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    Summary
    EudraCT Number:2015-003034-27
    Sponsor's Protocol Code Number:BN29552
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-003034-27
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE- BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND
    SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODOMAL-TO-MILD ALZHEIMER’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL- TO-MILD ALZHEIMER’S DISEASE
    A.4.1Sponsor's protocol code numberBN29552
    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. Hoffman-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 code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161 688 1111
    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 namecrenezumab
    D.3.2Product code Ro 549-0245/F05
    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.3.8INN - Proposed INNcrenezumab
    D.3.9.1CAS number 1095207-05-8
    D.3.9.2Current sponsor codeRO5490245
    D.3.9.3Other descriptive nameCrenezumab, Anti Abeta, MABT5102A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 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 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
    Alzheimer’s Disease (AD)
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s Disease
    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
    Efficacy:evaluate crenezumab 60mg/kg compared with placebo when admin. by IVinfusion q4w over 100wks as measured by the CDR-SB(final outcome assessment at Wk 105,4 wks after final dose)Change from baseline on CDR-sum of boxes
    Safety:evaluate safety of crenezumab compared with placebo in patients with prodromal to mild AD on the basis of following endpoints
    •Nature,frequency,severity and timing of adverse events and serious adverse events
    •Physical and neurologic examinations,vital signs,blood tests,ECGs,Columbia Suicide Severity Rating Scale,Non-serious adverse events of special interest,specific.pneumonia
    •Adverse events,as assessed by magnetic resonance imaging:amyloid related imaging abnormalities edema/effusion and amyloid related imaging abnormalities hemosiderin deposition
    •Immunogenic potential of crenezumab through measurement of antibodies directed against crenezumab and other components of the drug product,assessment of their relationship with other outcome measures
    E.2.2Secondary objectives of the trial
    Efficacy: secondary efficacy objectives for this study are to evaluate the benefits of crenezumab versus placebo administered to patients by IV
    infusion Q4W over 100 weeks through assessment of the following endpoints
    Change from baseline to Week 105 on:
    •Cognition, as assessed by the ADAS-Cog (subscale) 13 (ADAS Cog 13) and 11 (ADAS-Cog-11)
    •severity of dementia, assessed using the CDR-Global Score (CDR GS) and MMSE
    •function, assessed using the ADCS-ADL instrumental subscale (ADCSiADL) and ADCS-ADL total score
    •neuropsychological symptoms, assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) total score
    •Effect of crenezumab on health−related quality of life (QoL), assessed using the Quality of Life−Alzheimer's Disease scale, caregiver burden, assessed using the Zarit Caregiver Interview for Alzheimer's Disease scale and on health outcomes in patient and caregiver as measured by EQ-5D
    • Measure of dependence derived from the ADCS-ADL score
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ECG SUBSTUDY ASSOCIATED WITH:
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

    CONCORDANCE SUBSTUDY ASSOCIATED WITH:
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

    PET LONGITUDINAL SUBSTUDY ASSOCIATED WITH:
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

    CSF LONGITUDINAL SUBSTUDY ASSOCIATED WITH:
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

    RESEARCH SUBSTUDY ASSOCIATED WITH:
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
    E.3Principal inclusion criteria
    • Must meet clinical criteria for MCI due to AD or mild AD (per NIAAA criteria) and must have:
    • A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0
    • Objective evidence of cognitive impairment at screening
    • An MMSE score ≥22
    • Must have evidence of AD pathology confirmed by positive amyloid assessment (by PET scan or CSF measurement)
    • Must consent to genotyping for apolipoprotein E (ApoE)
    • If using drugs to treat symptoms related to AD, doses must be stable for at least 3 months prior to screening
    • Must have a reliable study partner or caregiver
    E.4Principal exclusion criteria
    • Any medical or neurological condition (other than Alzheimer's Disease) that might result in cognitive impairment.
    • Have had a stroke resulting in clinical symptoms within 2 years or Transient Ischemic Attack (TIA) within 6 months
    • History of serious psychiatric illness or untreated major depressive disorder
    • History of unstable angina, myocardial infarction, advanced chronic heart failure within 2 years prior to screening
    • Have human immunodeficiency virus (HIV) infection
    • Relevant brain hemorrhage or cerebrovascular abnormalities
    • Any contraindications to brain magnetic resonance imaging (MRI) scans
    • Alcohol or substance abuse in past 2 years
    • Anti-coagulation medications within 3 months of screening – antiplatelet therapies including clopidogrel are permitted.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate crenezumab 60 mg/kg compared with placebo when administered by IV infusion q4w over 100 weeks as measured by the following primary endpoint (final outcome assessment at Week 105, 4 weeks after the final dose): Global outcomes, as assessed by the CDR SB
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline at week 105
    E.5.2Secondary end point(s)
    To evaluate the benefits of crenezumab versus placebo administered to patients by IV infusion q4w over 100 weeks through assessment of the
    following endpoints: Effect on cognition, as assessed by the ADAS-Cog (subscale) 13 (ADAS Cog 13) and 11 (ADAS-Cog-11); effect on dementia severity as assessed by CDR Global Score (CDR-GS) and MMSE; effect on function as assessed by the ADCS-ADL total score and the ADCSinstrumental ADL subscore; effect on a measure of dependence derived from the ADCS-ADL score; effect on neuropsychological symptoms assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline at week 105
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 Yes
    E.8.2.3.1Comparator description
    PET Ligand (florbetapir F18)
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA119
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Costa Rica
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Poland
    Portugal
    Russian Federation
    Slovenia
    Spain
    Sweden
    Switzerland
    Turkey
    Ukraine
    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
    last patient, last visit (LPLV) occurs or the date at which the last data point required for safety analyses or safety follow up is received for the last patient, whichever occurs later. LPLV for the double blind treatment period is expected to occur 153 weeks after the last patient is enrolled (i.e., 52 weeks after the last dosing visit at week 101)
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 341
    F.4.2.2In the whole clinical trial 750
    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)
    1) Open Label Extension: All eligible patients will have the opportunity to enter an OLE (documented in a separate protocol).
    2) Post-Trial Access to Crenezumab: The Sponsor will offer post-trial access to the study drug (crenezumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product,
    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 Decision2016-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-31
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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