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    Summary
    EudraCT Number:2014-004632-19
    Sponsor's Protocol Code Number:D3461C00004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-004632-19
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y seguridad de anifrolumab en pacientes adultos con lupus eritematoso sistémico activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus
    Estudio para evaluar la eficacia y seguridad de anifrolumab comparado con placebo
    en pacientes adultos con lupus eritematoso sistémico activo
    A.4.1Sponsor's protocol code numberD3461C00004
    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.1.3.4CountryUnited Kingdom
    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 AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@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 nameAnifrolumab
    D.3.4Pharmaceutical form 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 INNAnifrolumab
    D.3.9.2Current sponsor codeMEDI-546
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    Lupus eritomatoso sistémico
    E.1.1.1Medical condition in easily understood language
    Lupus, an autoimmune disease
    Lupus y enfermedad autoinmune
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of anifrolumab compared to placebo on disease activity as
    measured by the difference in the proportion of subjects who achieve an SLE Responder Index of ?4 (SRI[4]) at Week 52
    Evaluar el efecto de anifrolumab en comparación con placebo sobre la actividad de la enfermedad, medida por la diferencia en la proporción de pacientes que alcanzan un Índice de Respuesta del LES ?4 (SRI[4]) en la semana 52.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of anifrolumab compared to placebo on:
    a. The proportion of subjects with SRI(4) at Week 52 in the IFN test-high sub-group
    b. The proportion of subjects who achieve an OCS dose ?7.5 mg/day at Week 40, which is maintained through Week 52 in the sub-group of subjects with baseline OCS ?10 mg/day
    c. The proportion of subjects with a ?50% reduction in CLASI activity score at Week 12 in the sub-group of subjects with baseline CLASI activity score ?10
    d. The proportion of subjects with SRI(4) at Week 24
    e. The annualised flare rate through 52 weeks
    2. To evaluate the safety and tolerability of anifrolumab
    1.Evaluar el efecto de anifrolumab en comparación con placebo sobre lo siguiente:
    a.La proporción de pacientes con SRI(4) en la semana 52, en el subgrupo con un resultado alto en el análisis de IFN.
    b.La proporción de pacientes que alcanzan una dosis de CEO ?7,5 mg/día en la semana 40 y la mantienen hasta la semana 52, en el subgrupo de pacientes con CEO iniciales ?10 mg/día.
    c.La proporción de pacientes con una reducción ?50 % en la puntuación de la actividad del Área e Índice de Gravedad del Lupus Eritematoso Cutáneo (CLASI) en la semana 12, en el subgrupo de pacientes con puntuación CLASI inicial ?10.
    d.La proporción de pacientes con SRI(4) en la semana 24.
    e.La tasa anual de exacerbaciones durante 52 semanas.
    2.Evaluar la seguridad y tolerabilidad de anifrolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 through 70 years at the time of screening
    2. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982 revised criteria (Tan et al, 1982) ?24 weeks prior to signing the Informed Consent form (ICF)
    3. Currently receiving at least 1 of the following:
    (a) A dose of oral prednisone (?40 mg/day) for a minimum of 2 weeks prior to signing of the ICF.
    (b) Any of the following medications administered for a minimum of 12 weeks prior to signing the informed consent, and at a stable dose for a minimum of 8 weeks prior to signing the informed consent and until Day 1:
    (i) Azathioprine?200 mg/day
    (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
    (iii) Mycophenolate mofetil?2 g/day or mycophenolic acid ?1.44 g/day
    (iv) Oral, subcutaneous (SC), or intramuscular methotrexate?25 mg/week
    (v) Mizoribine ?150 mg/day
    4. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for SLE, at least 1 of which must be:
    (a) Positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at the central laboratory with titre ?1:80; OR
    (b) Elevated anti-dsDNA antibodies OR anti-Smith (anti-Sm) antibody at screening as determined by the central laboratory
    5. At Screening, Disease Activity Adjudication Group confirmation of:
    SLEDAI-2K Criteria: SLEDAI-2K score ?6 points and (Clinical)SLEDAI-2K score ?4 points. The (Clinical) SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures:
    6. Must not have active or latent TB on either chest radiograph or by quantiferon gold test
    7. Day 1 (Clinical) SLEDAI-2K score ?4 points
    8. OCS dose stable for at least 2 weeks
    9. Stable SLE SOC treatment
    10. Women of child-bearing potential must have a negative serum ?-hCG test at screening and negative urine pregnancy test prior to administration of investigational product
    1.Edad entre 18 y 70 años en el momento de la selección.
