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    Summary
    EudraCT Number:2017-002901-37
    Sponsor's Protocol Code Number:251AD201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-24
    Trial results View 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 number2017-002901-37
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects with Mild Cognitive Impairment due to Alzheimer’s Disease or with Mild Alzheimer’s Disease
    Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare la sicurezza, la tollerabilità e l’efficacia di BIIB092 in soggetti con deterioramento cognitivo lieve causato da malattia di Alzheimer o con malattia di Alzheimer di lieve entità
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
    Studio di fase 2 di BIIB092 in partecipanti con malattia di Alzheimer in fase iniziale
    A.4.1Sponsor's protocol code number251AD201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03352557
    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.3.2Product code BIIB092
    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 INNNot yet available
    D.3.9.2Current sponsor codeBIIB092
    D.3.9.3Other descriptive nameBMS986168
    D.3.9.4EV Substance CodeSUB186860
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized 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
    Mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD
    Deterioramento cognitivo lieve (Mild cognitive impairment,MCI) causato da malattia di Alzheimer (Alzheimer’s disease, AD) o malattia di Alzheimer di lieve entità
    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
    To evaluate the safety and tolerability of BIIB092 in subjects with MCI due to AD or with mild AD
    Valutare la sicurezza e la tollerabilità di BIIB092 in soggetti con MCI causato da AD o con AD di lieve entità.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in subjects with MCI due to AD or with mild AD.

    To evaluate the immunogenicity of BIIB092 after multiple doses in subjects with MCI due to AD or with mild AD.
    - Valutare l’efficacia di dosi multiple di BIIB092 nel rallentamento di deficit cognitivi e funzionali in soggetti con MCI causati da AD o con AD di lieve entità.
    - Valutare l’immunogenicità di BIIB092 a seguito di dosi multiple in soggetti con MCI causato da AD o con AD di lieve entità.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    • Must have a gradual and progressive change in memory function over more than 6 months.
    • Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD and must have
    o Objective evidence of cognitive impairment at Screening
    o Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
    o Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
    o CDR Memory Box score of ≥0.5
    • Must consent to apolipoprotein E (ApoE) genotyping
    • Must have 1 informant/study partner
    • Must have amyloid beta positivity confirmed at Screening
    Criteri di inclusione:
    • Deve avere un cambiamento graduale e progressivo nella funzione mnemonica su più di 6 mesi.
    • Deve soddisfare tutti i criteri clinici per il deterioramento cognitivo lieve (MCI) dovuto alla malattia di Alzheimer (AD) o AD lieve e deve avere
    o evidenza oggettiva del deterioramento cognitivo allo Screening
    o punteggio globale della scala di valutazione della demenza clinica (Clinical Dementia Rating Scale, CDR) di 0,5 per MCI dovuta ad AD o 0,5 o 1 per AD lieve
    o punteggio Mini-Mental State Examination (MMSE) da 22 a 30 (incluso)
    o punteggio CDR Memory Box di ≥0,5
    • Deve consentire la genotipizzazione dell'apolipoproteina E (ApoE)
    • Deve disporre di 1 informatore / partner di studio
    • Deve avere una positività alla beta amiloide confermata allo Screening
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    • Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant’s cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
    • Clinically significant, unstable psychiatric illness
    • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
    • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
    • History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
    • Indication of impaired renal or liver function
    • Alcohol or substance abuse in past 1 year
    • Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
    • Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1.
    • Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant’s ability to perform cognitive testing or complete study procedures.
    • Contraindications to study procedures

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
    Principali criteri di esclusione:
    • Qualsiasi condizione medica o neurologica / neurodegenerativa (diversa dall'AD) che, secondo il parere dello sperimentatore, potrebbe essere una causa che contribuisce al deterioramento cognitivo del partecipante o potrebbe portare alla sospensione, alla mancanza di conformità, a interferenze con le valutazioni dello studio o a problemi di sicurezza
    • Malattia psichiatrica clinicamente significativa e instabile
    • Ha avuto un ictus o attacco ischemico transitorio (Transient Ischemic Attack, TIA) o perdita di coscienza inspiegabile nell'ultimo 1 anno
    • Emorragia cerebrale rilevante, disturbo emorragico e anomalie cerebrovascolari
    • Storia di angina instabile, infarto miocardico, insufficienza cardiaca cronica o anomalie di conduzione clinicamente significative entro 1 anno prima della visita di screening 1
    • Indicazione di funzionalità renale o epatica compromessa
    • Abuso di alcol o sostanze negli ultimi 1 anni
    • Malattia sistemica clinicamente significativa o infezione grave entro 30 giorni prima o durante il periodo di screening
    • Uso di farmaci consentiti per condizioni croniche a dosi che non sono state stabili per almeno 4 settimane prima della Visita di screening 1, o uso di farmaci per AD a dosi che non sono state stabili per almeno 8 settimane prima della Visita di Screening 1.
    • Uso di eventuali farmaci che, secondo il parere dello sperimentatore, possono contribuire al deterioramento cognitivo, mettere i partecipanti a rischio più elevato per eventi avversi (adverse events, AEs), o compromettere la capacità del partecipante di eseguire test cognitivi o completare le procedure di studio.
    • Controindicazioni alle procedure di studio

