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    Summary
    EudraCT Number:2018-000844-25
    Sponsor's Protocol Code Number:R668-EE-1774
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-05-17
    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 number2018-000844-25
    A.3Full title of the trial
    A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)
    Estudio de 3 partes, aleatorizado, de fase III, para investigar la eficacia y la seguridad de dupilumab en pacientes adultos y adolescentes con esofagitis eosinofílica (EEo)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)
    Un estudio para determinar la eficacia y seguridad de dupilumab en pacientes adultos y adolescentes con esofagitis eosinofílica (EEo)
    A.4.1Sponsor's protocol code numberR668-EE-1774
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03633617
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedupilumab
    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 INNdupilumab
    D.3.9.2Current sponsor codeREGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedupilumab
    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 INNdupilumab
    D.3.9.2Current sponsor codeREGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    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 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 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
    Eosinophilic Esophagitis (EoE)
    Esofagitis eosinofílica (EEo)
    E.1.1.1Medical condition in easily understood language
    A chronic allergic/immune condition characterized by inflammation of the esophagus
    Enfermedad crónica alérgica/inmune caracterizada por la inflamación del esófago
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10064212
    E.1.2Term Eosinophilic oesophagitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study by study part are:
    Part A:
    To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures, and to inform/confirm the final sample size determination for Part B.
    Part B:
    To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.
    Part C:
    To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.
    Los objetivos principales para cada parte del estudio son:
    Parte A
    Determinar el efecto del tratamiento con dupilumab en comparación con placebo en pacientes adultos y adolescentes con EEo tras 24 semanas de tratamiento, evaluado mediante medidas histológicas y clínicas, y notificar/confirmar la determinación del tamaño muestral final para la Parte B.
    Parte B
    Demostrar la eficacia del tratamiento con dupilumab en comparación con placebo en pacientes adultos y adolescentes con EEo tras 24 semanas de tratamiento, evaluado mediante medidas histológicas y clínicas.
    Parte C
    Evaluar la seguridad y la eficacia del tratamiento con dupilumab en pacientes adultos y adolescentes con EEo tras un máximo de 52 semanas de tratamiento, según la evaluación de las medidas histológicas y clínicas.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    -To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
    -To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
    Los objetivos secundarios del ensayo son:
    •Evaluar la seguridad, tolerabilidad e inmunogenicidad del tratamiento con dupilumab durante un máximo de 52 semanas en pacientes adultos y adolescentes con EEo
    •Explorar la relación entre la concentración de dupilumab y las respuestas en pacientes adultos y adolescentes con EEo, utilizando análisis descriptivos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A documented diagnosis of EoE by endoscopic biopsy prior to screening
    2. Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
    3. History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
    1. Un diagnóstico documentado de EEo mediante biopsia endoscópica antes de la selección
    2. Las biopsias endoscópicas iniciales con una demostración en la lectura central de infiltración eosinofílica intraepitelial
    3. Antecedente (notificado por el paciente) de una media de 2 episodios de disfagia (con ingesta de sólidos) a la semana en las 4 semanas previas a la selección
    E.4Principal exclusion criteria
    Key Exclusion Criteria (Parts A & B):
    1. Body weight ≤40 kg
    2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
    3. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
    4. Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
    5. Active Helicobacter pylori infection
    6. History of achalasia, Crohn’s disease, ulcerative colitis, celiac disease, and prior esophageal surgery
    7. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
    8. History of bleeding disorders or esophageal varices
    9. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

    Key Exclusion Criteria (Part C):
    1. Participants who, during the double-blind treatment period (Part A or Part B), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant.
    2. Participants who became pregnant during the double-blind treatment period
    3. Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
    4. Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment
    Criterios de exclusión clave (Partes A y B):
    1. Peso corporal ≤40 kg
    2. Participación previa en un ensayo clínico de dupilumab, o tratamiento pasado o actual con dupilumab
    3. Inicio o cambio de un régimen dietario con eliminación de alimentos o reintroducción de un grupo alimentario eliminado previamente en las 6 semanas previas a la selección.
    4. Otras causas de eosinofilia de esófago o las siguientes afecciones: síndrome hipereosinofílico y granulomatosis eosinofílica con poliangitis (síndrome de Churg-Strauss)
    5. Infección activa por Helicobacter pylori
    6. Antecedentes de acalasia, enfermedad de Crohn, colitis ulcerosa, enfermedad celíaca y cirugía de esófago previa
    7. Cualquier estenosis esofágica que no se pueda superar mediante endoscopia superior diagnóstica, estándar, de 9 a 10 mm o cualquier estenosis esofágica que requiera dilatación en la selección
    8. Antecedentes de trastornos hemorrágicos o varices esofágicas
    9. Mujeres embarazadas o en periodo de lactancia, o mujeres que pretendan quedarse embarazadas o amamantar durante el estudio.
