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    Summary
    EudraCT Number:2020-002855-40
    Sponsor's Protocol Code Number:REN001-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-002855-40
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)
    ESTUDIO DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE UN TRATAMIENTO DE 24 SEMANAS CON REN001 EN PACIENTES CON MIOPATÍA MITOCONDRIAL PRIMARIA (MMP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study the effectiveness and safety of REN001 in PMM patients after 24 weeks of treatment.
    Estudiar la eficacia y seguridad de REN001 en pacientes con MMP después de 24 semanas de tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2b Safety and Efficacy Study of REN001 in Mitochondrial Myopathy
    Estudio de seguridad y eficacia de fase 2b de REN001 en la miopatía mitocondrial
    A.4.1Sponsor's protocol code numberREN001-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04535609
    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 SponsorReneo Pharma Ltd.
    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 supportReneo Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReneo Pharma Ltd
    B.5.2Functional name of contact pointLynn Purkins
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, Discovery Park,Ramsgate Road
    B.5.3.2Town/ citySandwich, Kent
    B.5.3.3Post codeCT13 9FF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401304 809360
    B.5.6E-maillpurkins@reneopharma.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/3/20/2311
    D.3 Description of the IMP
    D.3.1Product nameREN001
    D.3.2Product code REN001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREN001
    D.3.9.2Current sponsor codeREN001
    D.3.9.3Other descriptive nameSodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop-1-y-nyl)phenyl]allyloxy}-2-methylphenoxy)acetate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Mitochondrial Myopathy
    MIOPATÍA MITOCONDRIAL PRIMARIA
    E.1.1.1Medical condition in easily understood language
    group of disorders associated with changes in genetic material found within the DNA of mitochondria (mtDNA) or in genes outside the mitochondria (nuclear DNA), mainly affecting the skeletal muscle
    grupo de trastornos asociados con cambios en el material genético que se encuentran dentro del ADN de las mitocondrias (ADNmt) o en genes fuera de las mitocondrias (ADN nuclear)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027710
    E.1.2Term Mitochondrial myopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.
    Evaluar la eficacia de REN001 en sujetos con MMP tratados durante 24 semanas, evaluados por el efecto sobre la resistencia al ejercicio.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on fatigue.
    Evaluar la eficacia de REN001 en sujetos con MMP tratados durante 24 semanas, evaluados por el efecto sobre la fatiga.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects aged 18 years or older with PMM
    2. A confirmed PMM diagnosis due to known pathogenic gene mutation or deletion of the mitochondrial genome.
    3. Documented PMM primarily characterized by exercise intolerance or active muscle pain.
    4. Subjects must be ambulatory and able to perform the 12MWT independently (walking aids are allowed).
    5. Distance walked of ≤1000 meters at Screening in the 12MWT (must be obtained at least 4 weeks before randomization).
    6. Have no changes to any therapeutic exercise regimen within 30 days prior to Day 1 and be willing to remain on the same therapeutic exercise regimen for the duration of the study.
    7. Be willing and able to swallow gelatin capsules.
    8. Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening through to 30 days after last dose in the study. Males with partners who are WOCBP must also use contraception.
    9. Concomitant medications (including supplements) must be stable for at least 1 month prior to enrolment and throughout participation in the study.
    10. For subjects under 25 years of age, confirmation of bone growth plate closure by wrist radiograph
    11. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    1. Pacientes de 18 años o más con MMP
    2. Un diagnóstico confirmado de MMP debido a una mutación genética patógena conocida o a la eliminación del genoma mitocondrial.
    3. MMP documentada caracterizada principalmente por intolerancia al ejercicio o dolor muscular activo.
    4. Los sujetos deben ser ambulatorios y capaces de realizar la 12MWT de forma independiente (se permiten las ayudas para caminar).
    5. Distancia caminada ≤1000 metros en la selección en la 12MWT (debe obtenerse al menos 4 semanas antes de la aleatorización).
    6. No haber hecho cambios en ninguna pauta terapéutica de ejercicio en los 30 días anteriores al día 1 y estar dispuesto a seguir con la misma pauta terapéutica durante todo el estudio.
    7. Estar dispuesto y ser capaz de tragar cápsulas de gelatina.
    8. Las mujeres no deben estar en edad fértil o deben aceptar usar métodos anticonceptivos altamente eficaces desde la selección hasta 30 días después de la última dosis del estudio. Se aconseja utilizar un método anticonceptivo adicional no hormonal efectivo en mujeres que usen tratamiento anticonceptivo hormonal. Los hombres con parejas en edad fértil (MEF) también deben utilizar métodos anticonceptivos.
