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    Clinical Trial Results:
    An Extension Study of ABBV-8E12 in Early Alzheimer's Disease

    Summary
    EudraCT number
    		 2018-000268-26
    Trial protocol
    		 ES   FI   BE   DK   NL   IT  
    Global end of trial date
    30 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2022
    First version publication date
    10 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M15-570
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03712787
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road,, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early Alzheimer's Disease (AD).
    Protection of trial subjects
    Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 26
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    New Zealand: 11
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    United States: 222
    Worldwide total number of subjects
    364
    EEA total number of subjects
    86
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    43
    From 65 to 84 years
    308
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 364 participants who had completed the parent study (Study M15-566; NCT02880956) were enrolled into this extension study from a total of 57 sites in the United States, Australia, Belgium, Canada, Denmark, Finland, Italy, New Zealand, Spain, and Sweden.

    Pre-assignment
    Screening details
    		 Prior to enrollment, 87 participants had received tilavonemab 300 mg, 97 participants had received tilavonemab 1000 mg, 88 participants had received tilavonemab 2000 mg, and 92 participants had received placebo in the parent study.

    Pre-assignment period milestones
    Number of subjects started
    		 364
    Number of subjects completed
    		 363

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Enrolled but not treated: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 300 mg/1000 mg Tilavonemab
    Arm description
    		 Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tilavonemab
    Investigational medicinal product code
    ABBV-8E12
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive study drug infusion every 4 weeks.

    Arm title
    		 1000 mg/1000 mg Tilavonemab
    Arm description
    		 Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tilavonemab
    Investigational medicinal product code
    ABBV-8E12
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive study drug infusion every 4 weeks.

    Arm title
    		 2000 mg/2000 mg Tilavonemab
    Arm description
    		 Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tilavonemab
    Investigational medicinal product code
    ABBV-8E12
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive study drug infusion every 4 weeks.

    Arm title
    		 PBO/2000 mg Tilavonemab
    Arm description
    		 Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tilavonemab
    Investigational medicinal product code
    ABBV-8E12
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to receive study drug infusion every 4 weeks.

    Number of subjects in period 1 [1]
    		300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Started
    87
    97
    88
    91
    Completed
    0
    0
    0
    0
    Not completed
    87
    97
    88
    91
         Consent withdrawn by subject
    4
    14
    12
    8
         Adverse Event
    2
    3
    -
    4
         COVID-19 Logistical Restrictions
    1
    1
    -
    -
         COVID-19 Infection
    -
    1
    -
    -
         Lost to follow-up
    1
    1
    2
    1
         Other, Not Specified
    79
    77
    74
    78
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 enrolled subject did not received any treatment, and is accounted for in the Pre-Assignment table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    300 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks.

    Reporting group title
    1000 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    2000 mg/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    PBO/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.

    Reporting group values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab Total
    Number of subjects
    		 87 97 88 91 363
    Age categorical
    Units: Subjects
        < 65 years
    		 8 11 14 10 43
        >= 65 years
    		 79 86 74 81 320
    Gender categorical
    Units: Subjects
        Female
    		 39 48 48 56 191
        Male
    		 48 49 40 35 172
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 1
        Asian
    		 2 0 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 0 1
        Black or African American
    		 3 1 0 2 6
        White
    		 81 94 86 89 350
        More than one race
    		 0 1 2 0 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 5 4 3 4 16
        None
    		 82 93 85 87 347

    End points

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    End points reporting groups
    Reporting group title
    300 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks.

    Reporting group title
    1000 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    2000 mg/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    PBO/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.

    Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs [1]
    End point description
    Treatment emergent adverse events (TEAEs) are defined as any adverse event from the time of study drug administration until 20 weeks after discontinuation of study drug. An adverse event (AE) is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility. Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.
    End point type
    Primary
    End point timeframe
    From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Number of subjects analysed
    87
    97
    88
    91
    Units: participants
        Any TEAE
    54
    66
    59
    57
        Severe TEAE
    9
    8
    10
    7
        TEAE With a Reasonable Possibility of Relationship
    7
    10
    15
    5
        Serious TEAE
    16
    11
    12
    10
        TEAE Leading to Discontinuation of Study Drug
    2
    4
    0
    5
        Fatal TEAE
    1
    1
    1
    0
    No statistical analyses for this end point

    Primary: Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values

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    End point title
    		 Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values [2]
    End point description
    Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. ULN=upper limit of normal. Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.
    End point type
    Primary
    End point timeframe
    Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Number of subjects analysed
    87
    97
    88
    91
    Units: participants
        Hemoglobin - Low (< 100 g/L)
    1
    0
    2
    1
        Hemoglobin - High (> 40 g/L above ULN)
    0
    0
    0
    0
        Platelets - Low (< 75 × 10^9/L)
    0
    0
    0
    0
        Leukocytes - Low (< 2 × 10^9/L)
    0
    0
    0
    0
        Leukocytes - High (> 100 × 10^9/L)
    0
    0
    0
    0
        Neutrophils - Low (< 1 × 10^9/L)
    1
    0
    0
    0
        Lymphocytes - Low (< 0.5 × 10^9/L)
    0
    0
    1
    0
        Lymphocytes - High (> 20 × 10^9/L)
    0
    0
    0
    0
        Activated Partial Thromboplastin Time (> ULN)
    0
    0
    0
    0
        Prothrombin International Normalized Ratio (> ULN)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values

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    End point title
    		 Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values [3]
    End point description
    Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03. Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.
    End point type
    Primary
    End point timeframe
    Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Number of subjects analysed
    87
    97
    88
    91
    Units: participants
        Alanine Aminotransferase (> 3 × ULN)
    0
    0
    0
    0
        Aspartate Aminotransferase (> 3 × ULN)
    0
    0
    0
    0
        Alkaline Phosphatase (> 2.5 × ULN)
    0
    0
    0
    0
        Bilirubin (> 1.5 × ULN)
    0
    0
    1
    1
        Creatinine (> 1.5 × ULN)
    0
    0
    0
    0
        Calcium - Low (< 1.75 mmol/L)
    0
    0
    0
    0
        Calcium - High (> 3.1 mmol/L)
    0
    0
    0
    0
        Sodium - Low (< 130 mmol/L)
    0
    1
    0
    1
        Sodium - High (> 155 mmol/L)
    0
    0
    0
    0
        Potassium - Low (< 3 mmol/L)
    0
    0
    0
    0
        Potassium - High (> 6 mmol/L)
    0
    0
    0
    0
        Glucose - Low (< 2.2 mmol/L)
    0
    0
    0
    0
        Glucose - High (> 13.9 mmol/L)
    0
    0
    0
    1
        Albumin (< 20 g/L)
    0
    0
    0
    0
        Cholesterol (> 12.92 mmol/L)
    0
    0
    0
    0
        Triglycerides (> 5.7 mmol/L)
    0
    0
    1
    0
        Phosphate (< 0.6 mmol/L)
    0
    0
    0
    0
        Uric acid (> 590 μmol/L)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period

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    End point title
    		 Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period [4]
    End point description
    The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide. Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570.
    End point type
    Primary
    End point timeframe
    Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Number of subjects analysed
    87
    97
    88
    91
    Units: participants
        Suicidal behaviors or ideations
    4
    3
    8
    4
        Suicidal behaviors
    0
    0
    0
    0
        Suicidal ideations
    4
    3
    8
    4
        Suicidal ideations only (no suicidal behavior)
    4
    3
    8
    4
    No statistical analyses for this end point

    Primary: Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease

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    End point title
    		 Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease [5]
    End point description
    Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. Participants with postbaseline value for the respective parameter.
    End point type
    Primary
    End point timeframe
    Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab PBO/2000 mg Tilavonemab
    Number of subjects analysed
    79
    84
    79
    78
    Units: participants
        Cerebral Edemas
    1
    1
    0
    0
        Questionable Cerebral Edemas
    0
    1
    0
    0
        New Microhemorrhage(s)
    4
    5
    11
    5
        Severe White Matter Disease
    9
    5
    6
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    300 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    1000 mg/1000 mg Tilavonemab
    Reporting group description
    		 Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    PBO/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.