    2.Diagnóstico de LES pediátrico o adulto conforme a los criterios revisados del ACR de 1982 (Tan et al, 1982) ?24 semanas antes de la firma del FCI.
    3.Actualmente en tratamiento con al menos 1 de los siguientes fármacos:
    (a)Una dosis de prednisona oral (?40 mg/día) durante un mínimo de 2 semanas antes de la firma del FCI. La dosis de prednisona oral que recibe el paciente debe ser estable durante un mínimo de 2 semanas antes de la semana 0 (día 1).
    (b)Cualquiera de los siguientes medicamentos administrados durante un mínimo de 12 semanas antes de la firma del consentimiento informado, y a una dosis estable durante un mínimo de 8 semanas antes de la firma del consentimiento informado y hasta el día 1:
    (i) Azatioprina ?200 mg/día.
    (ii) Antipalúdicos (p. ej., cloroquina, hidroxicloroquina, mepacrina).
    (iii) Micofenolato de mofetilo ?2 g/día o ácido micofenólico?1,44 g/día.
    (iv) Metotrexato?25 mg/semana por vía oral, subcutánea (s.c.) o intramuscular.
    (v) Mizoribina ?150 mg/día.
    4.Cumplimiento de al menos 4 de los 11 criterios modificados de clasificación del LES de 1982 elaborados por el ACR (ver el Anexo D), y al menos 1 de ellos tiene que ser:
    (a) Presencia de anticuerpos antinucleares (ANA) en la selección, detectados por análisis de inmunofluorescencia (AIF) en el laboratorio central, con un título ?1:80; O
    (b) Anticuerpos anti-ADNbc O anticuerpos anti-Smith (anti-Sm) elevados en la selección, según la determinación del laboratorio central.
    5.En la selección, confirmación por el Grupo de adjudicación de actividad de la enfermedad de:
    Criterios relativos al SLEDAI-2K: puntuación SLEDAI-2K ?6 puntos y puntuación SLEDAI-2K «clínico» ?4 puntos. El SLEDAI-2K «clínico» es la puntuación en la evaluación SLEDAI-2K sin incluir los puntos atribuibles a resultados de análisis en orina o de laboratorio, incluidas las determinaciones inmunológicas:
    6.Sin antecedentes de TB activa o latente antes de la selección ni en Radiografía torácicani en la prueba de detección de TB QuantiFERON-TB Gold
    7.Puntuación SLEDAI-2K «clínico» en el día 1 ?4 puntos.
    8.Dosis de CEO estable durante al menos 2 semanas.
    9.Tratamiento de referencia estable para el LES
    10.Mujeres con capacidad de concebir deben tener resultado negativo en el análisis en suero de la gonadotropina coriónica humana-? (? -hCG) en la selección y deben dar negativo en una prueba de embarazo en orina antes de la administración del producto en investigación.
    E.4Principal exclusion criteria
    1. Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
    2. Receipt of any of the following:
    (a) Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks
    prior to Day 1
    3. History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome. 4. Active severe or unstable neuropsychiatric SLE
    5. Active severe SLE-driven renal disease
    6. Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any history of overlap syndromes of SLE or SSc.
    7. History of, or current, inflammatory joint or skin disease other than SLE
    8. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the 24 weeks prior to enrollment
    9. Confirmed positive test for hepatitis B or hepatitis C
    10. Any severe herpes infection at any time prior to Week 0 (Day 1)
    11. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization
    12. History of cancer, apart from:
    (a) Squamous or basal cell carcinoma of the skin that has been successfully treated
    (b) Cervical cancer in situ that has been successfully treated
    1.Administración de algún producto en investigación (molécula pequeña o fármaco biológico) en las 4 semanas o las 5 semividas previas a la firma del FCI, el plazo que sea mayor
    2.Administración de alguno de los siguientes fármacos:
    (a)Glucocorticoesteroides por vía i.v., intramuscular o intraarticular en las 6 semanas anteriores al día 1.
    3.Antecedentes o diagnóstico actual de un síndrome de vasculitis de importancia clínica no relacionado con el LES
    4.LES neuropsiquiátrico activo grave o inestable
    5.Nefropatía grave activa dirigida por el LES
    6.Diagnóstico (en el plazo de 1 año antes de la firma del FCI) de enfermedad mixta del tejido conjuntivo o cualquier antecedente de síndromes mixtos del tejido conjuntivo de LES o esclerosis sistémica
    7.Dermopatías o artropatías inflamatorias en curso aparte del LES
    8.Antecedentes de alguna enfermedad aparte del LES que haya requerido tratamiento con corticoesteroides por vía oral o parenteral durante más de un total de 2 semanas en las últimas 24 semanas antes de la firma del FCI.