    NOTA: possono essere applicati altri criteri di inclusione / esclusione definiti dal protocollo
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
    • Percentage of Participants With Abnormal Laboratory Safety Assessments
    • Percentage of Participants With Changes From Baseline Over Time in Laboratory Safety Assessments
    • Percentage of Participants With Abnormal Vital Signs
    • Percentage of Participants With Changes From Baseline Over Time in Vital Signs
    • Percentage of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Assessments
    • Percentage of Participants With Changes From Baseline in Over Time in 12-Lead Electrocardiogram (ECG) Assessments
    • Percentage of Participants With Changes in Physical Examinations Assessments
    • Percentuale di partecipanti con eventi avversi (Adverse Events, AEs) e eventi avversi gravi (Serious Adverse Events, SAEs). AEs: qualsiasi segno, sintomo o diagnosi / malattia che sia sfavorevole o non intenzionale, che sia nuovo o, se preesistente, peggiori nei partecipanti a cui venga somministrato un prodotto farmaceutico e che non ha necessariamente una relazione causale con questo trattamento. SAE: un evento che provoca la morte; un evento che, dal punto di vista dello Sperimentatore, pone il partecipante a rischio immediato di morte (un evento potenzialmente letale); un esito che si traduce in un'anomalia congenita / difetto alla nascita diagnosticato al figlio/alla figlia di un partecipante; un evento che richiede o prolunga il ricovero ospedaliero; un evento che si traduce in invalidità / incapacità persistente o significativa. Qualsiasi altro evento importante dal punto di vista medico che, secondo il parere dello sperimentatore, possa mettere a repentaglio il partecipante o richiedere un intervento per prevenire uno degli altri esiti elencati nella definizione sopra riportata.
    • Percentuale di partecipanti con valutazioni di sicurezza di laboratorio anomali
    • Percentuale di partecipanti con variazioni nel tempo rispetto al basale nelle valutazioni di sicurezza di laboratorio
    • Percentuale di partecipanti con segni vitali anomali
    • Percentuale di partecipanti con variazioni nel tempo rispetto al basale nei segni vitali
    • Percentuale di partecipanti con valutazione anomale negli elettrocardiogrammi a 12 derivazioni (ECG)
    • Percentuale di partecipanti con variazioni rispetto al basale nel tempo in valutazioni di elettrocardiogramma a 12 derivazioni (ECG)
    • percentuale di partecipanti con modifiche nelle valutazioni degli esami fisici
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to week 90
    Fino alla settimana 90
    E.5.2Secondary end point(s)
    • Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
    • Percentage of Participants With Anti-BIIB092 Antibodies in Serum Over Time up to Week 90
    • Cambiamento dal basale nel tempo alla settimana 78 sulla Scala di valutazione della demenza clinica - Sum of Boxes (Clinical Dementia Rating Scale - Sum of Boxes, CDR-SB)
    • Percentuale di partecipanti con anticorpi anti-BIIB092 nel siero nel tempo fino alla settimana 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    • For CDR-SB the timeframe is up to week 78
    • For participants with Anti-BIIB092 Abs, the time frame is up to week 90
    • Per CDR-SB il periodo di tempo è fino alla settimana 78
    • Per i partecipanti con Anti-BIIB092 Abs, l'intervallo di tempo è fino a settimana 90
    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 No
    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
    Evaluation of biomarkers for AD
    Valutazione dei biomarcatori per l'AD
    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 trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    France
    Germany
    Italy
    Japan
    Poland
    Spain
    Sweden
    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
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 292
    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
    At the start of the study, participants must be capable of giving consent personally, however, as study progress participants might need legal representative to provide consent
    All'inizio dello studio, i partecipanti devono essere in grado di dare il consenso personalmente, tuttavia, durante il progredire dello studio, i partecipanti potrebbero aver bisogno di un legale rappresentante per fornire il consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 528
    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, unless the subject elects to
    enter an extension study following the Week 78 Visit (to be initiated at the Sponsor’s discretion).
    Non sono previste ulteriori disposizioni per l'accesso al trattamento di studio, a meno che il soggetto non scelga di entrare in uno studio di estensione dopo la visita della settimana 78 (da avviare a discrezione dello Sponsor).
    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 IQVIA
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation IQVIA Ireland
    G.4.3.4Network Country Ireland
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Endpoint Bracket
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation MESM
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation TrialNetworks Firecrest
    G.4.3.4Network Country Ireland
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation PPD Pharmacovigilance
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation MedAvante Cogstate
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Quintiles BBK
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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