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    Summary
    EudraCT Number:2019-003753-29
    Sponsor's Protocol Code Number:M19-148
    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:2020-05-15
    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 number2019-003753-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
    Estudio de prueba de concepto, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de Elezanumab en ictus isquémico agudo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
    Estudio de eficacia y seguridad de Elezanumab en ictus isquémico agudo
    A.3.2Name or abbreviated title of the trial where available
    EAISE
    EAISE
    A.4.1Sponsor's protocol code numberM19-148
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-mailabbvie_reec@abbvie.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 nameElezanumab
    D.3.2Product code ABT-555
    D.3.4Pharmaceutical form 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 INNELEZANUMAB
    D.3.9.1CAS number 1791416-49-3
    D.3.9.2Current sponsor codeABT-555
    D.3.9.4EV Substance CodeSUB188644
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600 mg/ 6mL
    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 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
    Acute Ischemic Stroke
    Ictus isquémico agudo
    E.1.1.1Medical condition in easily understood language
    STROKE
    ICTUS
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system 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 assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of elezanumab in subjects with acute ischemic stroke.
    Evaluar la eficacia, seguridad, tolerabilidad y farmacocinética (FC) de Elezanumab en pacientes con ictus isquémico agudo.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subjects or their legally authorized representative must voluntarily provide informed consent prior to the initiation of any study-specific procedure in a form approved by an independent ethics committee (IEC)/institutional review board (IRB). In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
    -Adult male or female, 30 to 80 years of age, inclusive.
    -Clinical diagnosis of acute ischemic stroke within 23 hours of last known normal, supported by acute brain computed tomography (CT) or MRI consistent with the clinical diagnosis.
    -Evidence of infarct within anterior circulation based on either clinical assessment and/or acute imaging.
    -NIHSS total score of 7 to 21, inclusive. NIHSS eligibility must be confirmed within 1 hour before randomization. For subjects treated with IV tPA, NIHSS must be confirmed ≥ 1 hour after completion of IV tPA treatment.
    -Subjects or their legally authorized representative confirms that prior to index stroke, no significant impairment in subject's ability to perform activities of daily living (e.g., dressing, eating, walking, bathing, toileting) without assistance. Subjects with a history of stroke more than 6 months prior to enrollment are allowed, if there was no residual neurologic deficit, and subject was able to function independently prior to index stroke (e.g., pre-morbid mRS of 0 or 1).
    -Los pacientes o su representante legal autorizado deben proporcionar su consentimiento informado de forma voluntaria antes del inicio de cualquier procedimiento específico del estudio a través de un documento aprobado por un comité de ética independiente (CEI). Si el paciente no es capaz de proporcionar su consentimiento informado, éste debe ser dado por una persona que tenga el derecho legal de actuar por ese paciente de acuerdo con la legislación vigente.
    -Varones o mujeres adultos de entre 30 y 80 años, ambos inclusive.
    -Diagnóstico clínico de ictus isquémico agudo en las 23 horas siguientes a la última vez orientado/consciente contrastado por una TC o RM cerebral aguda compatible con el diagnóstico clínico y disponible en la historia del sujeto.
    -Evidencia de infarto en la circulación anterior basada en la evaluación clínica y/o imágenes precisas.
    -Puntuación total de la NIHSS de 7 a 21, ambos inclusive. La elegibilidad según la NIHSS debe confirmarse en la hora previa a la aleatorización. En los sujetos tratados con tPA IV, la NIHSS deberá confirmarse ≥ 1 hora después del tratamiento.
    -Los pacientes o su representante legal autorizado confirman que antes de la apoplejía no ha ocurrido ninguna disfución relevante en la capacidad del paciente de realizar cualquier actividad del día a día (por ejemplo, vestirse, comer, caminar, ducharse, ir al baño) sin ayuda. Aquellos pacientes con un historial de apoplejía de más de seis meses antes de la inclusión pueden entrar en el estudio si no hay déficit neurológico residual y el paciente era capaz de valerse por sí mismo antes de la apoplejía (por ejemplo, mRS pre-mórbidos de 0 o 1).
    E.4Principal exclusion criteria
    -Evidence of severe stroke on imaging based on available acute imaging studies performed under the standard of care.
    -The index acute ischemic stroke is intended to be treated with endovascular therapy (intra-arterial tPA and/or mechanical thrombectomy), i.e., subjects who will be treated with endovascular therapy are not eligible.
    -Evidence of seizure at the onset of index stroke based on assessments conducted per standard of care.
