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    Summary
    EudraCT Number:2017-002702-12
    Sponsor's Protocol Code Number:BN40031
    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:2018-12-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-002702-12
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION OF PHASE III STUDIES (BN29552/BN29553) OF CRENEZUMAB IN PATIENTS WITH ALZHEIMER’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CREAD Open Label Extension: A Study of Crenezumab to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
    A.4.1Sponsor's protocol code numberBN40031
    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 code4070
    B.5.3.4CountrySwitzerland
    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
    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
    AD is a chronic neurodegenerative disease that destroys memory and other important mental functions
    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
    T-o assess the long-term safety and tolerability of crenezumab (60 mg/kg IV Q4W) in eligible patients with AD who participated in Study BN29552 or BN29553 and completed the Week 105 study visit.
    E.2.2Secondary objectives of the trial
    For exploratory efficacy objectives, the study aims to evaluate the long-term effect of crenezumab on global outcomes of disease progression, cognition, disease severity, patient dependence, patient function, patient behaviour and neuropsychological symptoms, health-related quality of life, and effect on caregiver burden.
    For exploratory pharmacokinetic objectives, the study aims to evaluate PK characteristics of crenezumab and to explore exposure-response relationships in patients with prodromal to mild Alzheimer’s disease.
    For exploratory biomarker objectives, the study aims to evaluate the effect of crenezumab on biomarkers.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Amyloid-PET Longitudinal Substudy & Tau-PET Longitudinal Substudy included in the main protocol V1 dated 18.Sept 2017
    E.3Principal inclusion criteria
    •Previous participation in Study BN29552 or BN29553 and completion of the Week 105 visit
    •Able to provide written consent signed by the patient or the patient’s authorized representative under applicable local law
    •A caregiver, defined as:
    –Has frequent and sufficient contact with the patient to be able to provide accurate information regarding the patient’s cognitive and functional abilities
    –Be in sufficiently good general health
    •Willingness and ability to complete all aspects of the study
    •Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing
    •For women of childbearing potential: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 8 weeks after the final dose of study drug
    •For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for at least 8 weeks after the final dose of study drug to avoid exposing the embryo
    E.4Principal exclusion criteria
    •Patients who discontinued treatment permanently in Study BN29552 or BN29553 for safety reasons
    •Impaired coagulation
    •Evidence of more than 10 microbleeds and/or ARIA-H at the Study BN29552 or BN29553 Week 105 visit, as assessed by central review of MRI
    •Diagnosed with three recurrent, symptomatic ARIA-E events or exacerbations of previous events
    •Presence of intracranial lesion that could potentially increase the risk of CNS bleeding (e.g., intracranial aneurysm; arterio-venous malformation)
    •At risk of suicide in the opinion of the investigator
    •Alcohol and/or substance abuse or dependence (according to Diagnostic and Statistical Manual of Mental Disorders Version 5 criteria) within the past 2 years and during the study (nicotine use is allowed; marijuana use is not allowed within the past 2 years)
    •Inability to tolerate MRI procedures or contraindication to MRI
    •Pregnant or lactating, or intending to become pregnant during the study
    •Any other severe or unstable medical condition that, in the opinion of the investigator or Sponsor, could be expected to progress, recur, or change
    •Chronic use of anticoagulants or participation in any other investigational drug treatment trial
    E.5 End points
    E.5.1Primary end point(s)
    1.Nature, frequency, severity, and timing of adverse events and serious adverse events
    2.Incidence of adverse events of special interest, specifically pneumonia
    3.Changes in vital signs, clinical laboratory tests, Electrocardiogram assessments from baseline over time
    4.Changes in Columbia-Suicide Severity Rating Scale (CSSR-S) scores from baseline over time
    5.Adverse events as assessed by MRI: amyloid-related imaging abnormalities edema/effusion and ARIA H
    6.Incidence of immunogenicity as evidenced by antibodies to crenezumab or other components of drug product
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 4 years
    3. From baseline up to 4 years
    4. From baseline, OLE Weeks 25, 53, 77, 105 and every 52 weeks thereafter and follow-up for patients discontinuing OLE and completing OLE treatment
    5. At Weeks 13, 25, 53, 105, and every 52 weeks thereafter and follow-up for patients discontinuing OLE and completing OLE treatment
    6. OLE Weeks 1, 13, 25, 53, 105 and every 52 weeks thereafter, follow-up for patients discontinuing OLE and completing OLE treatment
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    PET Ligand (florbetapir F18)
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA184
    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
    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 OLE study will continue until crenezumab is commercially available in the patient’s
    country,as per local regulation,or should the Sponsor decide to terminate the program
    for pAD to mAD. However,all patients will have the opportunity to complete
    approx.2 years of treatment even if crenezumab is commercially available in the
    country.The study will not exceed approx.2 years after the last patient
    enrolled during the global enrollment phase (in BN29552orBN29553) enters
    the OLE study.
    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 months8
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-12-18. Yes
    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
    decline in Alzheimer’s Disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 351
    F.4.2.2In the whole clinical trial 1125
    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 post-trial access to the Roche IMP (crenezumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product (see Protocol section 4.3.4)
    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 Decision2018-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-31
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