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    Summary
    EudraCT Number:2019-003451-11
    Sponsor's Protocol Code Number:TP0006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003451-11
    A.3Full title of the trial
    A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
    Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con trombocitopenia immune primaria (ITP) persistente o cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)
    Studio per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con trombocitopenia immune primaria persistente o cronica ( ITP)
    A.3.2Name or abbreviated title of the trial where available
    myOpportunITy2
    myOpportunITy2
    A.4.1Sponsor's protocol code numberTP0006
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number00000000
    B.5.5Fax number00000000
    B.5.6E-mailclinicaltrials@ucb.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2131
    D.3 Description of the IMP
    D.3.1Product nameRozanolixizumab
    D.3.2Product code [UCB7665]
    D.3.4Pharmaceutical form 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 INNROZANOLIXIZUMAB
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB187374
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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
    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
    Primary Immune Thrombocytopenia
    trombocitopenia immune primaria
    E.1.1.1Medical condition in easily understood language
    Primary immune thrombocytopenia is a autoimmune disease which is characterized by an isolated low platelet count (thrombocytopenia) and the absence of other causes of thrombocytopenia.
    La trombocitopenia immunitaria primaria è una malattia autoimmune che è caratterizzata da una conta piastrinica bassa isolata (trombocitopenia) e dall'assenza di altre cause di trombocitopenia.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term Thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary immune thrombocytopenia (ITP)
    Dimostrare l’efficacia clinica di rozanolixizumab in trattamento di mantenimento nei partecipanti allo studio con ITP primaria
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerability of rozanolixizumab
    • Valutare la sicurezza e la tollerabilità di rozanolixizumab
    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: Please refer to section 8.8.1 Pharmacogenomics of the protocol TP0006 ver final dated 19 Nov 2019

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Si faccia riferimento alla sezione 8.8.1 Pharmacogenomics del protocollo TP0006 ver finale del 19 Nov 2019
    E.3Principal inclusion criteria
    -Study participant must be >=18 years of age at the time of the Screening Visit
    -Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit
    -Study participant has documented intolerance or insufficient response to one or more appropriate courses of standard of care ITP medication prior to Screening
    -Study participants must have prior history of a response to a previous ITP therapy
    -If taking allowed immunosuppressive drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1)
    -Study participant has a documented history of low platelet count (<30x10^9/L) prior to Screening
    -Study participant has a platelet count measurement at Screening and at Baseline (Day 1) with an average of the two <30x10^9/L and no single count may be >35x10^9/L (using local laboratories)
    -Study participant has a current or history of a peripheral blood smear consistent with ITP
    -Study participants may be male or female:
    a. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
    b. A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test or not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:
    Not a woman of childbearing potential (WOCBP)
    OR
    A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the dose of study treatment
    -Il partecipante allo studio deve avere un'età >=18 anni al momento della visita di Screening
    -Il partecipante allo studio ha una diagnosi di trombocitopenia immune primaria (ITP) persistente ( durata > 3 mesi) o cronica (durata > di 12 mesi) alla visita di screening
    -Il partecipante allo studio ha documentata intolleranza o risposta insufficiente a uno o più appropriati farmaci standard di cura per ITP prima dello screening
    -I partecipanti allo studio devono avere storia di una risposta a una precedenteTerapia ITP
    -Se si assumono farmaci immunosoppressori consentiti, il partecipante deve assumere dosi stabili durante periodi di tempo definiti prima del basale (giorno 1)
    -Il partecipante allo studio ha una storia documentata di bassa conta piastrinica (<30x10 ^ 9 / L) prima dello screening
