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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

    Summary
    EudraCT number
    		 2019-003753-29
    Trial protocol
    		 ES  
    Global end of trial date
    23 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Nov 2025
    First version publication date
    28 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M19-148
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04309474
    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, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 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
    23 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study was to assess the efficacy, safety, tolerability, and PK of elezanumab in subjects with Acute Ischemic Stroke (AIS).
    Protection of trial subjects
    Prior to any study-related screening procedures being performed on the subject or any medications being discontinued by the subject in order to participate in this study, the informed consent statement will be reviewed, signed, and dated by the subject or their legally authorized representative, the person who administered the informed consent, and any other signatories according to local requirements. A copy of the signed informed consent will be given to the subject and the original will be placed in the subject's medical record.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 2020
    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: 4
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Spain: 33
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    121
    EEA total number of subjects
    33
    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)
    40
    From 65 to 84 years
    72
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 121 subjects were randomized at 30 sites in 6 countries: Australia, Canada, Japan, South Korea, Spain, and the US, and 119 subjects received study treatment. Eighty of 121 randomized subjects completed study treatment.

    Period 1
    Period 1 title
    Overall Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants will receive placebo for elezanumab via Intravenous (IV) infusion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The solution contained in the study vial(s) will be diluted in 250 mL of 0.9% Sodium Chloride Injection/Solution for Infusion. Study drug will be administered intravenously every 4 weeks through Week 48 for a total of 13 doses.

    Arm title
    		 Elezanumab
    Arm description
    		 Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elezanumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The solution contained in the study vial(s) will be diluted in 250 mL of 0.9% Sodium Chloride Injection/Solution for Infusion. Study drug will be administered intravenously every 4 weeks through Week 48 for a total of 13 doses. Total dose is 1800 mg.

    Number of subjects in period 1 [1]
    		Placebo Elezanumab
    Started
    60
    59
    Completed
    39
    41
    Not completed
    21
    18
         Consent withdrawn by subject
    6
    9
         Adverse event
    4
    1
         Lost to follow-up
    1
    2
         Not disclosed
    10
    6
    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: A total of 121 subjects were randomized for this study, but only 119 subjects received study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo for elezanumab via Intravenous (IV) infusion.

    Reporting group title
    Elezanumab
    Reporting group description
    		 Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.

    Reporting group values
    		 Placebo Elezanumab Total
    Number of subjects
    		 60 59 119
    Age categorical
    Units: Subjects
        < 70 years
    		 27 25 52
        70 to < 80 years
    		 18 19 37
        ≥ 80 years
    		 15 15 30
    Gender categorical
    Units: Subjects
        Female
    		 32 24 56
        Male
    		 28 35 63
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 5 12
        Not Hispanic or Latino
    		 53 54 107
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 9 10 19
        Black or African American
    		 4 4 8
        White
    		 46 45 91
        More than one race
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo for elezanumab via Intravenous (IV) infusion.

    Reporting group title
    Elezanumab
    Reporting group description
    		 Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.

    Primary: National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period

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    End point title
    		 National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
    End point description
    The National Institutes of Health Stroke Scale (NIHSS) is a neurological examination used to quantitatively measure the severity of acute stroke by evaluating impact of cerebral infarction on level of consciousness, gaze, visual field, facial palsy, motor ability of arm and leg, limb ataxia, sensation, language, dysarthria, and extinction/inattention. Domains are scored on a scale of 0 to 2, 0 to 3, or 0 to 4, for a total range of 0 -42 points with higher scores indicating impairment.
    End point type
    Primary
    End point timeframe
    Day 1 through Week 52
    End point values
    		 Placebo Elezanumab
    Number of subjects analysed
    60
    59
    Units: Area under the curve (AUC)
        number (confidence interval 95%)
    3.83 (2.642 to 5.024)
    3.13 (1.938 to 4.317)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    AUC analyses based on trapezoidal rule using contrast derived from MMRM with stratification factors, treatment, visit, and a treatment by visit interaction included in the model. Posterior probability that the difference in AUC exceeds 0.6 = 0.557
    Comparison groups
    Elezanumab v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Area under the curve (AUC)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.764
         upper limit
    		 2.175
    Notes
    [1] - A statistical test was not performed.

