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    Summary
    EudraCT Number:2017-001748-36
    Sponsor's Protocol Code Number:GCT3013-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-06
    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 number2017-001748-36
    A.3Full title of the trial
    A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    Studio di fase 1/2, in aperto, con aumento progressivo della dose di GEN3013 in pazienti con linfoma a cellule B recidivante, progressivo o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    Studio di fase 1/2, in aperto, con aumento progressivo della dose di GEN3013 in pazienti con linfoma a cellule B recidivante, progressivo o refrattario
    A.3.2Name or abbreviated title of the trial where available
    First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    Primo studio sull'uomo (FIH, first-in-human) in pazienti con linfoma a cellule B recidivante, progre
    A.4.1Sponsor's protocol code numberGCT3013-01
    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 SponsorGENMAB A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.6E-mailregulatory@genmab.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 nameepcoritamab
    D.3.2Product code [DuoBody-CD3xCD20]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeGEN3013 (DuoBody®-CD3xDC20)
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeGEN3013 (DuoBody¿-CD3xCD20)
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed, progressive and/or refractory mature B-cell lymphoma
    Patients with:
    - Diffuse large B-cell lymphoma – de novo or transformed
    - High-grade B-cell lymphoma
    - Primary mediastinal large B-cell lymphoma
    - Follicular lymphoma
    - Mantle cell lymphoma
    - Small lymphocytic lymphoma
    - Marginal zone lymphoma (nodal, extranodal or mucosa associated)
    linfoma a cellule B recidivante, progressivo o refrattario.
    Pazienti con:
    o Linfoma diffuso a grandi cellule B (DLBCL)
    o Linfoma a cellule B ad alto grado di malignità (HGBCL)
    o Linfoma a cellule B primitivo del mediastino (PMBCL)
    o Linfoma follicolare (FL)
    o Linfoma mantellare (MCL)
    o Piccolo linfoma linfocitico (SLL)
    o Linfoma della zona marginale (MZL)
    E.1.1.1Medical condition in easily understood language
    Lymphoma of B-cell origin
    linfoma a cellule B
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    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
    Escalation Phase:
    - Determine maximum tolerated dose and recommended phase 2 dose

    Expansion Phase:
    - To evaluate clinical efficacy as determined by Lugano criteria
    Fase di aumento progressivo della dose
    - Determinare la dose massima tollerata (MTD) e la RP2D

    Fase di espansine
    - Valutare l’efficacia clinica determinata in base ai criteri di Lugano
    E.2.2Secondary objectives of the trial
    Escalation Phase:
    - Establish tolerability of GEN3013
    - Establish PK profile after single and multiple doses
    - Evaluate immunogenicity
    - Evaluate anti-lymphoma activity

    Expansion Part:
    - To further evaluate clinical efficacy as determined by Lugano criteria
    - To evaluate clinical efficacy as determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
    - To further evaluate clinical efficacy
    - To evaluate MRD status as a clinical efficacy endpoint
    - To evaluate safety and tolerability of GEN3013
    - To evaluate the PK and immunogenicity of GEN3013
    - To evaluate patient-reported outcomes (PROs) related to lymphoma symptoms
    Fase di aumento progressivo della dose
    - Stabilire la tollerabilità di GEN3013
    - Stabilire il profilo farmacocinetico (PK) dopo dosi singole e multiple
    - Valutare l’immunogenicità
    - Valutare l’attività anti-linfoma

    Fase di espansine
    - Valutare ulteriormente l’efficacia clinica determinata in base ai criteri di Lugano
    - Valutare l’efficacia clinica determinata in base a LYRIC
    - Valutare ulteriormente l’efficacia clinica
    - Valutare lo stato MRD come endpoint di efficacia clinica
    - Valutare la sicurezza e la tollerabilità di GEN3013
    - Valutare la PK e l’immunogenicità di GEN3013
    - Valutare i risultati riportati dai pazienti (PRO) relativi ai sintomi del linfoma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be 18 years of age or older
    2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification
    3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody
    4. Patients must have received at least 2 prior lines of therapy
    5. Patients must have measurable disease by imaging
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (2 for escalation)
    Per entrambe le parti dello studio, i pazienti devono avere almeno 18 anni di età, essere affetti da una neoplasia a cellule B CD20+ matura documentata secondo la classificazione OMS 2008 o 2016 sulla base di un referto patologico rappresentativo, e presentare almeno 1 sito misurabile della malattia basato su TAC/RMN.