    -Il partecipante allo studio ha una misurazione del conteggio piastrinico allo screening e al baseline (giorno 1) con una media dei due <30x10 ^ 9 / L e nessun singolo conteggio può essere> 35x10 ^ 9 / L (utilizzando laboratori locali)
    -Il partecipante allo studio ha un attuale o una storia di striscio di sangue periferico coerente con ITP
    -I partecipanti allo studio possono essere maschi o femmine:
    a. Un partecipante di sesso maschile deve accettare di usare la contraccezione durante il periodo di trattamento e per almeno 3 mesi dopo la dose finale del trattamento e astenersi dal donare lo sperma durante questo periodo
    b. Una donna è può partecipare allo studio se non è incinta; confermato da un test del siero di gravidanza negativo o che non prevede di rimanere incinta durante la partecipazione , non deve allattare ed almeno una delle seguenti condizioni si deve applicare:
    non una donna in età fertile (WOCBP)
    o
    Un WOCBP che accetta di seguire le lineeguida sulla contraccezione durante il periodo di trattamento e per almeno 3 mesi dopo l'ultima dose del trattamento in studio
    E.4Principal exclusion criteria
    -Participant has a history of arterial or venous thromboembolism (eg, stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment
    -Study participant has clinically significant bleeding that warrants immediate platelet adjustment (eg, menorrhagia with significant drop in hemoglobin)
    -Study participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs (and/or an investigational device) as stated in this protocol
    -Study participant has evidence of a secondary cause of immune thrombocytopenia from the past medical history (eg, bacterial or viral infection, past medical history of leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease) or to drug treatments (eg, heparin, quinine, antimicrobials,
    anticonvulsants) or participant has a multiple immune cytopenia, eg, Evan's syndrome
    -Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the dose of IMP
    -Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) -Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant -Study participant has experienced intracranial bleed in the last 6
    months prior to the Screening Visit
    -Study participant has a history of coagulopathy disorders other than ITP
    -Study participant has a Karnofsky Performance Status rating <60% at the Screening Visit
    -Study participant with current or medical history of immunoglobulin A (IgA) deficiency, or a measurement of IgA <50 mg/dL at the Screening Visit
    -Study participant has undergone a splenectomy in the 2 years prior to the Baseline Visit
    -Il partecipante ha una storia di tromboembolia arteriosa o venosa (ad es. ictus, attacco ischemico transitorio, infarto del miocardio, vena profonda trombosi o embolia polmonare) nei 6 mesi precedenti la randomizzazione o richiede un trattamento anticoagulante
    -I partecipanti allo studio hanno sanguinamenti clinicamente significativi che meritano aggiustamento piastrinico immediato (p. es., menorragia con calo significativo emoglobina)
    -Il partecipante allo studio ha un'ipersensibilità nota a qualsiasi componente del medicinale sperimentale (IMP) o farmaci comparativi (e / o un dispositivo sperimentale) come indicato nel presente protocollo
    -Il partecipante allo studio ha evidenze di una causa secondaria di trombocitopenia immune nella sua storia medica passata (ad es. infezione batterica o virale, storia medica pregressa di leucemia, linfoma, immunodeficienza variabile comune lupus eritematoso sistemico, malattia autoimmune della tiroide ) o ai trattamenti farmacologici (ad es. eparina, chinino, antimicrobici,anticonvulsivanti) o ha una citopenia immunitaria multipla, ad es.Sindrome di Evan
    -Il partecipante allo studio ha un'infezione attiva clinicamente rilevante (ad es. Sepsi,polmonite o ascesso) secondo l'opinione dello sperimentatore, o aveva uninfezione grave (con conseguente ricovero in ospedale o che richiede un trattamento antibiotico parenterale) entro 6 settimane prima della dose del farmaco sperimentale
    - Il partecipante allo studio ha un'infezione nota da tubercolosi (TB), ad alto rischio di acquisizione di infezione da tubercolosi o infezione da tubercolosi latente (LTBI) o ha attuale / storia di infezione da micobatteri non tubercolari (NTMBI)
    -Il partecipante allo studio ha una storia di un trapianto di organo maggiore o trapianto di cellule staminali / midollo ematopoietico
    -I partecipanti allo studio hanno avuto sanguinamenti intracranici negli ultimi 6 mesi prima della visita di screening
    -I partecipanti allo studio hanno una storia di disturbi della coagulopatia diversi dall'ITP