    9. Los medicamentos concomitantes (incluidos suplementos) para el tratamiento de la MMP u otras comorbilidades deben ser estables durante al menos 1 mes antes de la aleatorización y durante toda la participación en el estudio.
    10. Solo para sujetos menores de 25 años de edad: confirmación del cierre de las placas de crecimiento óseo confirmado mediante radiografía de muñeca.
    11. Constancia de un documento de consentimiento informado firmado y fechado personalmente que indique que se ha informado al sujeto de todos los aspectos pertinentes del estudio.
    E.4Principal exclusion criteria
    1. Participation in a prior REN001 study.
    2. Currently taking or anticipated to need a PPAR agonist during the study.
    3. Bone deformities or motor abnormalities other than related to the mitochondrial myopathy that may interfere with the outcome measures.
    4. Treatment with an investigational drug within 3 months or 5 drug half-lives, whichever is longer, prior to Day 1.
    5. Anticipated to need a prescription and/or non-prescription drug that might interfere with the study endpoints
    6. Currently taking drugs with a narrow therapeutic index and BCRP mediated ADME
    7. Clinically significant kidney disease or impairment with an eGFR less than 60ml/min/1.73m2 using the CKD-EPI creatinine equation at Screening.
    8. Clinically significant liver disease or impairment of AST or ALT Grade 2 or above (>2.5 x ULN), or Total bilirubin > 1.6 x ULN or >ULN with other signs and symptoms of hepatotoxicity at Screening.
    9. Uncontrolled diabetes and/or a Screening HbA1c of ≥11%.
    10. Uncontrolled epilepsy.
    11. Evidence of significant concomitant clinical disease that may need a change in management during the study or could interfere with the conduct or safety of this study.
    12. A history of cancer. A history of in situ basal cell carcinoma in the skin is allowed.
    13. Have been hospitalized within the 3 months prior to Screening for any major medical condition (as deemed by the Investigator).
    14. Clinically significant cardiac disease and/or clinically significant ECG abnormalities including a screening QTcF of ≥ 450 msec, 2nd degree heart block, symptomatic tachyarrhythmia or unstable arrythmia that in the opinion of the Investigator should exclude the subject from completing exercise tests (i.e. study 12 MWT and 30 STS tests).
    15. Any condition possibly reducing drug absorption.
    16. Evidence of hospitalization for rhabdomyolysis within the year prior to enrolment.
    17. Positive HBsAg, HBcAb or hepatitis C or HIV at Screening.
    18. Pregnant or nursing females.
    19. History of sensitivity to PPAR agonists.
    20. Donation or intent to donate blood, or blood components during the study or within one month after completion of the study.
    21. A history of drug dependency. Use of opiates/cannabis for medical reasons is acceptable with prescription evidence or at the Investigators discretion.
    22. A history of alcohol dependency.
    23. Significant impairment due to central or peripheral nervous system involvement that would interfere with the exercise tests.
    24. Significant weakness not caused by the underlying primary muscle disease such as post stroke or neurogenic weakness.
    25. Have had an organ transplant.
    26. Are not eligible or have a contraindication for cataract surgery.
    27. A history of osteoporosis as evidenced by non-traumatic (stress) fractures or a prior T-score of -2.5 or worse which has not been adequately addressed.
    28. Inability to comprehend or unwilling to follow the study requirements including restrictions on treatments, attendance at the study center, completion of questionnaires and participation in laboratory testing as called for by the protocol.
    29. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator and in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study.
    1. Participación en un estudio previo de REN001.
    2. Necesidad actual o previsión de necesitar un agonista del receptor activado por proliferadores de peroxisomas (peroxisome proliferator-activated receptor, PPAR) durante el estudio.
    3. Deformidades óseas o anomalías motoras distintas de aquellas relacionadas con la miopatía mitocondrial que puedan interferir con las medidas de los resultados.
    4. Tratamiento con un fármaco en investigación en los 3 meses o 5 semividas del fármaco, lo que sea más largo, antes del día 1.
    5. Se prevé que necesite un fármaco con y/o sin receta que pudiera interferir en los criterios de valoración del estudio.
    6. Actualmente toma fármacos con un índice terapéutico estrecho y de absorción, distribución, metabolismo y excreción (ADME) mediadas por la proteína de resistencia al cáncer de mama (Breast Cancer Resistance Protein, BCRP)
    7. Enfermedad o disfunción renal clínicamente significativa, con un índice de filtración glomerular estimado (TFGe) menor de 60 ml/min/1,73m2 mediante la ecuación de creatinina de la Colaboración Epidemiológica de la Enfermedad Renal Crónica (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI) en la selección.