    Criterios de exclusión clave (parte C):
    1. Participantes que, durante el periodo de tratamiento doble ciego (parte A o parte B), desarrollaron un acontecimiento adverso grave (AAG) y/o un acontecimiento adverso (AA) que se considera relacionado con el fármaco del estudio, lo que en opinión del investigador podría indicar que la continuación del tratamiento con el fármaco del estudio podría representar un riesgo no justificado para el participante.
    2. Participantes que hayan quedado embarazadas durante el periodo de tratamiento doble ciego.
    3. Participantes que hayan interrumpido prematuramente el fármaco del estudio debido a un AA (los pacientes que hayan interrumpido prematuramente el fármaco del estudio debido a la falta de eficacia son aptos para incorporarse a la parte C).
    4. Pacientes que no se sometieron a endoscopia con biopsia antes de recibir el tratamiento de rescate.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints for both Parts A and B of the study are:
    - Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6
    eos/hpf at week 24
    - Absolute change in DSQ score from baseline to week 24
    Los criterios de valoración coprincipales para la Parte A y para la Parte B son:
    •Proporción de pacientes que logran un recuento máximo de eosinófilos intraepiteliales en el esófago de ≤6 eos/hpf en la semana 24
    •Cambio absoluto en la puntuación del DSQ desde el inicio hasta la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24. Note: All the above co-primary and secondary endpoints assessed at week 24 will be assessed at week 52 as secondary endpoints
    En la semana 24. Nota: Todos los criterios de valoración coprincipales y secundarios en la semana 24 se evaluarán en la semana 52 como criterios de valoración secundarios
    E.5.2Secondary end point(s)
    The key secondary endpoints of the study are:
    -Absolute change in EoE endoscopic reference score (EREFS) from baseline to week 24
    -Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf) from
    baseline to week 24
    -Absolute change in EoE Histology Scoring System (EoEHSS) from baseline to week 24

    The other secondary endpoints are:
    -Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤15 eos/hpf at week 24
    -Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤1 eos/hpf at week 24
    -Percent change in DSQ from baseline to week 24
    -Absolute change from baseline to week 24 in health-related QOL as measured by EoE Impact Questionnaire (EoE-IQ)
    -Absolute change from baseline to week 24 in severity and/or frequency of EoE symptoms other than dysphagia
    Los criterios de valoración secundarios clave para la Parte A y para la Parte B del estudio son:
    - Cambio absoluto en la puntuación de referencia endoscópica de esofagitis eosinofílica (Eosinophilic Esophagitis-Endoscopic Reference Score, EoE-EREFS) desde el inicio hasta la semana 24
    - Porcentaje de cambio en el recuento máximo de eosinófilos intraepiteliales en el esófago (eos/hpf) desde el inicio hasta la semana 24
    - Cambio absoluto en el sistema de puntuación en la histología de EEo (Absolute change in EoE Histology Scoring System, EoEHSS) desde el inicio hasta la semana 24
    Otros criterios de valoración secundarios incluyen los siguientes:
    - Proporción de pacientes que logran un recuento máximo de eosinófilos intraepiteliales en el esófago de ≤15 eos/hpf en la semana 24
    - Proporción de pacientes que logran un recuento máximo de eosinófilos intraepiteliales en el esófago de ≤1 eos/hpf en la semana 24
    - Porcentaje de cambio en el DSQ desde el inicio hasta la semana 24
    - Cambio absoluto desde el inicio hasta la semana 24 en la calidad de vida (CdV) relacionada con la salud medida por el cuestionario sobre el impacto de EEo (EoE Impact Questionnaire, EoE-IQ)
    - Cambio absoluto desde el inicio hasta la semana 24 en la intensidad y/o la frecuencia de los síntomas de EEo distintos de la disfagia
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 24. Note: All the above co-primary and secondary endpoints assessed at week 24 will be assessed at week 52 as secondary endpoints
    En la semana 24. Nota: Todos los criterios de valoración coprincipales y secundarios en la semana 24 se evaluarán en la semana 52 como criterios de valoración secundarios
    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 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
    Periodo de 24 semanas de tratamiento doble ciego seguido por una fase abierta de 28 semanas
    24-week double-blind treatment period followed by 28-week open-label treatment period
    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 trial3
    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 EEA39
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Portugal
    Spain
    Sweden
    Switzerland
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 42
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 42
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 368
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 425
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-15
    P. End of Trial
    P.End of Trial StatusRestarted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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