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    Clinical Trial Results:
    An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC)

    Summary
    EudraCT number
    		 2020-005752-38
    Trial protocol
    		 DE  
    Global end of trial date
    15 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2023
    First version publication date
    17 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBAF312ADE03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04792567
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    15 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to estimate the proportion of participants (concomitantly treated with siponimod and siponimod treatment break) achieving seroconversion (i.e. having SARS-CoV-2 serum functional antibodies) after receiving a modRNA vaccine.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    39
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All participants screened were enrolled, there were no screen failures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Siponimod - continuous
    Arm description
    		 Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
    Arm type
    		 Experimental

    Investigational medicinal product name
    Siponimod
    Investigational medicinal product code
    BAF312
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg)

    Investigational medicinal product name
    mRNA-1273 vaccine
    Investigational medicinal product code
    mRNA-1273
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 1 month apart

    Investigational medicinal product name
    BNT162 vaccine
    Investigational medicinal product code
    BNT162
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 3 weeks apart

    Arm title
    		 Siponimod- interrupted
    Arm description
    		 Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
    Arm type
    		 Experimental

    Investigational medicinal product name
    Siponimod
    Investigational medicinal product code
    BAF312
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Interrupted treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg)

    Investigational medicinal product name
    mRNA-1273 vaccine
    Investigational medicinal product code
    mRNA-1273
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 1 month apart

    Investigational medicinal product name
    BNT162 vaccine
    Investigational medicinal product code
    BNT162
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 3 weeks apart

    Arm title
    		 DMT or no MS treatment
    Arm description
    		 Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dimethylfumarate, glatirameracetate, interferon, teriflunomide according to respective SmPC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Injection
    Routes of administration
    Other use
    Dosage and administration details
    per clinical routine

    Investigational medicinal product name
    mRNA-1273 vaccine
    Investigational medicinal product code
    mRNA-1273
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 1 month apart

    Investigational medicinal product name
    BNT162 vaccine
    Investigational medicinal product code
    BNT162
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered 3 weeks apart

    Number of subjects in period 1
    		Siponimod - continuous Siponimod- interrupted DMT or no MS treatment
    Started
    17
    4
    20
    Completed
    17
    4
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Siponimod - continuous
    Reporting group description
    		 Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination

    Reporting group title
    Siponimod- interrupted
    Reporting group description
    		 Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination

    Reporting group title
    DMT or no MS treatment
    Reporting group description
    		 Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination

    Reporting group values
    		 Siponimod - continuous Siponimod- interrupted DMT or no MS treatment Total
    Number of subjects
    		 17 4 20 41
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 4 19 39
        From 65-84 years
    		 1 0 1 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ( 5.8 ) 55.8 ( 2.2 ) 48.6 ( 12.9 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 13 3 16 32
        Male
    		 4 1 4 9
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 14 3 17 34
        African
    		 0 0 0 0
        Other
    		 1 1 2 4
        Missing
    		 2 0 1 3
    Multiple sclerosis diagnosis
    The diagnosis of type of multiple sclerosis (MS) at baseline.
    Units: Subjects
        SPMS Secondary progressive multiple sclerosis
    		 14 1 2 17
        RRMS Relapsing remitting multiple sclerosis
    		 0 0 11 11
        Active SPMS-acute exacerbation or progression
    		 3 3 0 6
        MS Multiple sclerosis, not specified
    		 0 0 6 6
        Active RRMS-acute exacerbation or progression
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Siponimod - continuous
    Reporting group description
    		 Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination

    Reporting group title
    Siponimod- interrupted
    Reporting group description
    		 Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination

    Reporting group title
    DMT or no MS treatment
    Reporting group description
    		 Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination

    Primary: Percentage of participants achieving seroconversion one week after receiving second vaccine (EAS)

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    End point title
    		 Percentage of participants achieving seroconversion one week after receiving second vaccine (EAS) [1]
    End point description
    Participants achieving seroconversion as defined by detection of SARS-CoV-2 serum functional antibodies one week after second dose of vaccine.
    End point type
    Primary
    End point timeframe
    At 1 week after vaccination period (defined as 1 week after second dose of vaccine)
    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: No statistical analysis was done
    End point values
    		 Siponimod - continuous Siponimod- interrupted DMT or no MS treatment
    Number of subjects analysed
    17
    4
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Visit 1/Week 1 after second dose of vaccine
    52.9 (27.8 to 77.0)
    75.0 (19.4 to 99.4)
    90.0 (68.3 to 98.8)
    No statistical analyses for this end point

    Secondary: SARS-CoV-2 functional antibodies (% inhibition) by visits (SAF/EAS)