    Per la parte di aumento progressivo della dose, i pazienti devono presentare DLBCL, HGBCL, PMBCL, FL, MCL, SLL o MZL. I pazienti devono essere affetti da malattia recidivante, progressiva e/o refrattaria.

    Per la parte di espansione, i pazienti devono presentare aNHL R/R (DLBCL, PMBCL, HGBCL, FL grado 3B) o iNHL R/R (FL grado 1-3A, MZL, SLL). I pazienti devono essere stati sottoposti ad almeno 2 precedenti linee di terapia.

    [Per l'elenco completo si veda il protocollo.]
    E.4Principal exclusion criteria
    1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
    2. AST, and/or ALT > 3 x upper limit of normal
    3. Total bilirubin > 1.5 x upper limit of normal
    4. Creatinine clearance < 45 mL/min
    5. Known clinically significant cardiac disease, including:
    a. Onset of unstable angina pectoris within 6 months of signing ICF
    b. Acute myocardial infarction within 6 months of signing ICF
    c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%
    6. Chronic ongoing infectious diseases (except hepatitis B or hepatitis C) requiring treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of GEN3013
    7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
    8. Active hepatitis B or ongoing hepatitis C infacrion that has not been cured. If laboratory evidence for a chronic infection with hepatitis B close monitoring and prophylactic therapy is required
    9. Known human immunodeficiency virus (HIV) infection
    10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
    11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration
    12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation
    13. Contraindication to all uric acid lowering agents
    I pazienti sono esclusi dalla partecipazione a qualsiasi parte dello studio se presentano linfoma primitivo a carico del sistema nervoso centrale (SNC) o coinvolgimento noto dell’SNC, neoplasia passata o attuale (eccetto quelle indicate nel protocollo), AST o ALT >3x ULN, bilirubina totale > 1,5x ULN, clearance della creatinina < 45 ml/min, malattie cardiache clinicamente significative, malattie infettive croniche in corso, malattie o trattamenti che provocano immunosoppressione o disturbi convulsivi che richiedono terapia.

    [Per l'elenco completo si veda il protocollo.]
    E.5 End points
    E.5.1Primary end point(s)
    Escalation End Points:
    - Dose limiting toxicity
    - Adverse events

    Expansion End Points:
    - Overall response rate (ORR) determined by Lugano criteria as assessed by independent review committee (IRC)
    Endpoint della fase di aumento progressivo della dose:
    ¿ Tossicità dose-limitante (DLT)
    ¿ Eventi avversi (AE)

    Endpoint della fase di espansione:
    ¿ Tasso di risposta globale (ORR) determinato in base ai criteri di Lugano e valutato da un comitato di revisione indipendente (IRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - DLT evaluation period is defined as the first 4 weeks, i.e. 28 days after the first administration of GEN3013.
    - AE evaluation will be done at each visit during the entire study
    - DLT evaluation period is defined as the first 4 weeks, i.e. 28 days after the first administration of GEN3013.
    - AE evaluation will be done at each visit during the entire study
    E.5.2Secondary end point(s)
    Escalation End Points:
    - Cytokine measures
    - Laboratory parameters (biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as T-cell activation and exhaustion markers)
    - PK parameters (clearance, volume of distribution and area-under-the concentration- time curve (AUC0-Clast and AUC0-8), maximum concentration (Cmax), time of Cmax (Tmax), pre dose values, and half-life)
    - Immunogenicity of GEN3013
    - Anti-lymphoma activity, i.e. resolution of constitutional symptoms, reduction in tumor size, objective and best response
    - Duration of response
    - Progression free survival
    - Time to next anti-lymphoma therapy
    - Overall survival

