclusivi per partecipare allo studio;
    8) Interventi di chirurgia maggiore o qualsiasi tipo di terapia antitumorale inclusi chemioterapia, immunoterapia, radioterapia, terapia sperimentale compresi agenti target a piccola molecola, nei 14 giorni precedenti la somministrazione della prima dose del trattamento in studio (R-BAC).
    9) Malattie cardiovascolari (classe NYHA =2);
    10) Anamnesi di patologie rilevanti di tipo neurologico, psichiatrico, endocrinologico, metabolico, immunologico o epatico che potrebbero precludere la partecipazione allo studio o compromettere la capacità del paziente di fornire un consenso informato;
    11) Evidenza di altre condizioni clinicamente significative non controllate, come specificato nel protocollo;
    E.5 End points
    E.5.1Primary end point(s)
    12-month Progression-Free Survival (PFS). PFS will be assessed on an ITT (Intention to Treat) basis.
    Sopravvivenza libera da progressione (PFS) a 12 mesi. La PFS verrà valutata con analisi ITT (Intention To Treat).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time between the date of enrollment and the first documentation of recurrence, progression or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date.
    Tempo tra la data di arruolamento e la prima documentazione di ricaduta, progressione o morte per qualsiasi causa. I pazienti responsivi e quelli persi al follow-up verranno censorati alla data dell’ultima valutazione.
    E.5.2Secondary end point(s)
    Overall survival (OS); Rate of conversion from partial response to complete response (PR to CR) and from stable disease (SD) to PR/CR rate; Overall Response Rate (ORR), CR, PR and SD rate; Duration of Response (DOR); Event-Free Survival (EFS); MRD negativity rate; Rate of Adverse Events
    Sopravvivenza globale (OS); Rata di conversione da risposta parziale a completa (da PR a CR) e da malattia stabile (SD) a PR/CR; Tasso di risposta globale (ORR), di CR, PR e SD; Durata della risposta (DOR); Sopravvivenza libera da eventi (EFS); Tasso di negatività della MRD; Percentuale di eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date. Analysis will be on an ITT basis.; Assessed by comparing responses prior to and after loncastuximab tesirine; Defined according to Lugano 2014 criteria. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.; Defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria. Analysis will be on an ITT basis.; Defined as the time from start of treatment to disease progression, death, or discontinuation
    Tempo tra l’inizio del trattamento e la morte per qualsiasi causa; i pazienti persi al folow-up verranno censorati alla data dell’ultima valutazione. L’analisi sarà di tipo ITT.; Valutata comparando i tassi di risposta prima e dopo la somministrazione di loncastuximab tesirine.; Definiti in accordo ai criteri di Lugano 2014. La migliore risposta globale sarà definita come la migliore risposta ottenuta tra la data di inizio della terapia e l'ultimo restaging. I pazienti senza valutazione della risposta (per qualsiasi motivo) saranno considerati come non rispondenti; Definita come il tempo dalla prima documentazione di risposta del linfoma (CR/PR) alla progressione o morte secondo i criteri di Lugano 2014. L’analisi sarà di tipo ITT.; Definita come il tempo tra l’inizio del trattamento e pro
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Studio prospettico, multicentrico, di fase II a braccio singolo
    Prospective, multicenter, phase II single arm study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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)
    Not specified in the protocol. At the discretion of the Investigator according to clinical practice
    Non specificati nel protocollo. A discrezione del medico secondo pratica clinica
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 08:48:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA