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    Summary
    EudraCT Number:2019-003752-36
    Sponsor's Protocol Code Number:M16-077
    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 number2019-003752-36
    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 Traumatic Cervical Spinal Cord Injury
    Estudio de prueba de concepto, aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y la eficacia del Elezanumab en la lesión aguda traumática de médula espinal cervical.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
    Seguridad y eficacia en la lesión aguda traumática de médula espinal cervical
    A.3.2Name or abbreviated title of the trial where available
    ELASCI
    ELASCI
    A.4.1Sponsor's protocol code numberM16-077
    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/6 mL
    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
    Spinal cord injury (SCI)
    Lesión de médula espinal (LME)
    E.1.1.1Medical condition in easily understood language
    Spinal cord injury (SCI)
    Lesión de médula espinal (LME)
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10041552
    E.1.2Term Spinal cord injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and efficacy of elezanumab in subjects with acute traumatic cervical SCI.
    Evaluar la seguridad y la eficacia de elezanumab en sujetos con LME cervical traumática aguda
    E.2.2Secondary objectives of the trial
    NA
    NA
    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, between 18 and 70 years of age, inclusive.
    - Acute traumatic cervical SCI, motor level of injury of C4, C5, C6, or C7 (cervical lesion as defined by first ISNCSCI) with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator's opinion, would significantly limit recovery.
    - Maximum screening UEMS of 32.
    - AIS grade A or B (2019 criteria) at Screening.
    - Able to initiate study drug administration within 24 hours of injury.
    - Los sujetos o su representante legalmente autorizado deben proporcionar voluntariamente el consentimiento informado antes de iniciar cualquier procedimiento específico del estudio, que esté aprobado por un comité de ética independiente (CEI)/junta de revisión institucional. En ausencia de la capacidad del sujeto para proporcionar el consentimiento informado, este debe ser proporcionado por una persona que tenga el derecho legal de actuar en nombre del sujeto de acuerdo con las leyes locales.
    - Hombres o mujeres adultos, entre 18 y 70 años, inclusive.
    - LME cervical traumática aguda, lesión motora a nivel de C4, C5, C6 o C7 (lesión cervical definida por la primera clasificación neurológica de estándar internacional para LME (ISNCSCI)) sin daño al cordón en las regiones torácica (T2 y más allá) y lumbar que, en opinión del investigador, limiten significativamente la recuperación.
    - Máxima puntuación motora de las extremidades superiores (UEMS, Upper Extremity Motor Score) de 32 en el screening.
    - Grados A o B en la escala de evaluación de la discapacidad de la asociación estadounidense de lesiones de la columna (AIS, ASIA Impairment Scale).
    - Sujetos capaces de iniciar la administración del fármaco del estudio en las 24 horas posteriores a la lesión.
    E.4Principal exclusion criteria
    - No absence of complete spinal cord transection, as demonstrated by MRI evidence of cord continuity at site of lesion confirmed by neuroradiologist.
    - Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT). CT required only for subjects suspected to have a brain injury at the discretion of the investigator.
    - Must have 1 or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
    - Known history prior to randomization of clinically significant medical or surgical conditions (other than current acute SCI) or any other reason, including any physical, psychological, or psychiatric condition that in the opinion of the Investigator would compromise the safety or interfere with the subject's participation in this study, or would make the subject an unsuitable candidate to receive study drug, or would put the subject at risk by participating in the study, including history of or abnormal screening lab or imaging results that, in the opinion of the investigator, are indicative of any irreparable cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major disease that would preclude administration of elezanumab.
    - Known receipt of any other investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical 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.
    - Ausencia completa de transección de la médula espinal, demostrada la continuidad de la médula en una resonancia magnética de la lesión y confirmada por el neuro-radiólogo.
    - Lesión en la cabeza significativa y concomitante con una anormalidad clínicamente significativa en una tomografía computarizada (TAC). El TAC se requiere solo para sujetos sospechosos de tener una lesión cerebral a discreción del investigador.
    - Debe tener 1 o más grupos musculares de las extremidades superiores inestables (por ejemplo, inmovilizados o restringidos por un yeso) durante el examen de ISNCSCI del screening.
    - Historial conocido antes de la aleatorización de afecciones médicas o quirúrgicas clínicamente significativas (que no sean las LME agudas actuales) o por cualquier otro motivo, incluida cualquier condición física, psicológica o psiquiátrica que, en opinión del investigador, comprometería la seguridad o interferiría con la participación del sujeto en este estudio, o convertiría al sujeto en un candidato inadecuado para recibir el fármaco del estudio, o lo pondría en riesgo al participar en el estudio, incluyendo antecedentes o resultados anormales en análisis de laboratorio o imágenes que, en opinión del investigador, son indicativo de cualquier enfermedad cardíaca, endocrina, hematológica, hepática, inmunológica, infecciosa, metabólica, urológica, pulmonar, gastrointestinal, dermatológica, psiquiátrica, renal, neurológica y/u otra enfermedad grave que impida la administración de elezanumab.
    - Que el sujeto haya recibido cualquier otro producto en investigación en los 30 días o 5 semividas del medicamento (lo que sea más largo) antes de la primera dosis del medicamento del estudio o que esté actualmente inscrito en otro estudio clínico.
    - Mujer que está embarazada, durante la lactancia o considerando quedarse embarazada durante el estudio o dentro de las 39 semanas (5 semividas) después de la última dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the Upper Extremity Motor Score (UEMS), a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2019 criteria) during the Treatment Period.
    El criterio de valoración principal es la UEMS, un punto de los criterios ISNCSCI, durante el período de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    UEMS scores between treatment and placebo.
    Puntuación UEMS entre el tratamiento y el placebo
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - Spinal Cord Independence Measures (SCIM III) self-care score,
    - UEMS change from Baseline
    Los criterios de valoración secundarios son:
    - Puntuación de autocuidado en las medidas de independencia de la médula espinal (SCIM III, Spinal Chord Independence Measures)
    - Cambios en la UEMS desde la visita basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    - SCIM-III is over the duration of the study
    - UEMS change from baseline at week 52
    - SCIM-III: durante el estudio
    - UEMS: cambio desde la visita basal hasta la semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study subjects will 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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 54
    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)
    At the subject's last study visit, the investigator will discuss the appropriate subsequent treatment options available (as applicable) with the subject which may include other non-AbbVie treatment.
    En la última visita del sujeto en el estudio, el investigador discutirá las opciones de tratamiento posteriores apropiadas disponibles (según corresponda) con el sujeto, que pueden incluir otro tratamiento que no sea de AbbVie.
    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 Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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