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    End point title
    		 SARS-CoV-2 functional antibodies (% inhibition) by visits (SAF/EAS)
    End point description
    Measurement of antibody-mediated blockage (i.e., presence of functional SARS-CoV-2 antibodies) was performed to quantify functional SARS-CoV-2 neutralizing antibodies and was calculated as % inhibition to the in-assay control.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 1, Month 1 and Month 6, after second dose vaccine; 1 month after booster
    End point values
    		 Siponimod - continuous Siponimod- interrupted DMT or no MS treatment
    Number of subjects analysed
    17
    4
    20
    Units: antibody titer levels (% inhibition)
    arithmetic mean (standard deviation)
        Screening n=17,4,20
    -3.8 ( 5.0 )
    -0.3 ( 11.1 )
    -2.6 ( 8.2 )
        Visit 1/Week 1 n=17,4,20
    38.1 ( 34.8 )
    64.0 ( 41.8 )
    82.6 ( 26.7 )
        Visit 2/Month 1 n=16,4,20
    40.1 ( 27.2 )
    87.5 ( 16.4 )
    86.8 ( 21.5 )
        Visit 3/Month 6 n=16,4,20
    43.2 ( 32.8 )
    68.3 ( 34.5 )
    77.3 ( 27.1 )
        1 Month after booster n=16,4,18
    62.3 ( 30.3 )
    96.5 ( 2.4 )
    96.8 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Number of patients reactive to INFg or IL-2 SARS-CoV-2 by visit SAF/EAS

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    End point title
    		 Number of patients reactive to INFg or IL-2 SARS-CoV-2 by visit SAF/EAS
    End point description
    The release of IFNg or IL-2 after stimulation with a SARS-CoV-2/PAN corona peptide-mix measured by enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells indicates the presence of SARS-CoV-2 reactive T-cells, i.e., a T-cell response.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, Month 1 and Month 6 after second dose of vaccine; 1 month after booster
    End point values
    		 Siponimod - continuous Siponimod- interrupted DMT or no MS treatment
    Number of subjects analysed
    17
    4
    20
    Units: participants
        Screening reactive n=17,4,20
    0
    0
    1
        Screening not reactive n=17,4,20
    10
    3
    19
        Screening missing value n=17,4,20
    7
    1
    0
        Visit 1/Week 1 reactive n=17,4,20
    7
    3
    12
        Visit 1/Week 1 not reactive n=17,4,20
    8
    1
    8
        Visit 1/Week 1 missing value n=17,4,20
    2
    0
    0
        Visit 2/Month 1 reactive n=16,4,20
    0
    1
    14
        Visit 2/Month 1 not reactive n=16,4,20
    16
    3
    6
        Visit 2/Month 1 missing value n=16,4,20
    0
    0
    0
        Visit 3/Month 6 reactive n=17,4,20
    4
    1
    14
        Visit 3/Month 6 not reactive n=17,4,20
    11
    3
    5
        Visit 3/Month 6 missing value n=17,4,20
    2
    0
    1
        Visit 1 Month after booster reactive n=16,4,18
    4
    2
    15
        Visit 1 Month after booster not reactive n=16,4,18
    10
    2
    3
        Visit 1 Mon after booster missing value n=16,4,18
    2
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from screening visit for a maximum of 69 weeks.
    Adverse event reporting additional description
    The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Siponimod continuous
    Reporting group description
    		 Siponimod continuous

    Reporting group title
    DMT or No MS Treatment
    Reporting group description
    		 DMT or No MS Treatment

    Reporting group title
    Siponimod Interrupted
    Reporting group description
    		 Siponimod Interrupted

    Serious adverse events
    		 Siponimod continuous DMT or No MS Treatment Siponimod Interrupted
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (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
    		 Siponimod continuous DMT or No MS Treatment Siponimod Interrupted
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 17 (58.82%)
    14 / 20 (70.00%)
    3 / 4 (75.00%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    Blood glucose decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    0
    1
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Flushing
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 20 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    2
    0
    Multiple sclerosis relapse
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    3 / 17 (17.65%)
    2 / 20 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    2
    0
    Influenza like illness
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 20 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 20 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    2
    0
    Chills
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    0
    1
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 20 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    3
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 20 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    5
    0
    Injection site pustule
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2021
    a) prolongation of the visit window for investigational visit 1, b) classification of adverse events according to the Common Toxicity Criteria (CTC) AE grade (version 5 or higher) c) start and optional prolongation of screening period d) optional booster/refresher SARS-CoV-2 vaccinations if suggested by local regulations e) more detailed description of IMP documentation
    25 Sep 2021
    a) termination of recruitment, b) optional treatment interruption according to SmPC also in cohort 1 in case of a booster vaccination c) an additional study visit in case of a SARS-CoV-2 booster vaccination

    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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