    Secondary: Responder Status based on Modified Rankin Scale (mRS)

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    End point title
    		 Responder Status based on Modified Rankin Scale (mRS)
    End point description
    The mRS is used to assess participant's disability and functional dependence. It is a 6-point scale ranging from 0 (no symptoms) to 5 (severe disability), with additional rating of 6 if the participant is deceased.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo Elezanumab
    Number of subjects analysed
    46 [2]
    38 [3]
    Units: participants
    28
    29
    Notes
    [2] - N indicates the number of subjects with non-missing values at each time point.
    [3] - N indicates the number of subjects with non-missing values at each time point.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Point estimate for responder rate (defined as having an mRS score of 0, 1, or 2), odds ratio and 95% confidence intervals based on a generalized linear mixed model (GLMM).
    Comparison groups
    Placebo v Elezanumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Odds Ratio of LS Means
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 4.24
    Notes
    [4] - A statistical test was not performed.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 608.5 and 607 days for Placebo and Elezanumab 1800 mg, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Elezanumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Elezanumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 61 (29.51%)
    23 / 60 (38.33%)
         number of deaths (all causes)
    1
    7
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    MYELOPROLIFERATIVE NEOPLASM
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HAEMATOMA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHENIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUCOSAL DRYNESS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE PULMONARY OEDEMA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DELIRIUM
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    TROPONIN INCREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    3 / 61 (4.92%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR PSEUDOANEURYSM
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    GASTROINTESTINAL ARTERIOVENOUS MALFORMATION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL SEPTAL DEFECT
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    SINUS NODE DYSFUNCTION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC VENTRICULAR THROMBOSIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL THROMBOSIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ACUTE CORONARY SYNDROME
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    APHASIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BASILAR ARTERY THROMBOSIS
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRAIN OEDEMA
         subjects affected / exposed
    0 / 61 (0.00%)
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL HAEMORRHAGE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSARTHRIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FACIAL PARALYSIS
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGIC TRANSFORMATION STROKE
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEMIPARESIS
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACUNAR INFARCTION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARTIAL SEIZURES
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEIZURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOMNOLENCE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    0 / 61 (0.00%)
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAEMIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    RETINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    NEUTROPENIC COLITIS
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CONSTIPATION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    SEPTIC SHOCK
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSEUDOMEMBRANOUS COLITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA STAPHYLOCOCCAL
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    PNEUMONIA
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOPHILUS INFECTION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA BACTERAEMIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS BACTERIAL
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    DIABETES MELLITUS INADEQUATE CONTROL
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALNUTRITION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Elezanumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 61 (80.33%)
    52 / 60 (86.67%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    4 / 61 (6.56%)
    10 / 60 (16.67%)
         occurrences all number
    4
    13
    HYPOTENSION
         subjects affected / exposed
    4 / 61 (6.56%)
    2 / 60 (3.33%)
         occurrences all number
    4
    2
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 60 (5.00%)
         occurrences all number
    1
    3
    OEDEMA PERIPHERAL
