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    Summary
    EudraCT Number:2020-004244-28
    Sponsor's Protocol Code Number:BAN2401-G000-303
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-004244-28
    A.3Full title of the trial
    AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel Treatment Arm, 216 Week Study with an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 clinical study to investigate the effects of BAN2401 in subjects with preclinical Alzheimer's Disease
    A.4.1Sponsor's protocol code numberBAN2401-G000-303
    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 SponsorEisai Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4408456761400
    B.5.5Fax number4408456761486
    B.5.6E-mailLMedInfo@eisai.net
    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 nameBAN2401
    D.3.4Pharmaceutical form 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 INNLecanemab
    D.3.9.1CAS number 1260393-98-3
    D.3.9.4EV Substance CodeSUB216130
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 typeMonoclonal 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
    Preclinical Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Preclinical 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 10066571
    E.1.2Term Progression of Alzheimer's disease
    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
    A45
    To determine whether treatment with BAN2401 is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment.
    A3
    To determine whether treatment with BAN2401 is superior to placebo in reducing brain amyloid accumulation as measured by amyloid PET at 216 weeks of treatment.
    E.2.2Secondary objectives of the trial
    A45
    - To determine whether treatment with BAN2401 is superior to placebo in reducing brain amyloid levels as measured by amyloid positron emission tomography (PET) at 96 and 216 weeks of treatment.
    - To determine whether treatment with BAN2401 is superior to placebo on brain tau pathology as measured by tau PET at 96 and 216 weeks of treatment.
    - To determine whether treatment with BAN2401 is superior to placebo on the change from baseline in the Cognitive Function Index (CFI) at 216 weeks of treatment.
    - To evaluate the safety and tolerability of BAN2401 relative to placebo.
    A3
    - To determine whether treatment with BAN2401 is superior to placebo on brain tau pathology as measured by tau PET at 216 weeks of treatment.
    - To evaluate the safety and tolerability of BAN2401 relative to placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CSF sample will be collected for subjects who consent to participate in the optional longitudinal CSF substudy
    E.3Principal inclusion criteria
    Inclusion Criteria
    1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, CSF, or plasma testing
    a. Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity <65 years:
    i. First degree relative diagnosed with dementia onset before age 75, or (revised per Amendment 01)
    ii. Known to possess at least 1 apolipoprotein є4 variant (APOE4) allele, or
    iii. Known before screening to have elevated brain amyloid according to previous PET or CSF testing.
    2. Global CDR score of 0 at Screening
    3. Mini Mental State Examination (MMSE) score ≥27 (with educational adjustments) at Screening
    4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at Screening of ≥6
    5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: Elevated amyloid is defined as approximately >40 centiloids on Screening scan.
    A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: Intermediate amyloid is defined as approximately 20 to 40 centiloids on Screening scan.
    6. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject’s daily function.
    7. Provide written (or electronic if allowed, per country-specific regulations) informed consent
    8. Willing and able to comply with all aspects of the protocol
    E.4Principal exclusion criteria
    1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive β-hCG or hCG test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). For women of childbearing potential, a separate baseline assessment is required if a negative Screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
    2. Females of childbearing potential who:
    - Within 28 days before study entry, did not use a highly effective method of contraception (see protocol for examples)
    For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide.
    NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age range, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
    3. History of TIA, stroke, or seizures within 12 months of Screening
    4. Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures
    5. Contraindications to 3 Tesla MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (eg, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening, including but not limited to: more than 4 microhemorrhages (defined as 10 mm or less at the greatest diameter); a single macrohemorrhage greater than 10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; cerebral contusion, encephalomalacia, aneurysms greater than 6 mm, or any aneurysms that have not been stable in size for the past 2 years, vascular malformations that are at high risk for hemorrhage, or infective lesions; evidence of multiple lacunar infarcts (that in the opinion of the investigator, may impact cognition), stroke involving a major vascular territory, severe small vessel, or severe diffuse white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary). Other minor or clinically insignificant MRI abnormalities, as agreed by the medical monitor and after discussion with the investigator, may not be exclusionary
    6. Hypersensitivity to any monoclonal antibody treatment
    7. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
    8. Bleeding disorder that is not under adequate control (including a platelet count <50,000 or INR >1.5) at Screening
    9. Results of laboratory tests conducted during Screening that are outside the limits defined in the protocol
    10. Known to be HIV positive
    11. Any other clinically significant abnormalities that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety.
    12. Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male subjects with treatment cycles completed at least 6 months before Screening). Subjects who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
    13. Answer “yes” to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at Baseline, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
    14. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Subjects who test positive for benzodiazepines, opioids, or THC in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse
    15. Taking prohibited medications
    16. Participation in a clinical study involving those compounds defined in the protocol.
    17. Planned surgery during the Prerandomization Phase or within 3 months of Randomization, which requires general anesthesia
    E.5 End points
    E.5.1Primary end point(s)
    A45
    Change from baseline in PACC5 at 216 weeks.

    A3
    Change from baseline in amyloid PET SUVr at 216 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A45
    At 216 weeks

    A3
    At 216 weeks
    E.5.2Secondary end point(s)
    A45
    - Change from baseline in amyloid PET standard uptake value ratio (SUVr) at 96 and 216 weeks
    - Change from baseline in tau PET SUVr at 96 and 216 weeks.
    - Change from baseline in CFI at 216 weeks.

    A3
    - Change from baseline in tau PET SUVr at 216 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A45
    At weeks 96 and 216

    A3
    At 216 weeks
    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 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 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 Yes
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Singapore
    Australia
    Canada
    Japan
    United Kingdom
    United States
    Spain
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months6
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1120
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 1400
    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)
    A subject may elect to discontinue the study at any time for any reason. Subjects who discontinue early must comply with the ET Visit and the Follow-up Visit (12 weeks after the last dose of study drug). See protocol section 9.5.5. for full details.
    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 Decision2022-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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