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    Summary
    EudraCT Number:2020-000766-42
    Sponsor's Protocol Code Number:WN42171
    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:2020-10-21
    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 number2020-000766-42
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB
    ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE
    STUDIO IN APERTO, MULTICENTRICO, ROLL-OVER PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L'EFFICACIA DELLA SOMMINISTRAZIONE A LUNGO TERMINE DI GANTENERUMAB NEI PARTECIPANTI CON MALATTIA DI ALZHEIMER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants with Alzheimer's Disease
    Uno studio per valutare la sicurezza, la tollerabilità e l'efficacia della
    Somministrazione a lungo termine di Gantenerumab nei partecipanti con malattia di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberWN42171
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0000000
    B.5.5Fax number0000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGantenerumab
    D.3.2Product code [RO4909832]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGANTENERUMAB
    D.3.9.2Current sponsor codeRO4909832
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832
    D.3.9.4EV Substance CodeSUB177613
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) No
    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 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 placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease is a progressive disease beginning with mild memory loss possibly leading to loss of the ability to carry on a conversation and respond to the environment
    La malattia di Alzheimer è una malattia progressiva che inizia con una lieve perdita di memoria che può portare alla perdita della capacità di continuare una conversazione e di rispondere all'ambiente
    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 HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal Alzheimer's disease
    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 evaluate the safety and tolerability of long-term gantenerumab administered by SC injection
    Valutare la sicurezza e la tollerabilità del gantenerumab a lungo termine somministrato per iniezione SC
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of long-term gantenerumab administered by SC injection
    • To characterize the pharmacokinetic (PK) profile of gantenerumab administered by SC injection
    • To evaluate the immune response to gantenerumab administered by SC injection
    • To evaluate the long-term effects of gantenerumab on fluid and image based biomarkers administered by SC injection
    - valutare l'efficacia del gantenerumab a lungo termine somministrato per iniezione SC
    - Caratterizzare il profilo farmacocinetico (PK) di gantenerumab somministrato per iniezione SC
    - Valutare la risposta immunitaria al gantenerumab somministrato per iniezione SC
    - valutare gli effetti a lungo termine di gantenerumab su biomarcatori fluidi e basati su immagini somministrati mediante iniezione SC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: LONGITUDINAL AMYLOID PET IMAGING SUBSTUDY ASSOCIATED WITH AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE (v1 del 07.03.2020)
    The main objective of the WN42171 longitudinal amyloid PET substudy is to assess changes in brain amyloid load (as measured by florbetaben or flutemetamol) over time using the change from baseline of the double-blind part of the parent study (WN29922 or WN39658) to OLE Week 104

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: SOTTOSTUDIO LONGITUDINALE DI IMAGING CON PET AMOLOIDE ASSOCIATO ALLO STUDIO IN APERTO, MULTICENTRICO, ROLL-OVER PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L’EFFICACIA DELLA SOMMINISTRAZIONE A LUNGO TERMINE DI GANTENERUMAB NEI PARTECIPANTI CON MALATTIA DI ALZHEIMER (v1 del 07.03.2020)
    L’obiettivo principale del sottostudio longitudinale PET amiloide WN42171 è valutare le variazioni del carico di amiloide nel cervello (misurato mediante florbetaben o flutemetamolo) nel corso del tempo utilizzando la variazione dal basale della parte in doppio cieco dello studio originario (WN29922 o WN39658) alla Settimana di estensione in aperto (Open-Label Extension, OLE) 104
    E.3Principal inclusion criteria
    • Completed Study WN29922 or WN39658, either its double-blind part (participants have reached the 510 mg Q2W dose schedule by the time of completion) or OLE part (participants have received at least 3 doses of 510 mg Q4W), and did not discontinue study drug early
    • Ability to comply with the study protocol
    • Willingness and ability to complete all aspects of the study (including MRI and lumbar puncture [if applicable]).
    • The participant should be capable of completing assessments either alone or with the help of the caregiver
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 16 weeks after the
    final dose of gantenerumab
    • Completamento dello studio WN29922 o dello studio WN39658, nella parte in doppio cieco (al momento del completamento i partecipanti avranno raggiunto la dose di 510 mg Q2W) o nella parte OLE (i partecipanti avranno ricevuto almeno 3 dosi di 510 mg Q4W), e nessuna interruzione anticipata dello studio
    • Capacità di rispettare il protocollo dello studio
    • Disponibilità e capacità di completare tutti gli aspetti dello studio (comprese RM e puntura lombare [se del caso]).
    • Il partecipante deve essere in grado di completare le valutazioni in modo autonomo o con l’aiuto del caregiver
    • Per le donne potenzialmente fertili: consenso a praticare l’astinenza sessuale (astenersi dai rapporti eterosessuali) oppure a utilizzare misure contraccettive durante il periodo di trattamento e per almeno 16 settimane dopo l’ultima dose di gantenerumab
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
    • Prematurely discontinued from Study WN29922 or WN39658, either its double-blind or OLE part, as applicable, or from study drug, for any reason
    • Any medical condition that the investigator or Sponsor determines may jeopardize the participant’s safety if he or she continues to receive study treatment
    • Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part, as applicable
    • Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
    • Evidence of intracerebral macrohemorrhage
    • Use of prohibited medication
    • Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
    • Gravidanza o allattamento, o gravidanza pianificata durante lo studio o nelle 16 settimane successive all’ultima dose del farmaco dello studio
    • Interruzione anticipata dello studio WN29922 o dello studio WN39658, nella parte in doppio cieco o nella parte OLE, se del caso, o del farmaco dello studio, per qualsiasi motivo
    • Qualsiasi patologia che lo sperimentatore o lo Sponsor ritengano possa pregiudicare la sicurezza del partecipante qualora continuasse a ricevere il trattamento dello studio
    • Assunzione di qualsiasi trattamento sperimentale diverso da gantenerumab durante gli studi WN29922 o WN39658 (nella parte in doppio cieco o nella parte OLE) o dopo il loro completamento
    • Evidenza di emosiderosi leptomeningea disseminata (ossia, più di tre focolai di emosiderosi leptomeningea)
    • Evidenza di macroemorragia intracerebrale
    • Uso di medicinali proibiti
    • Evidenza di ARIA-E nell’ultimo referto di RM nello studio WN29922 o nello studio WN39658, nella parte in doppio cieco o nella parte OLE
    E.5 End points
    E.5.1Primary end point(s)
    1. Nature, frequency, severity, and timing of adverse events and serious adverse events
    2. Physical examinations (including neurologic systems), vital signs, blood tests, and Columbia-Suicide Severity Rating Scale (C-SSRS)
    3. Nature, frequency, severity, and timing of ARIA-E and ARIA-H
    4. Nature, frequency, severity, and timing of ISRs
    1 Natura, frequenza, gravità, tempistiche ed esiti degli eventi avversi e degli eventi avversi gravi
    2 Esami obiettivi (compreso il sistema neurologico), parametri vitali, esami del sangue e C SSRS
    3 Natura, frequenza, gravità e tempistiche delle anomalie ARIA-E e ARIA-H
    4 Natura, frequenza, gravità, tempistiche ed esiti delle reazioni alla sede di iniezione
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-4. Up to Week 116
    1-4 Fino alla settimana 116
    E.5.2Secondary end point(s)
    Efficacy
    1. Change over time in Clinical Dementia Rating (CDR)
    2. Change over time in Mini-Mental State Examination (MMSE)
    3. Change over time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADASCog13) and Subscale 11 (ADAS-Cog11)
    4. Change over time in Verbal Fluency Task
    5. Change over time in Coding
    6 Change over time in Functional Activities Questionnaire (FAQ)
    7. Change over time in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