    Expansion End Points:
    - Duration of response (DOR) determined by Lugano criteria as assessed by IRC
    - Complete response (CR) rate determined by Lugano criteria as assessed by IRC
    - Progression-free survival (PFS) determined by Lugano criteria as assessed by IRC
    - Time to response (TTR) determined by Lugano criteria as assessed by IRC
    - Objective and best response rate determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) as assessed by IRC
    - PFS determined by LYRIC as assessed by IRC
    - DOR determined by LYRIC as assessed by IRC
    - TTR determined by LYRIC as assessed by IRC
    - Overall survival (OS)
    - Time to next (anti-lymphoma) therapy (TTNT)
    - MRD status by detection of cancer cell gene sequences
    - Safety (i.e., adverse events, laboratory parameters [biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as T-cell activation and exhaustion markers], hospitalizations, and cytokine measures)
    - PK parameters (clearance, volume of distribution, Cmax, Tmax, trough concentrations, and half-life) and incidence of ADAs to GEN3013
    - Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)
    Endpoint della fase di aumento progressivo della dose
    ¿ Valori delle citochine
    ¿ Parametri di laboratorio (biochimica, ematologia con immunofenotipizzazione per le conte assolute delle cellule T e delle cellule B, nonché dei marcatori di attivazione e di esaurimento delle cellule T)
    cellule B, nonché dei marcatori di attivazione e di esaurimento delle cellule T)
    ¿ Parametri PK [clearance, volume di distribuzione e area sotto la curva concentrazione-tempo (AUC0-Clast e AUC0-8), concentrazione massima (Cmax), tempo di Cmax (Tmax), valori pre-dose e emivita]
    ¿ Immunogenicità di GEN3013
    ¿ Attività anti-linfoma, ossia risoluzione dei sintomi costituzionali, riduzione delle dimensioni del tumore, risposta obiettiva e ottimale (ORR, CR e PR)
    ¿ Durata della risposta (DOR)
    ¿ Sopravvivenza libera da progressione (PFS)
    ¿ Tempo fino alla prossima terapia anti-linfoma (TTNT)
    ¿ Sopravvivenza globale (OS)

    Endpoint della fase di espansione
    ¿ DOR determinata in base ai criteri di Lugano secondo la valutazione dell’IRC
    ¿ Risposta completa (CR) determinata in base ai criteri di Lugano secondo la valutazione dell’IRC
    ¿ PFS determinata in base ai criteri di Lugano secondo la valutazione dell’IRC
    ¿ Tempo alla risposta (TTR) determinata in base ai criteri di Lugano secondo la valutazione dell’IRC
    ¿ Tasso di risposta obiettiva e ottimale determinato dalla risposta del linfoma ai criteri della terapia immunomodulante (LYRIC) valutata dall’IRC
    ¿ PFS determinata in base a LYRIC secondo la valutazione dell’IRC
    ¿ DOR determinata in base a LYRIC secondo la valutazione dell’IRC
    ¿ TTR determinata in base a LYRIC secondo la valutazione dell’IRC
    ¿ OS
    ¿ TTNT
    ¿ Stato MRD mediante rilevazione delle sequenze geniche delle cellule tumorali
    ¿ Sicurezza [ossia eventi avversi, parametri di laboratorio (biochimica, ematologia con immunofenotipizzazione per le conte assolute delle cellule T e delle cellule B, nonché dei marcatori di attivazione e di esaurimento delle cellule T), ricoveri in ospedale e valori delle citochine]
    ¿ Parametri PK (clearance, volume di distribuzione, Cmax, Tmax, concentrazioni minime e emivita) e incidenza degli ADA verso GEN3013
    ¿ Variazioni nei sintomi del linfoma misurati dalla valutazione funzionale della terapia antitumorale-linfoma (Functional Assessment of Cancer Therapy-Lymphoma, FACT-Lym)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Durante tutto lo studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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) Yes
    E.7.1.1First administration to humans Yes
    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
    E.8.1.2 -In aperto: la risposta corretta è SI
    E.8.1.2- Open : should be YES
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    Denmark
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Singapore
    Spain
    United Kingdom
    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
    The trial is considered completed with the last safety follow-up visit (4 weeks after last dose) for the last patient participating in the trial. The trial will run for a maximum of 5 years after the last patient’s first treatment.
    Lo studio sarà ritenuto concluso con l'ultimo follow-up di sicurezza (4 settimane dopo l'ultima dose) per l'ultimo soggetto partecipante nello studio. Lo studio durerà per un massimo di 5 anni dopo il primo trattamento dell'ultimo soggetto.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 347
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 248
    F.4.2.2In the whole clinical trial 386
    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)
    When a patient is no longer in the trial, further treatment is at the discretion of the patient's doctor.
    Quando un paziente esce dallo studio, i trattamenti a cui sarà sottoposto sono a discrezione del medico curante di riferimento.
    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 Decision2021-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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
    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.

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