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    Clinical Trial Results:
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study of Lu AG09222 for the prevention of migraine in patients with unsuccessful prior preventive treatments

    Summary
    EudraCT number
    		 2020-005924-12
    Trial protocol
    		 SK   CZ   DK   PL  
    Global end of trial date
    16 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2024
    First version publication date
    27 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    19678A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05133323
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    Email contact via, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@Lundbeck.com
    Scientific contact
    Email contact via, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@Lundbeck.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
    16 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to evaluate the efficacy of Lu AG09222 for the prevention of migraine in participants with unsuccessful prior preventive treatments.
    Protection of trial subjects
    This study was designed in accordance with the Declaration of Helsinki. This study was conducted in compliance with the protocol, Good Clinical Practice, and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2021
    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
    Czechia: 52
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Georgia: 86
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Slovakia: 23
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    237
    EEA total number of subjects
    146
    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)
    235
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 237 participants were enrolled in 6 countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lu AG09222 High Dose
    Arm description
    		 Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lu AG09222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a single dose by IV infusion

    Arm title
    		 Lu AG09222 Low Dose
    Arm description
    		 Participants received a single dose of Lu AG09222 by IV infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lu AG09222
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a single dose by IV infusion

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single dose of placebo matching to Lu AG09222 by 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
    Participants received a single dose of Lu AG09222-matching placebo (0.9% saline solution) by IV infusion.

    Number of subjects in period 1
    		Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
    Started
    97
    46
    94
    Received at least 1 dose of study drug
    97
    46
    94
    Completed
    95
    45
    93
    Not completed
    2
    1
    1
         Consent withdrawn by subject
    2
    1
    -
         Lack of efficacy
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lu AG09222 High Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.

    Reporting group title
    Lu AG09222 Low Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by IV infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.

    Reporting group values
    		 Lu AG09222 High Dose Lu AG09222 Low Dose Placebo Total
    Number of subjects
    		 97 46 94 237
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 95 46 94 235
        From 65-84 years
    		 2 0 0 2
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.5 ( 9.88 ) 42.5 ( 9.35 ) 42.5 ( 9.51 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 89 38 81 208
        Male
    		 8 8 13 29
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 97 46 94 237
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Lu AG09222 High Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.

    Reporting group title
    Lu AG09222 Low Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by IV infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.

    Primary: Change From Baseline in the Number of Monthly Migraine Days (MMDs)

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    End point title
    		 Change From Baseline in the Number of Monthly Migraine Days (MMDs)
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that: • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura), • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine), • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication. The all participants treated set (APTS) represents all randomized participants who received an infusion of investigational medicinal product.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
    Number of subjects analysed
    97
    46
    94
    Units: days
        least squares mean (standard error)
    -6.2 ( 0.66 )
    -6.0 ( 0.94 )
    -4.2 ( 0.67 )
    Statistical analysis title
    		 Change from Baseline in Monthly Migraine Days
    Comparison groups
    Lu AG09222 High Dose v Placebo
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0106
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89

    Secondary: Change From Baseline in the Number of Monthly Headache Days (MHDs)

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    End point title
    		 Change From Baseline in the Number of Monthly Headache Days (MHDs)
    End point description
    A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day. The APTS represents all randomized participants who received an infusion of investigational medicinal product.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
    Number of subjects analysed
    96
    44
    93
    Units: days
        least squares mean (standard error)
    -5.8 ( 0.65 )
    -5.9 ( 0.93 )
    -4.1 ( 0.67 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs

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    End point title
    		 Percentage of Participants With ≥50% Reduction From Baseline in MMDs
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that: • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura), • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine), • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication. The APTS represents all randomized participants who received an infusion of investigational medicinal product.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
    Number of subjects analysed
    97
    46
    94
    Units: percentage of participants
        number (not applicable)
    32.2
    36.1
    26.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks
    Adverse event reporting additional description
    The APTS represents all randomized participants who received an infusion of investigational medicinal product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Lu AG09222 High Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.

    Reporting group title
    Lu AG09222 Low Dose
    Reporting group description
    		 Participants received a single dose of Lu AG09222 by IV infusion.

    Serious adverse events
    		 Lu AG09222 High Dose Placebo Lu AG09222 Low Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 94 (0.00%)
    0 / 46 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Sympathetic Posterior Cervical Syndrome
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 94 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lu AG09222 High Dose Placebo Lu AG09222 Low Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 97 (18.56%)
    8 / 94 (8.51%)
    4 / 46 (8.70%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 97 (5.15%)
    1 / 94 (1.06%)
    2 / 46 (4.35%)
         occurrences all number
    5
    1
    2
    Infections and infestations
    Covid-19
         subjects affected / exposed
    7 / 97 (7.22%)
    3 / 94 (3.19%)
    2 / 46 (4.35%)
         occurrences all number
    7
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    7 / 97 (7.22%)
    4 / 94 (4.26%)
    0 / 46 (0.00%)
         occurrences all number
    7
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2022
    Updated exploratory objectives and clarified inclusion/exclusion criteria.
    11 Jul 2022
    Deleted all descriptions of and references to the non-binding interim analysis for futility, as decision was taken not to conduct an interim analysis.

    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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