    8. Enfermedad hepática clínicamente significativa o deterioro con aspartato aminotransferasa (AST) o de la alanina aminotransferasa (ALT) >2,5 veces el límite superior de la normalidad (LSN) o bilirrubina total >1,6 veces el LSN o >LSN con otros signos y síntomas de hepatotoxicidad en la selección.
    9. Diabetes no controlada y/o una hemoglobina glucosilada (HbA1c) en la selección ≥11 %.
    10. Epilepsia no controlada.
    11. Evidencia de enfermedad clínica concomitante significativa que pueda requerir un cambio en el manejo durante el estudio o que pudiera interferir en la realización o la seguridad de este estudio.
    12. Antecedentes de cáncer. Se admiten sujetos con antecedentes de carcinoma basocelular in situ en la piel.
    13. Haber estado hospitalizado en los 3 meses anteriores a la selección por cualquier afección médica importante (según lo considere el investigador).
    14. Cardiopatía clínicamente significativa y/o anomalías clínicamente significativas en el ECG, incluyendo un QTcF > 450 ms en la selección, un bloqueo cardiaco de grado 2, taquiarritmia sintomática o arritmia inestable que, en opinión del investigador, deban excluir al sujeto de completar las pruebas de ejercicio (es decir, las pruebas de 12MWT y 30STS).
    15. Cualquier afección que pueda reducir la absorción del fármaco.
    16. Prueba de hospitalización por rabdomiólisis en el año anterior a la inscripción.
    17. Positivo en el antígeno de superficie de la hepatitis B (HBsAg), anticuerpos contra el antígeno nuclear de la hepatitis B (HBcAb) o hepatitis C o virus de la inmunodeficiencia humana (VIH) en la selección.
    18. Mujeres embarazadas o en periodo de lactancia.
    19. Antecedentes de sensibilidad a agonistas PPAR.
    20. Donación o intención de donar sangre o componentes sanguíneos durante el estudio o en el plazo de un mes tras la finalización del estudio.
    21. Antecedentes de dependencia farmacológica. El uso de opiáceos/cannabis por motivos médicos es aceptable con pruebas de prescripción o a criterio del investigador.
    22. Antecedentes de dependencia alcohólica.
    23. Deterioro significativo debido a la afectación del sistema nervioso central o periférico que interferiría en las pruebas de ejercicio.
    24. Debilidad significativa no causada por la enfermedad muscular primaria subyacente, como después de accidente cerebrovascular o debilidad neurógena.
    25. Con un trasplante de órganos.
    26. No aptos o concontraindicaciones para la cirugía de cataratas.
    27. Antecedentes de osteoporosis demostrados por fracturas no traumáticas (de esfuerzo) o una puntuación T previa de -2,5 o peor que no haya sido abordada adecuadamente.
    28. Incapacidad para comprender o no estar dispuesto a seguir los requisitos del estudio, incluidas las restricciones sobre los tratamientos, la asistencia al centro del estudio, la cumplimentación de cuestionarios y la participación en las pruebas analíticas, como se indica en el protocolo.
    29. Cualquier otra afección médica o psiquiátrica grave aguda o crónica o anomalía analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que pueda interferir con la interpretación de los resultados del estudio y, a juicio del investigador, y en consulta con el supervisor médico, haría que el sujeto fuera inadecuado para entrar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in distance walked during the 12 minute walk test
    Cambio desde la visita basal en la distancia caminada durante la prueba de caminata de 12 minutos
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 24 weeks
    a las 24 semanas
    E.5.2Secondary end point(s)
    Change from Baseline in the Modified Fatigue Impact Scale (MFIS) Physical sub-scale score.
    Patient Global Impression of Change (PGIC) score (muscle symptoms).
    Cambio desde el estado inicial en la puntuación de la subescala física de la Escala Modificada del Impacto de la Fatiga (MFIS)
    Escala de Impresión Global de Cambio del Paciente (PGIC) (síntomas musculares).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Baseline in the MFIS Physical sub-scale score:evaluation timepoint = 24 weeks
    PGIC score (muscle symptoms): evaluation timepoint = End of Treatment
    Cambio con respecto al estado inicial en la puntuación de la subescala física del MFIS: momento de evaluación = 24 semanas
    Puntuación PGIC (síntomas musculares): momento de evaluación = fin del tratamiento
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Canada
    New Zealand
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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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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