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    Summary
    EudraCT Number:2022-001671-14
    Sponsor's Protocol Code Number:221AD305
    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:2022-08-03
    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 number2022-001671-14
    A.3Full title of the trial
    A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer's Disease
    Estudio en fase IIIb/IV, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para verificar el beneficio clínico de aducanumab (BIIB037) en participantes con enfermedad de Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Verify the Clinical Benefit of Aducanumab in Participants with Early Alzheimer's Disease
    Estudio para verificar el beneficio clínico de aducanumab en participantes con enfermedad de Alzheimer temprana
    A.3.2Name or abbreviated title of the trial where available
    ENVISION
    ENVISION
    A.4.1Sponsor's protocol code number221AD305
    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 SponsorBiogen Idec Research Limited
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointBiogen España
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913107110
    B.5.5Fax number+34913107181
    B.5.6E-mailclinicaltrials@biogen.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 nameAducanumab
    D.3.2Product code BIIB037
    D.3.4Pharmaceutical form Concentrate for 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 INNAducanumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBIIB037
    D.3.9.4EV Substance CodeSUB180599
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant monoclonal antibody
    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
    Alzheimer's Disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Enfermedad de Alzheimer
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the CDR-SB score as compared with placebo in participants with early Alzheimer's disease.
    Verificar el beneficio clínico de dosis mensuales de aducanumab en la ralentización del deterioro cognitivo y funcional, según lo determinado por los cambios en la puntuación CDR-SB en comparación con placebo en participantes con enfermedad de Alzheimer temprana.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by the iADRS.
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by ADCS-ADL-MCI.
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by ADASCog13.
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by the MMSE.
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by NPI- 10.
    Objetivos secundarios clave:
    Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante la escala iADRS.
    Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el cuestionario ADCS-ADL-MCI.
    Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante la escala ADAS-Cog13.
    Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el examen MMSE.
    Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el inventario NPI-10.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Approximately 400 participants are expected to enroll in each of the following 3 biomarker sub-studies:
    1. Measurement of amyloid plaque burden in certain areas of the brain as measured by amyloid PET
    2. Measurement of neurofibrillary tangle burden in certain areas of the brain as measured by tau PET
    3. Measurement of disease- or treatment-related CSF biomarkers
    Se espera que se inscriban aproximadamente 400 participantes en cada uno de los 3 subestudios de biomarcadores siguientes:
    1. Medición de la carga de placas de amiloide en ciertas áreas del cerebro medida mediante TEP de amiloide
    2. Medición de la carga de ovillos neurofibrilares en ciertas áreas del cerebro medida mediante TEP de tau
    3. Medición de biomarcadores del LCR relacionados con la enfermedad o con el tratamiento
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - The participant must have confirmed amyloid beta pathology by CSF (historical CSF test results not allowed) or amyloid PET
    - The participant must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
    - The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
    - The participant must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to NIA-AA criteria [Albert 2011; McKhann 2011]:
    a. Have an MMSE score between 22 and 30 inclusive
    b. Have a CDR memory score >0.5
    c. Have a CDR-GS of 0.5 or 1.0
    d. Have a RBANS score of 85 or lower indicative of objective cognitive impairment (based upon the DMI score).
    - The participant must be in good health, apart from a clinical diagnosis of early Alzheimer's disease, as determined by the Investigator based on medical history and screening assessments
    - The participant must consent to ApoE genotyping
    - Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)
    Criterios de inclusión principales:
    - El participante debe tener patología β-amiloide confirmada mediante LCR (no se permiten los resultados de las pruebas históricas de LCR) o TEP de amiloide
    - El participante debe tener antecedentes de deterioro de la memoria subjetiva con inicio gradual y progresión lenta durante los 6 meses anteriores a la selección, confirmados por el acompañante del estudio
    - El participante debe tener a 1 informante o cuidador que, en opinión del investigador, tenga un contacto frecuente y suficiente con el participante (al menos 10 horas/semana de forma presencial o por teléfono) como para poder proporcionar información precisa sobre las capacidades cognitivas y funcionales del participante a lo largo del tiempo
    - El participante deberá cumplir todos los criterios clínicos siguientes para el DCL debido a enfermedad de Alzheimer o enfermedad de Alzheimer leve de acuerdo con los criterios del Instituto Nacional sobre el Envejecimiento y la Asociación de Alzheimer (NIA-AA) [Albert 2011; McKhann 2011]:
    a. tener una puntuación del examen MMSE entre 22 y 30, ambas inclusive;
    b. tener una puntuación de memoria CDR >0,5;
    c. tener una CDR-GS de 0,5 o 1,0;
    d. tener una puntuación RBANS de 85 o inferior indicativa de deterioro cognitivo objetivo (según la puntuación DMI).
