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    Summary
    EudraCT Number:2021-001200-15
    Sponsor's Protocol Code Number:ALXN1210-DM-310
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-16
    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 number2021-001200-15
    A.3Full title of the trial
    A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis.
    Estudio de fase II/III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de ravulizumab en participantes adultos con dermatomiositis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.
    Ravulizumab frente a placebo en participantes adultos con dermatomiositis
    A.3.2Name or abbreviated title of the trial where available
    Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.
    Ravulizumab frente a placebo en participantes adultos con dermatomiositis
    A.4.1Sponsor's protocol code numberALXN1210-DM-310
    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 SponsorAlexion 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 supportAlexion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number+34932723019
    B.5.6E-mailclinicaltrials.eu@alexion.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 Ultomiris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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 nameRavulizumab
    D.3.2Product code ALXN1210
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNRAVULIZUMAB
    D.3.9.1CAS number 1803171-55-2
    D.3.9.3Other descriptive nameALXN1210
    D.3.9.4EV Substance CodeSUB172162
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 Ultomiris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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 nameRavulizumab
    D.3.2Product code ALXN1210
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNRAVULIZUMAB
    D.3.9.1CAS number 1803171-55-2
    D.3.9.3Other descriptive nameALXN1210
    D.3.9.4EV Substance CodeSUB172162
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 injection
    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
    Dermatomyositis
    Dermatoniositis
    E.1.1.1Medical condition in easily understood language
    Dermatomyositis is a rare disease that causes muscle inflammation and skin problems (rash and swelling).
    La dermatomiositis es una enfermedad rara que causa inflamación de los músculos y problemas en la piel (erupción e hinchazón)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012503
    E.1.2Term Dermatomyositis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PART A
    To determine the effect of ravulizumab compared with placebo in the treatment of DM based on improvement in Total Improvement Score (TIS) as per 2016 ACR/EULAR Myositis Response Criteria for adult DM (also known as IMACS).

    PART B
    To determine the effect of ravulizumab compared with placebo in the treatment of DM based on improvement in Total Improvement Score (TIS) as per 2016 ACR/EULAR Myositis Response Criteria for adult DM (also known as IMACS)
    PARTE A
    Determinar el efecto de ravulizumab en comparación con placebo en el tratamiento de la DM sobre la base de la Puntuación de mejoría total (TIS) según los Criterios de Respuesta de la Miositis del ACR/EULAR de 2016 para la DM en adultos (también conocidos como IMACS).

    PARTE B
    Determinar el efecto de ravulizumab en comparación con placebo en el tratamiento de la DM sobre la base de la Puntuación de mejoría total (TIS) según los Criterios de Respuesta de la Miositis del ACR/EULAR de 2016 para la DM en adultos (también conocidos como IMACS).
    E.2.2Secondary objectives of the trial
    PART A
    To assess the efficacy of ravulizumab compared with placebo in the treatment of DM based on improvement in efficacy endpoints.
    To characterize the PK/PD and immunogenicity of ravulizumab in adult participants with DM.
    To characterize the overall safety of ravulizumab in participants with DM.

    PART B
    To assess the efficacy of ravulizumab compared with placebo in the treatment of DM based on improvement in components of IMACS and other myositis activity measures
    To assess the efficacy of ravulizumab compared with placebo in the treatment of DM based on other efficacy endpoints
    To characterize the PK/PD and immunogenicity of ravulizumab in adult participants with DM
    To characterize the overall safety of ravulizumab in participants with DM
    PARTE A
    Evaluar la eficacia de ravulizumab en comparación con placebo en el tratamiento de la DM sobre la base de la mejora de los criterios de valoración de la eficacia.
    Describir la FC/FD y la inmunogenicidad de ravulizumab en participantes adultos con DM.
    Describir la seguridad global de ravulizumab en participantes con DM.

