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    Summary
    EudraCT Number:2019-004368-22
    Sponsor's Protocol Code Number:221AD304
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004368-22
    A.3Full title of the trial
    Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer’s disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
    Studio di fase 3b, in aperto, multicentrico, sulla sicurezza di BIIB037 (aducanumab) in soggetti affetti da malattia di Alzheimer che avevano precedentemente partecipato agli studi su aducanumab 221AD103, 221AD301, 221AD302 e 221AD205
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer’s Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
    Uno studio per valuare la sicurezza e la tollerabiltà di Aducanumab in partecipanti con malattia di Alzheimer che avevano precedentemente partecipato agli studi su aducanumab 221AD103, 221AD301, 221AD302 e 221AD205
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code number221AD304
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04241068
    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 pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    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.3.9.2Current sponsor codeBIIB037
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Malattia di 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
    The primary objective is to evaluate the long-term safety and tolerability of aducanumab after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).
    L’obiettivo primario dello studio è valutare la sicurezza e la tollerabilità a lungo termine di aducanumab dopo un periodo di wash-out imposto dalla sospensione degli studi precedenti nei partecipanti che avevano precedentemente ricevuto aducanumab (ossia, partecipanti precedentemente trattati ) o che avevano precedentemente ricevuto placebo (ovvero, partecipanti naive al trattamento).
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (Studies 221AD301, 221AD302, 221AD103 and 221AD205, referred to as “feeder studies”).
    - Has one care partner who, in the Investigator’s opinion, has adequate contact with the participant as to be able to provide accurate information about the participant’s cognitive and functional abilities.
    Other protocol defined Inclusion criteria may apply.
    - Il/La partecipante stava partecipando a uno studio clinico di aducanumab al momento della comunicazione di interruzione anticipata (Studi 221AD301, 221AD302, 221AD103 e 221AD205, denominati “studi precedenti”).
    - Ha un/a compagno/a che lo/a assiste che, a parere dello sperimentatore, è sufficientemente in contatto con il/la partecipante da poter fornire informazioni accurate sulle capacità cognitive e funzionali del/la partecipante.
    Possono essere applicati altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    - Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment.
    -Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
    -Clinically significant unstable psychiatric illness in past 6 months.
    -History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
    - A seizure event that occurred after the last visit the feeder study and before Screening for this study.
    - Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
    - History of or known seropositivity for HIV.
    - Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
    - Contraindications to having a brain magnetic resonance imaging (MRI).
    Other protocol defined Exclusion criteria may apply.
    - Qualsiasi condizione medica o neurologica (diversa dalla malattia di Alzheimer) che potrebbe essere una causa che contribuisce al deterioramento cognitivo del soggetto.
    - Ictus o qualsiasi perdita di coscienza inspiegata nell’anno precedente lo screening.
    - Malattia psichiatrica instabile clinicamente significativa negli ultimi 6 mesi.
    - Anamnesi di angina instabile, infarto del miocardio, insufficienza cardiaca cronica avanzata o anomalie di conduzione clinicamente significative nell’anno precedente lo screening.
    - Un evento di crisi convulsiva che si è verificato dopo ll'ultima visita dello studio precedente e prima dello screening per questo studio.
    - Evidenza di compromissione della funzionalità epatica, dimostrato da un profilo di funzionalità epatica anomalo allo screening.
    - Anamnesi o sieropositività nota per l’HIV.
    - Malattia sistemica clinicamente significativa o infezione grave nei 30 giorni precedenti o durante lo screening.
    - Controindicazioni alla risonanza magnetica (RM) del cervello.
    Possono essere applicati altri criteri di esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.

    2. Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    3. Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E)
    Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.

    4. Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)
    MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.

    5. Number of Participants With Antiaducanumab Antibodies (antidrug antibodies, ADAs) in Serum
    Presence of serum ADAs will be determined using a validated assay.
    1. Numero di partecipanti con eventi avversi (AE) ed eventi avversi seri (SAE)
    Un evento avverso (AE) è un evento clinico sfavorevole che si verifica in un partecipante o in un partecipante a una sperimentazione clinica che abbia ricevuto un prodotto farmaceutico che non deve essere necessariamente in relazione causale con tale trattamento.
    Un AE può quindi consistere in qualsiasi segno (compreso un valore di laboratorio anomalo), sintomo o quadro patologico sfavorevole e non voluto temporaneamente associato all’impiego di un prodotto medicinale (sperimentale), correlato o meno al prodotto medicinale (sperimentale) stesso. Un SAE è qualsiasi evento clinico sfavorevole che a qualsiasi dosaggio provoca il decesso o un evento potenzialmente letale, richiede il ricovero, provoca invalidità/incapacità significativa o anomalia congenita.
    2. Numero di partecipanti con AE che hanno portato all’interruzione del trattamento o al ritiro dallo studio
    Un evento avverso (AE) è un evento clinico sfavorevole che si verifica in un partecipante o in un partecipante a una sperimentazione clinica che abbia ricevuto un prodotto farmaceutico che non deve essere necessariamente in relazione causale con tale trattamento.
    Un AE può quindi consistere in qualsiasi segno (compreso un valore di laboratorio anomalo), sintomo o quadro patologico sfavorevole e non voluto temporaneamente associato all’impiego di un prodotto medicinale (sperimentale), correlato o meno al prodotto medicinale (sperimentale) stesso.
    3. Il numero di partecipanti con anomalie a livello di risonanza magnetica (RM) correlate all’amiloide - edema (ARIA-E) sarà utilizzato per valutare la gravità delle ARIA-E come lieve, moderata e grave.
    4. Il numero di partecipanti con anomalie a livello di risonanza magnetica (RM) correlate all’amiloide - emorragie (ARIA-H) sarà utilizzato per valutare la gravità delle microemorragie ARIA-H e della siderosi superficiale.
    5. Il numero di partecipanti con presenza di anticorpi anti-aducanumab nel siero sarà determinato utilizzando un saggio convalidato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2: Up to Week 118
    3,4,5: Up to Week 102
    1, 2: Fino alla Settimana 118
    3,4,5: Fino alla Settimana 102
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    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 Information not present in EudraCT
    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
    Japan
    Korea, Republic of
    Taiwan
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days5
    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: 1600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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.
    There maybe some patients who are incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 906
    F.4.2.2In the whole clinical trial 2400
    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.
    Non sono previste ulteriori disposizioni per l’accesso al trattamento dello studio. Qualora aducanumab dimostri di apportare benefici, tutti i requisiti normativi riguardanti l’accesso post-studio saranno soddisfatti.
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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