    -Il partecipante allo studio ha una valutazione dello stato delle prestazioni Karnofsky <60% alla visita di screening
    - Il partecipante allo studio ha anamnesi attuale o medica di deficit di immunoglobulina A (IgA) o una misurazione di IgA <50 mg / dL allo screening
    -Il partecipante allo studio ha subito una splenectomia nei 2 anni precedenti la visita di basale
    E.5 End points
    E.5.1Primary end point(s)
    Durable Clinically Meaningful Platelet Response of >=50x10^9/L during the last 12 weeks
    Risposta piastrinica duratura clinicamente significativa >=50x10^9/L, durante le ultime 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last 12 weeks (Week 13 to Week 25
    Durante le ultime 12 settimane ( dalla settimana 13 alla 25)
    E.5.2Secondary end point(s)
    1. Cumulative number of visits with Clinically Meaningful Platelet Response of >=50x10^9/L
    2. Response defined as platelet count >=30x10^9/L and at least a 2-fold increase of the Baseline count confirmed on at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit
    3. Complete Response defined as platelet count >=100x10^9/L confirmed on at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit
    4. Time to Clinically Meaningful Platelet Response of >=50x10^9/L: time from starting treatment to achievement of first response of >=50x10^9/L
    5. Clinically Meaningful Platelet Response of >=50x10^9/L by Day 8 6. Time to first rescue therapy
    7. Response defined as change from Baseline at or above the defined threshold for ITP Patient Assessment Questionnaire (ITPPAQ) Symptoms Score
    8. Occurrence of treatment-emergent adverse events (TEAEs)
    9. Occurrence of TEAEs leading to withdrawal of investigational medicinal product (IMP)
    - Numero cumulativo di visite con risposta piastrinica clinicamente significativa >=50x10^9/L
    - Risposta definita come conta piastrinica > =30x10^9/L e almeno raddoppiata rispetto al Basale confermata in almeno 2 occasioni separate in due visite nominali adiacenti a distanza di almeno 7 giorni e assenza di sanguinamento in ciascuna visita
    -Risposta completa definita come conta piastrinica >=100x10^9/L confermata in almeno 2 occasioni separate in due visite nominali adiacenti ad almeno 7 giorni di distanza e assenza di sanguinamento in ciascuna visita
    - Tempo alla risposta piastrinica clinicamente significativa >=50x10^9/L: tempo dall’inizio del trattamento al raggiungimento della prima risposta >=50x10^9/L
    - Risposta piastrinica clinicamente significativa >=50x10^9/L entro il Giorno 8
    - Tempo alla prima somministrazione della terapia di emergenza
    - Risposta definita come variazione dal Basale a un livello pari o superiore alla soglia definita per il punteggio relativo ai sintomi del questionario ITP-PAQ (ITP Patient Assessment Questionnaire)
    - Manifestarsi di eventi avversi durante il trattamento (TEAE)
    - Manifestarsi di TEAE che portano all’interruzione del medicinale sperimentale (IMP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 2.; 3. and 7. From Baseline during Treatment Period (up to Week 25)
    4. Time from starting treatment to achievement of first response of >= 50x10^9/L (up to Week 25)
    5. Baseline to Day 8
    6. From Baseline to first rescue therapy (up to Week 25)
    8. and 9. From Baseline to end of Safety Follow-Up Period (up to Week 31)
    1 .; 2 .; 3. e 7. Dal basale durante il periodo di trattamento (fino alla settimana 25)
    4. Tempo trascorso dall'inizio del trattamento al raggiungimento della prima risposta >=50x10 ^ 9 / L (fino alla settimana 25)
    5. Dal baseline al giorno 8
    6. Dal basale alla prima terapia di salvataggio (fino alla settimana 25)
    8. e 9. Dal basale alla fine del periodo di follow-up di sicurezza (fino alla settimana 31)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    Tollerabilità, Immunogenicità
    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 EEA40
    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
    Canada
    China
    Hong Kong
    Japan
    Russian Federation
    Taiwan
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    United Kingdom
    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 visit of the last subject (LVLS)
    Ultima visita dell'ultimo soggetto ( 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 months1
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 105
    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)
    Eligible study participants will be given the opportunity to enroll into the open-label extension (OLE) study, TP0004.
    I partecipanti allo studio eligibili avranno la possibilità di entrare nello studio di estensione in aperto (OLE), TP0004.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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