    -Evidence of acute myocardial infarction based on assessments based on assessments per standard of care (e.g., elevated troponin levels, abnormal ECG).
    -Symptoms are considered likely to resolve within the subsequent few hours (e.g., transient ischemic attack [TIA]).
    -Known medical history of repeated episodes of complex migraine (e.g., weakness, vision, difficulty speaking). Subjects with history of complex migraine, but with imaging conclusively demonstrating an acute ischemic stroke are still allowed.
    -Known history prior to randomization of clinically significant medical conditions (other than current acute ischemic stroke) or any other reason, including any physical, psychological, or psychiatric condition that in the investigator's opinion would compromise the safety or interfere with the subject's participation in this study.
    -Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for within 39 weeks (5 half-lives) after the last dose of study drug.
    -Evidencia de accidente cerebrovascular grave contrastado con imágenes basadas en estudios de imagen aguda disponibles realizados según la práctica habitual.
    -El índice de ictus isquémico agudo con intención de tratar con terapia endovascular (tPA intrarterial y/o trombectomía mecánica), ejemplo, los sujetos que sean tratados con terapia endovascular no son elegibles.
    -Evidencia de convulsiones al inicio del índice de ICTUS basado en evaluaciones realizadas por práctica habitual
    -Evidencia de infarto agudo de miocardio basada en la evaluación por práctica habitual. (por ejemplo, niveles elevados de troponina, ECG anormal).
    -Se considera que probablemente los síntomas se resuelvan en las siguientes horas (por ejemplo, ataque isquémico transitorio [AIT]).
    -Antecedentes médicos conocidos de repetidos episodios de migraña compleja (por ejemplo, debilidad, dificultades en la visión y para hablar). Los pacientes con historia de migraña compleja, pero con imágenes concluyentes que demuestran un accidente cerebrovascular isquémico agudo todavía pueden ser incluidos.
    -Antecedentes conocidos antes de la randomización, de afecciones médicas clínicamente significativas (distintas del actual accidente cerebrovascular isquémico agudo) o cualquier otra razón, incluyendo cualquier condición psicológica o psiquiátrica que, en opinión del investigador, comprometería la seguridad o interferiría con la participación del paciente en este estudio.
    -Mujeres embarazadas, en período de lactancia o que estén considerando quedarse embarazadas durante el estudio o durante las 39 semanas siguientes (5 semividas) tras la última dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the National Institutes of Health Stroke Scale (NIHSS) total score during the Treatment Period.
    El objetivo primario es la puntuación total en la Escala de ICTUS del National Institutes of Health (NIHSS) durante el período de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NIHSS total score between elezanumab and placebo.
    Comparar la puntuación total de la NIHSS entre Elezanumab y placebo.
    E.5.2Secondary end point(s)
    The secondary endpoint is the responder status based on the modified Rankin Scale (mRS) at Week 52.
    El objetivo secundario es el estado de respuesta basado en la escala de Rankin modificada (mRS) en la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A responder is defined as having an mRS score of 0, 1, or 2 at the specified time point.
    Un paciente con respuesta se define como aquel que tiene una puntuación mRS de 0, 1 o 2 en el momento especificado.
    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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Canada
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study subjects may not be able to provide written consent due to their injury, however consent will be obtained as allowed per applicable National and/or Regional law and as approved by the governing EC/IRB.
    Los sujetos del estudio pueden no ser capaces de proporcionar su consentimiento por escrito debido a su lesión, sin embargo, el consentimiento se obtendrá conforme a la legislación nacional o regional vigente y la aprobación del CEIm correspondiente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 80
    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)
    Ischemic stroke is an emergent event requiring acute intervention, followed by a period of recovery. After the acute phase, some eligible patients may undergo rehabilitation, and many patients will be prescribed medications for prevention of subsequent stroke. These treatments will be permitted during the conduct of the study. After completing trial, patients may continue to be treated according to SoC. AbbVie will not provide any additional care beyond the study-specified procedures.
    Ictus isquémico agudo, acontec. emergente que requiere interv. crucial seguridad seguido de un periodo de recuperación. Después de fase aguda, pacientes elegibles pueden someterse a rehabilitación y a muchos se les prescribirá medicación para prevenir apoplejía post. Durante estudio, estos tratamientos están permitidos. Al completar estudio, pacientes pueden continuar tratamiento según práctica habitual. AbbVie no proporcionará ningún tratamiento adicional a los procedim. especif. del estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-10
    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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