    Reporting group title
    2000 mg/2000 mg Tilavonemab
    Reporting group description
    		 Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.

    Serious adverse events
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab PBO/2000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 87 (18.39%)
    11 / 97 (11.34%)
    10 / 91 (10.99%)
    12 / 88 (13.64%)
         number of deaths (all causes)
    2
    1
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLADDER TRANSITIONAL CELL CARCINOMA
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COLON CANCER
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COLORECTAL ADENOCARCINOMA
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MALIGNANT MELANOMA
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSITIONAL CELL CARCINOMA
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    AORTIC STENOSIS
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE PULMONARY OEDEMA
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY OEDEMA
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    AGGRESSION
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BEHAVIOUR DISORDER
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 97 (2.06%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROCEDURAL INTESTINAL PERFORATION
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SOFT TISSUE INJURY
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ANGINA UNSTABLE
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ARRHYTHMIA
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CARDIOPULMONARY FAILURE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEMENTIA
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEIZURE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VESTIBULAR DISORDER
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    RETINAL ARTERY OCCLUSION
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS ISCHAEMIC
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    BILIARY COLIC
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHRONIC KIDNEY DISEASE
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 PNEUMONIA
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    CYSTITIS ESCHERICHIA
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ENTEROCOCCAL INFECTION
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA LEGIONELLA
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 97 (0.00%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FAILURE TO THRIVE
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    0 / 91 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 300 mg/1000 mg Tilavonemab 1000 mg/1000 mg Tilavonemab PBO/2000 mg Tilavonemab 2000 mg/2000 mg Tilavonemab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 87 (29.89%)
    37 / 97 (38.14%)
    26 / 91 (28.57%)
    33 / 88 (37.50%)
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    2 / 87 (2.30%)
    6 / 97 (6.19%)
    0 / 91 (0.00%)
    1 / 88 (1.14%)
         occurrences all number
    2
    8
    0
    1
    FALL
         subjects affected / exposed
    10 / 87 (11.49%)
    10 / 97 (10.31%)
    10 / 91 (10.99%)
    12 / 88 (13.64%)
         occurrences all number
    14
    12
    13
    16
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    2 / 87 (2.30%)
    5 / 97 (5.15%)
    0 / 91 (0.00%)
    5 / 88 (5.68%)
         occurrences all number
    2
    5
    0
    6
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    5 / 87 (5.75%)
    2 / 97 (2.06%)
    2 / 91 (2.20%)
    2 / 88 (2.27%)
         occurrences all number
    5
    2
    3
    2
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    5 / 87 (5.75%)
    5 / 97 (5.15%)
    1 / 91 (1.10%)
    3 / 88 (3.41%)
         occurrences all number
    5
    6
    1
    3
    Psychiatric disorders
    AGITATION
         subjects affected / exposed
    1 / 87 (1.15%)
    6 / 97 (6.19%)
    0 / 91 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    1
    6
    0
    3
    ANXIETY
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 97 (1.03%)
    3 / 91 (3.30%)
    7 / 88 (7.95%)
         occurrences all number
    3
    1
    3
    8
    CONFUSIONAL STATE
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 97 (2.06%)
    5 / 91 (5.49%)
    4 / 88 (4.55%)
         occurrences all number
    1
    2
    6
    4
    DELUSION
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 97 (1.03%)
    2 / 91 (2.20%)
    5 / 88 (5.68%)
         occurrences all number
    0
    1
    2
    5
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 97 (2.06%)
    2 / 91 (2.20%)
    6 / 88 (6.82%)
         occurrences all number
