Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004431-23
    Sponsor's Protocol Code Number:WN41874
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2019-004431-23
    A.3Full title of the trial
    AN OPEN-LABEL, MULTI-CENTER, ROLL-OVER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE
    STUDIO ROLL-OVER, IN APERTO E MULTICENTRICO, VOLTO A VALUTARE LA SICUREZZA E LA TOLLERABILITÀ DELLA SOMMINISTRAZIONE A LUNGO TERMINE DI GANTENERUMAB IN PAZIENTI AFFETTI DA 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 and Tolerability of Long-Term Administration of Gantenerumab in Participants with Alzheimer’s disease.
    Uno studio per valutare la sicurezza e la tollerabilità della somministrazione a lungo termine di Gantenerumab nei pazienti con malattia di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    To evaluate Safety and Tollerability of Gantenerumab in patients with Alzheimer's disease
    Valutare l'efficacia e la tollerabilità di Gantenerumab in pazienti affetti da malattia di Alzheimer
    A.4.1Sponsor's protocol code numberWN41874
    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.Hoffman-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 code4070
    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 CodeSUB190296
    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) 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 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 typeRecombinant human 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 (AD)
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    AD is a chronic neurodegenerative disease that destroys memory and other important mental functions.
    L'AD è un disturbo progressivo che causa problemi con la memoria ed altre importanti funzioni mentali.
    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 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 long-term safety and tolerability of continued treatment with subcutaneous (SC) gantenerumab at target dose in participants with AD who received gantenerumab in open-label extension (OLEs) of Studies WN25203 or WN28745
    Valutare la sicurezza e la tollerabilità a lungo termine della prosecuzione del trattamento con gantenerumab s.c. alla dose target in pazienti affetti da AD che hanno ricevuto gantenerumab nella fase OLE dello studio WN25203 o dello studio WN28745
    E.2.2Secondary objectives of the trial
    Not applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - All participants who completed the OLEs of Studies WN25203 or WN28745 (i.e., latest version of protocol in their countries, and did not discontinue study drug early) are eligible to participate in this study
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
    - Sono considerati idonei all’ingresso nello studio in oggetto tutti i pazienti che hanno partecipato alla fase OLE dello studio WN25203 o dello studio WN28745 e l’hanno completata (ovvero ultima versione del protocollo nei rispettivi paesi e senza interruzione anticipata del trattamento sperimentale).
    - Per le donne in età fertile: consenso a praticare l’astinenza dai rapporti eterosessuali o a fare uso di metodi contraccettivi con tasso di insuccesso < 1% all’anno durante il periodo di trattamento e per almeno 16 settimane dopo la somministrazione dell’ultima dose del trattamento sperimentale
    E.4Principal exclusion criteria
    - Prematurely discontinued from the OLEs of Studies WN25203 or WN28745 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
    - If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant’s best interest, by determination of the investigator or Sponsor
    - Any investigational treatment other than gantenerumab during or since completion of the OLEs of Studies WN25203 or WN28745
    - Pregnancy
    - Evidence of disseminated leptomeningeal hemosiderosis
    - Evidence of intracerebral macrohemorrhage
    - interruzione anticipata, per qualsiasi motivo, della partecipazione alla fase OLE dello studio WN25203 o dello studio WN28745 oppure del trattamento sperimentale
    - presenza di una condizione medica che, a giudizio dello sperimentatore o dello sponsor, potrebbe compromettere la sicurezza del/della paziente se questi/a continuasse ad assumere il trattamento sperimentale
    - eventualità in cui sia improbabile che il/la paziente tragga beneficio dalla terapia con gantenerumab, in base alla progressione della malattia o ad altri fattori, oppure eventualità in cui, a giudizio dello sperimentatore o dello sponsor, la partecipazione allo studio non risulti essere nel miglior interesse del/della paziente
    - assunzione di un trattamento sperimentale diverso da gantenerumab durante la fase OLE dello studio WN25203 o dello studio WN28745 o dopo il suo completamento
    - gravidanza
    - evidenza di emosiderosi leptomeningea disseminata (ossia più di tre emosiderosi leptomeningee focali)
    - evidenza di macroemorragia intracerebrale.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence, nature, severity, and timing of adverse events and serious adverse events
    2. Changes from baseline in vital signs, blood tests
    3. Changes from baseline in electrocardiogram
    4. Changes from baseline in the Columbia-Suicide Severity Rating Scale (C SSRS)
    5. Incidence, nature, severity, and timing of magnetic resonance imaging (MRI) safety findings: amyloid-related imaging abnormality–edema/effusion (ARIA E) and amyloid-related imaging abnormality–hemosiderin depositions (ARIA H)
    6. Incidence, nature, severity, and timing of injection-site reaction (ISRs)
    7. Number and proportion of anti-drug antibody (ADA)-positive and ADA-negative participants during both the treatment and follow-up periods
    8. Incidence of treatment discontinuations for adverse events
    9. Incidence of adverse events of special interest

    1 incidenza, natura, gravità e tempistica degli AE e dei SAE
    2 variazioni, rispetto al basale dello studio in oggetto, nelle misurazioni dei segni vitali, nei valori delle analisi del sangue
    3 variazioni, rispetto al basale dello studio in oggetto nei parametri degli ECG
    4 variazioni, rispetto al basale dello studio in oggetto nel punteggio della scala C-SSRS
    5 incidenza, natura, gravità e tempistica dei riscontri RM in termini di sicurezza: ARIA-E e ARIA-H
    6 incidenza, natura, gravità e tempistica delle reazioni al sito d’iniezione (Injection-Site Reaction, ISR)
    7 numero e percentuale di pazienti ADA-positivi e ADA-negativi durante la fase di trattamento e di follow-up
    8 incidenza delle interruzioni del trattamento a causa di AE
    9 incidenza degli AE di particolare interesse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 4 weeks after the last dose of the study drug
    2. Baseline (Day 1) to 4 weeks after the last dose of the study drug
    3. At baseline and unscheduled visit (UV)
    4-5. Baseline, Week 24, Week 52, Week 76, Week 104, follow-up (FU)/ early termination (ET) visit, UV
    6. Up to 4 weeks after the last dose of the study drug
    7. Day 1, Week 52, Week 104, FU/ET visit
    8-9. Up to 4 weeks after the last dose of the study drug
    1. Fino a 4 settimane dopo l'ultima dose del farmaco in studio
    2. Basale (giorno 1) a 4 settimane dopo l'ultima dose del farmaco in studio
    3. Alla visita basale e alla visita non programmata (UV)
    4-5. Basale, settimana 24, settimana 52, settimana 76, settimana 104, visita di follow-up (FU) / visita di termine anticipata (ET), UV
    6. Fino a 4 settimane dopo l'ultima dose del farmaco in studio
    7. Giorno 1, settimana 52, settimana 104, visita FU / ET
    8-9. Fino a 4 settimane dopo l'ultima dose del farmaco in studio
    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 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Canada
    Chile
    Denmark
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 study is defined as the date when the last participant last visit (LPLV) occurs or the date on which the last data point required for safety follow-up is received from the participant in the study.
    La fine dello studio è definita come la data in cui si verifica l'ultima visita dell'ultimo partecipante (LPLV) o la data in cui l'ultimo punto di dati richiesto per il follow-up di sicurezza viene ricevuto dal partecipante allo studio.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 159
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 175
    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 evaluate the of continuing to prescribe gantenerumab to participants on the basis of emerging data from other studies.
    Lo sponsor valuterà la possibilità di continuare a prescrivere gantenerumab ai partecipanti sulla base dei dati emergenti provenienti da altri studi
    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 Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA