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    Summary
    EudraCT Number:2016-000108-27
    Sponsor's Protocol Code Number:H8A-MC-LZBE
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000108-27
    A.3Full title of the trial
    A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study
    of Efficacy and Safety of Solanezumab versus Placebo in
    Prodromal Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase 3 study designed to test whether drug product will slow disease progression in patients with mild memory problems (prodromal Alzheimer's disease).
    A.3.2Name or abbreviated title of the trial where available
    A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO
    A.4.1Sponsor's protocol code numberH8A-MC-LZBE
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis, Indiana
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 name solanezumab
    D.3.2Product code LY2062430
    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.3.9.1CAS number 955085-14-0
    D.3.9.2Current sponsor codeLY2062430
    D.3.9.3Other descriptive nameSOLANEZUMAB
    D.3.9.4EV Substance CodeSUB37126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Prodromal Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    Medical condition in which an individual's memory, thinking, judgment, and gradually their ability to function is lost.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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 assess the hypothesis that solanezumab 400 mg
    Q4W will slow the clinical progression of prodromal
    AD over 24 months compared to placebo
    E.2.2Secondary objectives of the trial
    To assess the effect of solanezumab vs. placebo on the clinical
    progression of prodromal AD over 24 months
    To assess the effect of solanezumab vs. placebo on quality of life and
    health outcomes in prodromal AD over 24 months
    To assess the effect of solanezumab vs. placebo on biomarkers in
    prodromal AD over 24 months
    To assess the hypothesis that change from baseline in accumulation of
    tau pathology over 12 and 24 months is associated with changes from
    baseline in cognition
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum H8A-MC-LZBE(1)
    (18F-AV-1451 tau imaging)
    A 24-Month, Phase 3, Multicenter, Placebo-Controlled
    Study of Efficacy and Safety of Solanezumab versus
    Placebo in Prodromal Alzheimer’s Disease. 28Mar2016. Objectives: To assess the hypothesis that solanezumab will slow
    the accumulation of tau pathology over 12 and 24
    months compared to placebo; To assess the hypothesis that change from baseline in
    accumulation of tau pathology over 12 and 24
    months is associated with changes from baseline in
    cognition; and To assess the hypothesis that change from baseline in
    accumulation of tau pathology over 24 months is
    associated with changes from baseline in function.

    Protocol Addendum H8A-MC-LZBE(2) (LP)
    A 24-Month, Phase 3, Multicenter, Placebo-Controlled
    Study of Efficacy and Safety of Solanezumab versus
    Placebo in Prodromal Alzheimer’s Disease. 28Mar2016. Objectives: Lumbar punctures (LPs) will be used to collect cerebrospinal fluid (CSF) for assays of
    solanezumab, amyloid beta (AB) species, and tau proteins (as described in this addendum); and
    for CSF storage.
    E.3Principal inclusion criteria
    •Has a diagnosis by the study investigator of a clinical syndrome of
    cognitive impairment consistent with prodromal AD per International
    Working Group (IWG) diagnostic criteria or MCI due to AD per National
    Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
    •Has evidence of amyloid pathology by PET imaging or lumbar puncture CSF
    •Scores 17-28 on MoCA at screening.
    •Scores <27 on free recall cutoff score from the FCSRT (Picture
    version) at screening.
    •Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
    •Scores >0 on the FAQ.
    •Has a florbetapir PET scan or CSF result at screening consistent with
    the presence of amyloid pathology.
    E.4Principal exclusion criteria
    •Has had MRI or computerized tomography (CT) of brain within previous
    2 years showing pathology that would be inconsistent with a diagnosis
    of AD.
    •Has known allergy to humanized monoclonal antibodies.
    •Has an ongoing clinically significant laboratory abnormality, as
    determined by the investigator.
    •Has screening MRI with results showing >4 amyloid related imaging
    abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
    •Has any contraindications for MRI studies, including claustrophobia, the
    presence of metal (ferromagnetic) implants, or a cardiac pacemaker that
    is not compatible with MRI.
    •Has received treatment with a stable dose of an achetylcholinesterase
    (AChEI)inhibitor or memantine for less than 2 months before
    randomization. (If a participant has recently stopped AChEIs and/or
    memantine, he or she must have discontinued treatment at least 2
    months before randomization.)
    E.5 End points
    E.5.1Primary end point(s)
    Alzheimer´s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 24 months
    E.5.2Secondary end point(s)
    Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCIADL); Mini Mental Status Examination (MMSE); Montreal Cognitive Assessment (MoCA); Functional Activities Questionnaire (FAQ); Neuropsychiatric Inventory (NPI); Clinical Dementia Rating Scale Sum of Boxes (CDR-SB); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); Free and Cued Selective Reminding Test
    (FCSRT); Resource Utilization in Dementia-Lite (RUD-Lite); EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D); Quality of Life in Alzheimer's Disease Scale (QoL-AD); Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab; Volumetric Magnetic Resonance Imaging (vMRI); Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr); Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins; Pharmacogenomics Markers
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 24 months
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Belgium
    Canada
    China
    Finland
    France
    Germany
    Italy
    Japan
    Korea, Democratic People's Republic of
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 1225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1225
    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
    Those with rapid disease progression making later reconsents an issue. All will be able to consent at entry into the trial, but a rapid decline in cognition (which would be unexpected in this population) might be a risk.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 828
    F.4.2.2In the whole clinical trial 1622
    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)
    None
    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 Decision2016-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-08
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