    1
    2
    2
    6
    BACK PAIN
         subjects affected / exposed
    5 / 87 (5.75%)
    4 / 97 (4.12%)
    5 / 91 (5.49%)
    3 / 88 (3.41%)
         occurrences all number
    6
    4
    7
    3
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    4 / 87 (4.60%)
    8 / 97 (8.25%)
    1 / 91 (1.10%)
    0 / 88 (0.00%)
         occurrences all number
    10
    8
    3
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2019
    ● Update Section 1.0, Title Page, to add sponsor contact. ● Update Section 5.3.1.1, Study Procedures, to add instructions for ECG collection and made editorial changes for clarity. ● Update Section 5.5.1, Treatments Administered, to add visit window and allow faster rates for infusion. ● Update Section 5.5.2.2, Storage and Disposition of Study Drugs, to revise language on storage temperature excursion. ● Update Section 7.0, Protocol Deviations, to update the names and information for sponsor clinical personnel. ● Update Section 9.3, Subject Information and Consent, to change the location of storage of subject informed consent from medical record to study record. ● Update Appendix C, Study Activities, to correct typographical errors, clarify previous text, and clarify retinal imaging scan language. ● Added Appendix E, Protocol Amendment: List of Changes, to describe changes made with this amendment.
    20 Oct 2020
    ● Update Section 3.0 Introduction Clinical Experience to remove studies. ● Update Section 3.2 Benefits and Risks to include language for the coronavirus disease-19 (COVID-19) pandemic. ● Update Section 5.1 Overall Study Design and Plan: Description to specify timing in schedule of activities. ● Update Section 5.2.2 Exclusion Criteria to add a rationale for the exclusion criteria. ● Update Section 5.3.1.1 Study Procedures [Physical Examination, Neurological Examination, Vital Signs, 12-Lead Electrocardiogram (ECG), Abnormal Findings, Optional Lumbar Puncture, Magnetic Resonance Imaging (MRI), and Positron Emission Tomography (PET) Tau Imaging] to include language for the COVID-19 pandemic. ● Update Section 5.3.1.1 Study Procedures, Table 2 to specify optional tests. ● Update Section 5.3.1.1 Study Procedures [Positron Emission Tomography (PET) Tau Imaging] to specify timing in schedule of activities. ● Update Section 5.3.1.1 Study Procedures to remove procedures. ● Update Section 5.3.1.1 Study Procedures, Table 3 to specify timing of scales. ● Update Section 5.3.1.1 Study Procedures, EuroQuality of Life-5-level (EQ-5D5L) to add language describing the scale. ● Update Section 5.3.1.2 Collection and Handling of Biomarker and Pharmacogenetic Research Samples (Blood and Optional CSF Biomarker Samples; Optional Pharmacogenetic Research Samples) to include language for the COVID19 pandemic. ● Update Section 5.3.2.1 Collection of Samples for Analysis (Optional CSF Samples for ABBV-8E12 Assay) to include language for the COVID-19 pandemic. ● Update Section 5.3.6.1 Biomarker Research Variables, Volumetric MRI to include language reflecting analysis. ● Update Section 5.3.6.1 Biomarker Research Variables to remove language. ● Update Section 5.4.1 Discontinuation of Individual Subjects to include language for the COVID-19 pandemic. ● Update Section 5.5.1 Treatments Administered to specify timing of drug administration.
    20 Oct 2020
    (continued) Update Section 5.5.2 Identity of Investigational Product, Table 4 to add additional strength of study drug ● Update Section 6.1.5 Adverse Event Reporting to include language for the COVID-19 pandemic. ● Update Section 8.1.1 Analysis Data Sets, Data Set for Safety Analyses to remove language pertaining to analysis. ● Update Section 8.1.1 Analysis Data Sets, Data Set for Biomarkers to include language pertaining to analysis. ● Update Section 8.1.4 Safety Analysis to include language pertaining to analyses. ● Update Section 8.1.4.2 Analysis of Adverse Events to include language pertaining to analyses. ● Update Section 8.1.5 Biomarker Analyses to include language pertaining to analysis. ● Update Section 8.1.5 Biomarker Analyses, Volumetric MRI Variables to include language pertaining to analysis. ● Update Section 9.2 Ethical Conduct of the Study to include language for the COVID-19 pandemic. ● Update Section 9.3 Subject Information and Consent to include language for the COVID-19 pandemic. ● Update Section 11.0 Data Quality Assurance to include language for the COVID19 pandemic. ● Update Section 15.0 Reference List to replace reference.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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