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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);
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    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.
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    EudraCT Number:2019-004431-23
    Sponsor's Protocol Code Number:WN41874
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-28
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-004431-23
    A.3Full title of the trial
    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.
    Estudio para evaluar la seguridad y tolerancia de la administración de Gantenerumab a largo plazo en participantes con enfermedad de Anzheimer
    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.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.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.5.4Telephone number+34913257300
    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.3.9.2Current sponsor codeRO4909832
    D.3.9.4EV Substance CodeSUB190296
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. 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)
    Enfermedad de Alzheimer (EA)
    E.1.1.1Medical condition in easily understood language
    AD is a chronic neurodegenerative disease that destroys memory and other important mental functions.
    EA es una enfermedad neurodegenerativa que destruye la memoria y otras funciones mentales importantes
    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
    Evaluar la seguridad y la tolerancia a largo plazo del tratamiento continuado con gantenerumab SC utilizando la dosis establecida, en participantes con EA que han recibido gantenerumab en las partes OLE de los estudios WN25203 o WN28745
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    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
    - Todos los participantes que hayan completado la parte de extensión abierta de los estudios WN25203 o WN28745 (es decir, de acuerdo con la última versión del protocolo aplicable a sus respectivos países y que no hayan terminado prematuramente el tratamiento con el fármaco del estudio) son elegibles para participar en este estudio.
    - Las mujeres potencialmente fértiles deben comprometerse a practicar la abstinencia sexual o a usar métodos anticonceptivos con una tasa de fallos anual de <1%, durante el período de tratamiento y como mínimo hasta 16 semanas después de la administración de la última dosis del fármaco del estudio.
    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
    - Retirada prematura de la parte de extensión abierta de los estudios WN25203 o WN28745 o del fármaco del estudio por cualquier motivo
    - Cualquier afección que, de acuerdo con el criterio del investigador o del promotor, pueda comprometer la seguridad del participante si continúa recibiendo el tratamiento del estudio
    - El investigador o el promotor consideran que hay pocas probabilidades de que el participante se beneficie del tratamiento con gantenerumab, basándose en la progresión de la enfermedad u otros factores, o si por otros motivos la participación en el estudio no es lo más apropiado para el paciente
    - Administración de cualquier tratamiento en investigación distinto de gantenerumab durante la parte de extensión abierta de los estudios WN25203 o WN28745 o desde su terminación
    - Embarazo
    - Evidencia de hemosiderosis leptomeníngea diseminada
    - Evidencia de macrohemorragia intracerebral
    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.Incidencia, tipo, gravedad y momento de aparición de los acontecimientos adversos
    2.Cambios producidos respecto a la situación basal en las constantes vitales, resultados de los análisis de sangre
    3.Cambios producidos respecto a la situación basal en electrocardiograma
    4.Cambios producidos respecto a la situación basal en Columbia-Suicide Severity Rating Scale (C-SSRS)
    5.Incidencia, tipo, gravedad y momento de aparición de los hallazgos de seguridad en la resonancia magnética (RM): anomalías en la imagen relacionadas con amiloide- edema/derrame (ARIA-E) y anomalías en la imagen relacionadas con amiloide-depósitos de hemosiderina (ARIA-H)
    6.Incidencia, tipo, gravedad y momento de aparición de las reacciones en el lugar de la inyección (RLI)
    7.Número y porcentaje de participantes con anticuerpos antifármaco (ADA) positivo y ADA negativo durante los períodos de tratamiento y seguimiento
    8.Incidencia de casos que requieren la suspensión del tratamiento debido a acontecimientos adversos
    9.Incidencia de acontecimientos adversos de especial interés
    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.Hasta 4 semanas después de la última dosis del fármaco del estudio.
    2.Desde la visita basal (día 1) hasta 4 semanas después de la última dosis del fármaco del estudio
    3.En la visita basal y no programada (UV)
    4-5.Basal, Semana 24, Semana 52, Semana 76, Semana 104, visita de seguimiento (FU) / terminación temprana (ET), UV
    6.Hasta 4 semanas después de la última dosis del fármaco del estudio.
    7.Día 1, Semana 52, Semana 104, visita de segumiento / visita de terminación temprana
    8-9.Hasta 4 semanas después de la última dosis del fármaco del estudio.
    E.5.2Secondary end point(s)
    Not Applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplica
    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. 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 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 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 concerned7
    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 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
    Korea, Republic of
    Russian Federation
    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 terminación del estudio se define como la fecha en la que tiene lugar la última visita del último participante (UVUP) o en la que se reciben los últimos datos del último participante en el estudio, requeridos para el seguimiento de la seguridad.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 state24
    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.
    El promotor evaluará la posibilidad de continuar prescribiendo gantenerumab a los participantes sobre la base de datos emergentes de otros estudios.
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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