    PARTE B
    Evaluar la eficacia de ravulizumab en comparación con placebo en el tratamiento de la DM basada en la mejora de los componentes del IMACS y otras medidas de la actividad de la miositis
    Evaluar la eficacia de ravulizumab en comparación con placebo en el tratamiento de la DM sobre la base de otros criterios de valoración de la eficacia
    Describir la FC/FD y la inmunogenicidad de ravulizumab en participantes adultos con DM
    Describir la seguridad global de ravulizumab en participantes con DM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    1. 18 years of age or older at the time of signing the informed consent.
    2.Body weight ≥ 30 kg at the time of Screening.
    3. Male or female.
    4. Diagnosis: Meet American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for definite or probable DM (Lundberg, 2017).
    5. Participants who have an inadequate response (ie, continued impairment by medical doctor report) or are intolerant to 2 or more DM treatments, including systemic corticosteroids or ISTs (eg, azathioprine, methotrexate, rituximab, IVIg), either in combination or as monotherapy.
    6. Vaccinated against Neisseria meningitidis within 3 years prior to, or at the time of, initiating ravulizumab. Participants who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics until 2 weeks after the vaccination.
    7. Female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol.
    Únicamente podrán ser incluidos en el estudio los participantes que cumplan todos los criterios siguientes:
    1. Edad mínima de 18 años en el momento de firmar el documento de consentimiento informado.
    2. Peso corporal ≥30 kg en el momento de la selección.
    3. Varón o mujer.
    4. Diagnóstico: se cumplen los criterios de clasificación del American College of Rheumatology/Liga Europea contra el Reumatismo (ACR/EULAR) de 2017 para la DM definitiva o probable (Lundberg, 2017).
    5. Participantes con respuesta insuficiente (es decir, deterioro continuo según el informe del médico) o intolerancia a 2 o más tratamientos para la DM, incluidos glucocorticoesteroides sistémicos o tratamiento inmunodepresor (TID; p. ej., azatioprina, metotrexato, rituximab, IgIV), en combinación o en monoterapia.
    6. Vacunación contra Neisseria meningitidis en el momento de iniciar el tratamiento con ravulizumab o en los 3 años previos. Los participantes que inicien el tratamiento de intervención del estudio menos de 2 semanas después de recibir una vacuna antimeningocócica deberán recibir antibióticos profilácticos adecuados durante al menos 2 semanas después de la vacunación.
    7. Las mujeres con capacidad reproductiva y los varones participantes deberán seguir las directrices sobre métodos anticonceptivos especificadas que se describen en el protocolo.
    E.4Principal exclusion criteria
    1. Cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 3 months before screening).
    2. Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors).
    3. Participants with other forms of myositis
    4. Participants with significant muscle damage (eg, severe muscle atrophy, end stage muscle disease) as per investigator opinion.
    5. History of Neisseria meningitidis infection.
    6. Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer).
    7. Active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration.
    8. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration on Day 1.
    9. History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab.
    10. Pregnant, breastfeeding, or intending to conceive during the course of the study.
    11. Inability or unwillingness to adhere to the protocol requirements
    1. Miositis asociada a cáncer, definida como el diagnóstico de miositis en los 3 años siguientes al diagnóstico de cáncer (excepto cáncer basocelular o espinocelular o carcinoma in situ del cuello uterino que se haya extirpado y curado y al menos 3 meses antes de la selección).
    2. Indicios de enfermedad maligna activa o neoplasias malignas diagnosticadas en los 5 años previos (incluidas neoplasias malignas hematológicas y tumores sólidos).
    3. Participantes con otras formas de miositis
    4. Participantes con lesión muscular importante (p. ej., atrofia muscular grave, enfermedad muscular terminal) según la opinión del investigador.
    5. Antecedentes de infección por Neisseria meningitidis
    6. Infección por el virus de la inmunodeficiencia humana (VIH) (demostrada por el título de anticuerpos contra el VIH de tipo 1 o 2).
    7. Infección bacteriana, vírica o fúngica sistémica activa en los 14 días previos a la administración de ravulizumab.
    8. Presencia de fiebre ≥38 °C en los 7 días previos a la administración de la intervención del estudio el día 1.
    9. Antecedentes de hipersensibilidad a proteínas murinas o a uno de los excipientes de ravulizumab.
    10. Embarazo, lactancia materna o intención de concebir durante el estudio.
    11. Incapacidad o falta de disposición para cumplir los requisitos del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    PART A
    Proportion of participants with a ≥ 20-point improvement response on TIS (TIS20) at Week 26 of the Randomized-Controlled Period

    PART B
    Proportion of participants with a ≥ 20-point improvement response on TIS (TIS20) at Week 50 of the Randomized-Controlled Period
    PARTE A
    Proporción de participantes con una respuesta de mejora ≥20 puntos en TIS (TIS20) en la semana 26 del período aleatorizado y controlado

    PARTE B
    Proporción de participantes con una respuesta de mejoría ≥20 puntos en TIS (TIS20) en la semana 50 del período aleatorizado y controlado
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: Week 26
    Part B: Week 50
    PARTE A: Semana 26
    PARTE B: Semana 50
    E.5.2Secondary end point(s)
    PART A
    • Mean TIS at Week 26
    • Mean change from baseline in CDASI Activity Score at Week 26
    • Change from baseline of IMACS core set measures at Week 26
    • Time to first CDASI Activity Score improvement
    • Change in Investigator Global Assessment (IGA) at Week 26

    PART B
    • Mean TIS at Week 50
    • Mean change from baseline in MMT-8 at Week 50
    • Mean change from baseline in extra-muscular disease activity based on MDAAT at Week 50
    • Mean change from baseline in CDASI Activity Score at Week 50
    • Mean change from baseline in individual 6 CSM used for TIS calculation
    • Time to first CDASI Activity Score improvement
    PARTE A
    • TIS media en la semana 26
    • Variación media de la puntuación de actividad CDASI entre el momento basal y la semana 26
    • Variación de cada una de las mediciones básicas del IMACS entre el momento basal y la semana 26
    • Tiempo hasta la primera mejora de la puntuación de la actividad CDASI
    • Variación de la Evaluación Global del Investigador (IGA) en la semana 26

    ParteB
    • TIS media en la semana 50
    • Variación media del MMT-8 entre el momento basal y la semana 50
    • Variación media de la actividad de la enfermedad extramuscular basada en la MDAAT entre el momento basal y la semana 50
    • Variación media de la puntuación de actividad CDASI entre el momento basal y la semana 50
    • Variación media en los 6 CSM individuales utilizados para el cálculo de TIS desde el momento basal.
    • Tiempo hasta la primera mejora de la puntuación de la actividad CDASI
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 26
    semana 26
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Italy
    Spain
    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
    A participant is considered to have completed the study if the participant has completed all periods (Randomized-Controlled Period and OLE Period) of the study including the last scheduled procedure shown in the SoA (Section 1.3) of the protcol.
    The end of the study is defined as the date the last participant completes the last visit shown in the SoA.
    Se considera que un participante ha completado el estudio si ha completado todos los períodos [Período aleatorizado y controlado y Período de extensión en régimen abierto (OLE)] del estudio, incluido el último procedimiento programado que se muestra en el calendario de actividades (Sección 1.3) del protocolo.
    El final del estudio se define como la fecha en que el último participante completa la última visita que se muestra en el calendario de actividades.
    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 months10
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days6
    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: 180
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 180
    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)
    This study will be conducted in 2 parts: Part A (Phase 2) and Part B (Phase 3). An OLE period was chosen to ensure that all participants in this study will have the opportunity to receive active treatment after the completion of the Randomized-Controlled Period of the study. This OLE period also allows for further evaluation of longer-term safety and efficacy of the study intervention (74 weeks).
    Este estudio se llevará a cabo en 2 partes: Parte A (Fase 2) y Parte B (Fase 3). Se eligió un período de extensión abierto (OLE) para garantizar que todos los participantes de este estudio tengan la oportunidad de recibir tratamiento activo después de la finalización del período aleatorizado controlado del estudio. Este período OLE también permite una evaluación adicional de la seguridad y eficacia a más largo plazo de la intervención del estudio (74 semanas).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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