    9.Resultado positivo confirmado en las siguientes pruebas serológicas de hepatitis B o C
    10.Alguna infección herpética grave en algún momento antes de la semana 0 (día 1)
    11.Infección oportunista que requirió hospitalización o tratamiento antibiótico por vía parenteral en los 3 años previos a la aleatorización.
    12.Antecedentes de cáncer, a excepción de los siguientes:
    (a)Carcinoma basocelular o espinocelular tratado y con éxito
    (b)Carcinoma cervicouterino localizado tratado y con éxito
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in proportions of subjects achieving Systemic Lupus Erythematosus Responder Index SRI(4) at Week 52 comparing anifrolumab 300 mg to placebo.
    El objetivo prncipal es la diferencia en la proporción de pacientes que alcanzan un Índice de Respuesta del LES SRI(4) en la semana 52, de anifrolumab 300 mg en comparación con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    1a. The composite endpoint SRI4 will be the measure of this objective.
    1b. Maintained OCS reduction defined by the following criteria:
    - Achieve an OCS dose of ?7.5 mg/day prednisone or equivalent by Week 40 and
    - Maintain an OCS dose ?7.5 mg/day prednisone or equivalent from Week 40 to Week 52 and
    - No discontinuation of investigational product or use of restricted medications beyond the protocol-allowed threshold before assessment
    1c. 50% reduction in CLASI activity score compared to baseline defined by the following criteria:
    - Achieve ?50% reduction of CLASI activity score at Week 12 compared to baseline and
    - No discontinuation of investigational product or use of restricted medications beyond the protocol-allowed threshold before assessment
    1d. The composite endpoint SRI4 will be the measure of this objective
    1e. Annualised flare rate with flare defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit
    2. The following safety data will be collected: vital signs, physical examination, 12-lead ECG, haematology, clinical chemistry, urinalysis, CSSRS, PHQ-8, modified SLEDAI Flare Index based flares, and reported AEs
    1a.El objetivo compuesto SRI(4), será Criterio de valoración de este objetivo.
    1b.Reducción mantenida de los CEO, definida por los siguientes criterios:
    -consecución de una dosis de CEO ?7,5 mg/día de prednisona o equivalente para la semana 40
    -mantenimiento de una dosis de CEO ?7,5 mg/día de prednisona o equivalente desde la semana 40 hasta la semana 52 y
    -sin interrupción de la administración del producto en investigación ni utilización de medicamentos restringidos más allá del límite permitido por el protocoloa antes de la evaluación.
    1c. Reducción del 50 % en la puntuación de la actividad CLASI en comparación con el valor inicial, definida por los siguientes criterios:
    -consecución de una reducción ?50 % en la puntuación de la actividad CLASI en la semana 12 en comparación con el valor inicial y
    -sin interrupción de la administración del producto en investigación ni utilización de medicamentos restringidos más allá del límite permitido por el protocoloa antes de la evaluación.
    1d.El objetivo compuesto SRI(4), será Criterio de valoración de este objetivo.
    1e. Tasa anual de exacerbaciones, donde «exacerbación» se define como 1 o más ítems nuevos en el BILAG-2004 A o 2 o más ítems nuevos en el BILAG-2004 B, en comparación con la visita anterior.
    2. Se recogerán los siguientes datos de seguridad: constantes vitales, exploración física, electrocardiogramas de 12 derivaciones, exacerbaciones basadas en el índice de exacerbaciones SLEDAI modificado, análisis clínicos (hematología, bioquímica clínica y análisis de orina), escala de Columbia para evaluar la gravedad de las conductas suicidas y escala de depresión del cuestionario de salud del paciente de 8 ítems, y los acontecimientos Adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1a. - Week 52
    1b. - Week 52
    1c. - Week 12
    1d. - Week 24
    1e. - Weeks 0- 52
    2. Weeks 0-52
    1a. - Semana 52
    1b. - Semana 52
    1c. - Semana 12
    1d. - Semana 24
    1e. - Semanas 0- 52
    2. Semanas 0-52
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Korea, Republic of
    Lithuania
    Mexico
    Russian Federation
    Singapore
    South Africa
    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
    LPLV
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who participate in this study may have the option of entering a separate long-term extension study, if eligible.
    Los sujetos que participen en este ensayo deberán tener la posibidad de participar en el estudio de extension de tratamiento a largo plazo, si son elegidos.
    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 Decision2015-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-06
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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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