    - El participante debe gozar de buena salud, además de un diagnóstico clínico de enfermedad de Alzheimer en fase inicial, según lo determine el investigador, de acuerdo con su historial médico y las evaluaciones de selección
    - El participante debe dar su consentimiento para la genotipificación de ApoE
    - Debe dar su consentimiento para la determinación de la genotipificación de la apolipoproteína E (ApoE). (Nota: No es necesario que los participantes sean portadores de ApoE ε4)
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment
    - Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening
    - Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
    - History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product
    - Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available
    - Current use or previous use of medications with a purported disease modifying effect in Alzheimer's disease, outside of investigational studies
    - Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures
    - Use of any investigational drug
    - Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)
    - A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening
    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
    Criterios de exclusión principales:
    - Cualquier afección médica o neurológica/neurodegenerativa no controlada (distinta de la enfermedad de Alzheimer) que, en opinión del investigador, pueda ser una causa que contribuya al deterioro cognitivo del participante
    - Enfermedad psiquiátrica clínicamente significativa y/o inestable en los 6 meses previos a la selección
    - Accidente isquémico transitorio, accidente cerebrovascular o pérdida de conciencia sin explicación en el plazo de 1 año antes de la selección
    - Antecedentes de reacciones alérgicas o anafilácticas graves o bien de hipersensibilidad a alguno de los excipientes del fármaco
    - Participación en cualquier estudio con supuesto efecto modificador de la enfermedad para la enfermedad de Alzheimer en los 12 meses previos a la selección, a menos que esté disponible la documentación de haber recibido placebo
    - Uso actual o uso previo de medicamentos con supuesto efecto modificador de la enfermedad en la enfermedad de Alzheimer, fuera de los estudios de investigación
    - El uso de cualquier medicamento que, a juicio del investigador, pueda contribuir al deterioro cognitivo, exponer al participante a un mayor riesgo de sufrir AA o deteriorar la capacidad del participante para realizar pruebas cognitivas o completar los procedimientos de estudio
    - Uso de cualquier fármaco en investigación
    - Exposición previa a aducanumab, ya sea comercialmente o mediante la participación en un estudio previo con aducanumab (los participantes son aptos si no recibieron aducanumab activo)
    - Resultado negativo en una TEP con ligandos de detección de amiloides en los 12 meses previos a la selección
    NOTA: También aplican otros criterios de Inclusión/Exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in CDR-SB score
    Cambio con respecto al inicio en la puntuación CDR-SB
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 78
    Semana 78
    E.5.2Secondary end point(s)
    1. Change from baseline in iADRS score
    2. Change from baseline in ADCS-ADL-MCI score
    3. Change from baseline in ADAS-Cog13 score
    4. Change from baseline in MMSE score
    5. Change from baseline in NPI-10 score
    6. Change from baseline in PET Signal
    7. Change from baseline in Tau PET Signal
    8. Change from baseline in CDR-SB Score
    9. Change from baseline in GST Composite Z-Score
    1. Cambio con respecto al inicio en la puntuación de la escala iADRS
    2. Cambio con respecto al inicio en la puntuación del cuestionario ADCS-ADL-MCI
    3. Cambio con respecto al inicio en la puntuación de la escala ADAS-Cog13
    4. Cambio con respecto al inicio en la puntuación del examen MMSE
    5. Cambio con respecto al inicio en la puntuación del inventario NPI-10
    6. Cambio con respecto al inicio en la señal de TEP
    7. Cambio con respecto al inicio en la señal de TEP de tau
    8. Cambio con respecto al inicio en la puntuación CDR-SB
    9. Cambio con respecto al inicio en la puntuación Z compuesta de GST
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 78, Week 106
    2. Week 78, Week 106
    3. Week 78, Week 106
    4. Week 78, Week 106
    5. Week 78, Week 106
    6. Week 78, Week 104
    7. Week 78, Week 104
    8. Week 106
    9. Week 78, Week 106
    1. Semana 78, semana 106
    2. Semana 78, semana 106
    3. Semana 78, semana 106
    4. Semana 78, semana 106
    5. Semana 78, semana 106
    6. Semana 78, semana 104
    7. Semana 78, semana 104
    8. Semana 106
    9. Semana 78, semana 106
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Verify the Clinical Benefit of the IMP
    Verificar el beneficio clínico del PEI
    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) Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Brazil
    Canada
    China
    Mexico
    United States
    Switzerland
    United Kingdom
    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
    UVUP (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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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.1.1.1In 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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1317
    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
    There maybe some patients who are incapable of giving consent personally.
    Puede que algunos pacientes sean incapaces de dar su consentimiento personalmente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 323
    F.4.2.2In the whole clinical trial 1512
    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)
    No further provisions are made for access to the study treatment. If aducanumab is proven to be beneficial, all regulatory requirements regarding poststudy access will be met.
    No hay más disposiciones para acceder al tratamiento del estudio. Si se demuestra que aducanumab es beneficioso, se cumplirán todos los requisitos normativos sobre el acceso posterior al estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DrugDev
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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