    PK
    8. Plasma concentration of gantenerumab administered SC at specified timepoints

    Immunogenicity
    9. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
    Efficacia
    1. Cambiamenti nel tempo nella valutazione della demenza clinica (CDR)
    2. Cambiamenti nel tempo nell'esame di stato mini-mentale (MMSE)
    3. Variazioni nel tempo in Cognizione della scala di valutazione della malattia di Alzheimer, Sottoscala 13 (ADASCog13) e Sottoscala 11 (ADAS-Cog11)
    4. Cambio nel tempo dell'abilitità di fluidità verbale
    5. Cambio nel tempo del Coding
    6. Modifica nel tempo nel questionario sulle attività funzionali (FAQ)
    7. Cambiamenti nel tempo nel gruppo di studio sulle attività di studio cooperativo sulla malattia di Alzheimer (ADCS-ADL)
    PK
    8. Concentrazione plasmatica di gantenerumab somministrato SC a specifici timepoints
    Immunogenecità
    9. Prevalenza di anticorpi anti-farmaco (ADA) al basale e incidenza di ADA durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7. Baseline to Week 104
    8-9. Up to Week 116
    1-7. Dal basale alla settimana 104
    8-9. Fino alla settimana 116
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker, Health Status Utility
    Immunogenicità, Biomarcatori, Utilità dello Stato di Salute
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 EEA108
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    China
    Croatia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Singapore
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    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
    The end of this study is defined as the date when the last participant, last visit, occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last participant, whichever occurs later. The end of the study is expected to occur by the end of 2024.
    La conclusione di questo studio coinciderà con la data di effettuazione dell’ultima visita da parte dell’ultimo partecipante oppure con la data in cui saranno ricevuti gli ultimi dati richiesti per l’analisi statistica o il follow-up di sicurezza dell’ultimo partecipante, a seconda di quale dei due eventi si verificherà dopo. Si prevede che lo studio terminerà entro la fine del 2024.
    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 months5
    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 months5
    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: 293
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1170
    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
    Signed Informed Consent Form by the participant with AD and/or the legal authorized representative as per local requirements
    Modulo di consenso informato firmato dal partecipante con AD e / o rappresentante legale autorizzato secondo i requisiti locali
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 468
    F.4.2.2In the whole clinical trial 1463
    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)
    The Sponsor will offer continued access to Roche IMP gantenerumab free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in protocol section 4.3.5.
    The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Lo sponsor offrirà l'accesso continuo a Roche IMP gantenerumab gratuitamente ai partecipanti idonei in conformità con la Politica globale di Roche sull'accesso continuo al medicinale in fase di sperimentazione, come indicato nella sezione 4.3.5 del protocollo.
    La politica globale di Roche sull'accesso continuo al medicinale in fase di sperimentazione è disponibile sul seguente sito Web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2020-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-11-14
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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