         subjects affected / exposed
    1 / 61 (1.64%)
    6 / 60 (10.00%)
         occurrences all number
    1
    6
    PERIPHERAL SWELLING
         subjects affected / exposed
    0 / 61 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    0
    4
    PYREXIA
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 60 (5.00%)
         occurrences all number
    1
    3
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    10 / 61 (16.39%)
    6 / 60 (10.00%)
         occurrences all number
    10
    6
    DEPRESSION
         subjects affected / exposed
    5 / 61 (8.20%)
    3 / 60 (5.00%)
         occurrences all number
    5
    3
    DEPRESSED MOOD
         subjects affected / exposed
    4 / 61 (6.56%)
    3 / 60 (5.00%)
         occurrences all number
    6
    4
    ANXIETY
         subjects affected / exposed
    6 / 61 (9.84%)
    5 / 60 (8.33%)
         occurrences all number
    6
    6
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    5 / 61 (8.20%)
    11 / 60 (18.33%)
         occurrences all number
    7
    15
    SKIN LACERATION
         subjects affected / exposed
    4 / 61 (6.56%)
    3 / 60 (5.00%)
         occurrences all number
    6
    3
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    6 / 61 (9.84%)
    8 / 60 (13.33%)
         occurrences all number
    6
    10
    BRADYCARDIA
         subjects affected / exposed
    1 / 61 (1.64%)
    4 / 60 (6.67%)
         occurrences all number
    1
    5
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    6 / 61 (9.84%)
    3 / 60 (5.00%)
         occurrences all number
    6
    4
    HAEMORRHAGIC TRANSFORMATION STROKE
         subjects affected / exposed
    7 / 61 (11.48%)
    5 / 60 (8.33%)
         occurrences all number
    7
    5
    HEADACHE
         subjects affected / exposed
    7 / 61 (11.48%)
    10 / 60 (16.67%)
         occurrences all number
    8
    11
    SYNCOPE
         subjects affected / exposed
    1 / 61 (1.64%)
    5 / 60 (8.33%)
         occurrences all number
    1
    6
    Eye disorders
    DRY EYE
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 60 (5.00%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    11 / 61 (18.03%)
    13 / 60 (21.67%)
         occurrences all number
    13
    14
    DIARRHOEA
         subjects affected / exposed
    4 / 61 (6.56%)
    4 / 60 (6.67%)
         occurrences all number
    4
    4
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 61 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    3
    NAUSEA
         subjects affected / exposed
    7 / 61 (11.48%)
    4 / 60 (6.67%)
         occurrences all number
    7
    4
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    4 / 61 (6.56%)
    4 / 60 (6.67%)
         occurrences all number
    4
    5
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 61 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    3
    HAEMATURIA
         subjects affected / exposed
    5 / 61 (8.20%)
    1 / 60 (1.67%)
         occurrences all number
    6
    1
    URINARY RETENTION
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 60 (1.67%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    6 / 61 (9.84%)
    8 / 60 (13.33%)
         occurrences all number
    6
    9
    BACK PAIN
         subjects affected / exposed
    3 / 61 (4.92%)
    4 / 60 (6.67%)
         occurrences all number
    3
    4
    PAIN IN EXTREMITY
         subjects affected / exposed
    2 / 61 (3.28%)
    4 / 60 (6.67%)
         occurrences all number
    2
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 61 (8.20%)
    10 / 60 (16.67%)
         occurrences all number
    5
    10
    URINARY TRACT INFECTION
         subjects affected / exposed
    13 / 61 (21.31%)
    11 / 60 (18.33%)
         occurrences all number
    16
    16
    Metabolism and nutrition disorders
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 61 (1.64%)
    5 / 60 (8.33%)
         occurrences all number
    1
    5
    HYPOKALAEMIA
         subjects affected / exposed
    5 / 61 (8.20%)
    5 / 60 (8.33%)
         occurrences all number
    5
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2021
    Version 2.0: The purpose of this version was to improve study execution, correct minor clerical errors and incorporate necessary protocol modifications due to the COVID-19 pandemic. The amendment increased target enrollment and number of sites, clarified monitoring time windows, and expanded Eligibility Criteria to increase upper age limit and allow inclusion of subjects who have undergone endovascular therapy (EVT).
    25 Mar 2022
    Version 3.0: The purpose of this amendment was to clarify screening period and window for administration of study drug, clarify eligibility for EVT subjects, simplify other eligibility criteria, update study design figure, update target proportion of sub-populations of subjects enrolled, correct infusion time, and address other minor typographical errors.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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