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    Clinical Trial Results:
    An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

    Summary
    EudraCT number
    		 2018-001059-12
    Trial protocol
    		 GB   NL  
    Global end of trial date
    27 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2025
    First version publication date
    12 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    15-HMedIdeS-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03943589
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hansa Biopharma AB
    Sponsor organisation address
    Scheelevägen 22, Lund, Sweden, 223 63
    Public contact
    Clinical Operation Department, Hansa Biopharma AB, 46 46165670, info@hansabiopharma.com
    Scientific contact
    Clinical Operation Department, Hansa Biopharma AB, 46 46165670, info@hansabiopharma.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
    03 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects
    Protection of trial subjects
    Details of the goals of the research and the risk and benefits of the protocol were reviewed with each potential study subject. In the event of adverse events from the study, full resources of the hospital were available to intervene as medically necessary. Physicians expert in the care of patients with GBS were responsible for the patients' care at each site. To mitigate the risk of infections all patients received prophylactic treatment with antibiotics administered orally once daily for 14 days starting before imlifidase infusion on Day 1. In order to reduce the risk of infusion reaction, a phenomenon that may occur with infusion of proteins, premedication with methylprednisolone (IV) and antihistamine (oral) were given to all patients before the imlifidase infusion. As participation in the trial delayed the commencement of standard IVIg treatment, a patient could, if the GBS symptoms worsened very quickly during the first 24 hours after imlifidase administration, be given PLEX to manage the rapid progression of GBS and to remove any remaining imlifidase before initiating IVIg treatment according to standard of care. This decision was made at the discretion of the investigator.
    Background therapy
    		 Standard of care IVIg infusions for 5 consecutive days at 0.4 g/kg, starting on Day 3. IVIg was given at least 48 hours after imlifidase administration and within 14 days of onset of weakness. Premedication before first dose of IVIg was given according to local clinical standard.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 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
    Netherlands: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 26
    Worldwide total number of subjects
    30
    EEA total number of subjects
    27
    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)
    18
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between 12-NOV-2019 and 02-MAR-2023.

    Pre-assignment
    Screening details
    		 A total of 31 patients were screened. Thirty (30) patients were enrolled and dosed with imlifidase.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 All patients intended to be treated
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imlifidase
    Investigational medicinal product code
    Other name
    IdeS, IgG endopeptidase
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 0.25 mg/kg was administered as an IV infusion over 30 minutes.

    Number of subjects in period 1
    		All patients intended to be treated
    Started
    30
    Completed
    28
    Not completed
    2
         Adverse event, serious fatal
    1
         Diagnosed with encephalomyelitis
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.6 ( 18.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. Used for presentation of efficacy endpoints.

    Subject analysis set title
    PK/PD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All dosed patients, with at least one PK or PD data point available post-baseline. Used for presentation of PK and PD endpoints.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All dosed patients. Used for presentation of safety endpoints

    Subject analysis sets values
    		 FAS PK/PD Safety analysis set
    Number of subjects
    27
    30
    30
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    17
    18
    18
        From 65-84 years
    10
    12
    12
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.8 ( 19.3 )
    55.6 ( 18.5 )
    55.6 ( 18.5 )
    Gender categorical
    Units: Subjects
        Female
    13
    14
    14
        Male
    14
    16
    16

    End points

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    End points reporting groups
    Reporting group title
    All patients intended to be treated
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. Used for presentation of efficacy endpoints.

    Subject analysis set title
    PK/PD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All dosed patients, with at least one PK or PD data point available post-baseline. Used for presentation of PK and PD endpoints.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All dosed patients. Used for presentation of safety endpoints

    Primary: GBS disability score - Able to walk independently

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    End point title
    		 GBS disability score - Able to walk independently [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Day 360
    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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    Units: Patients
        Baseline
    0
        Day 2
    4
        Day 3
    5
        Day 4
    9
        Day 5
    9
        Day 6
    9
        Day 7
    10
        Day 8
    10
        Day 15
    13
        Day 29
    14
        Day 57
    18
        Day 92
    20
        Day 180
    23
        Day 360
    24
    No statistical analyses for this end point

    Primary: GBS disability score - Able to run

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    End point title
    		 GBS disability score - Able to run [2]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Day 360
    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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27
    Units: Patients
        Baseline
    0
        Day 2
    0
        Day 3
    0
        Day 4
    0
        Day 5
    1
        Day 6
    1
        Day 7
    2
        Day 8
    4
        Day 15
    5
        Day 29
    9
        Day 57
    11
        Day 92
    15
        Day 180
    17
        Day 360
    18
    No statistical analyses for this end point

    Primary: GBS DS - Time to improve by at least 1 grade

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    End point title
    		 GBS DS - Time to improve by at least 1 grade [3]
    End point description
    The GBS disability score is a scoring system used to assess the status of the patients with GBS. The score consists of the following grades: 0=Healthy, 1= Minor symptoms and capable of running, 2=Able to walk independently 10 meters of more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Beridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
    End point type
    Primary
    End point timeframe
    From Baseline to Day 360
    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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27
    Units: Days
    median (full range (min-max))
        Time to improve by at least 1 grade
    6.0 (3.0 to 16.0)
    No statistical analyses for this end point

    Primary: MRC sum score over time

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    End point title
    		 MRC sum score over time [4]
    End point description
    The Medical Research Council (MRC) scale is a commonly used tool for assessing muscle strength. The resulting MRC sum score ranges from 60 (normal) to 0 (quadriplegic).
    End point type
    Primary
    End point timeframe
    From Baseline to Day 180
    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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    39.1 ( 13.9 )
        Day 2
    42.0 ( 14.7 )
        Day 4
    47.5 ( 14.6 )
        Day 6
    49.7 ( 13.7 )
        Day 8
    50.0 ( 13.8 )
        Day 15
    51.8 ( 12.1 )
        Day 29
    49.1 ( 17.4 )
        Day 57
    49.0 ( 18.4 )
        Day 92
    51.8 ( 16.2 )
        Day 180
    54.1 ( 12.4 )
    No statistical analyses for this end point

    Primary: Change in MRC sum sore over time

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    End point title
    		 Change in MRC sum sore over time [5]
    End point description
    The Medical Research Council (MRC) scale is a commonly used tool for assessing muscle strength. The resulting MRC sum score ranges from 60 (normal) to 0 (quadriplegic).
    End point type
    Primary
    End point timeframe
    Change from Baseline to Different visits up to Day 180
    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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27 [6]
    Units: Score
    arithmetic mean (standard deviation)
        Day 2
    2.9 ( 8.2 )
        Day 4
    8.4 ( 9.2 )
        Day 6
    10.3 ( 9.8 )
        Day 8
    10.7 ( 10.2 )
        Day 15
    11.2 ( 10.4 )
        Day 29
    10.0 ( 13.0 )
        Day 57
    9.9 ( 14.6 )
        Day 92
    12.7 ( 13.0 )
        Day 180
    15.0 ( 10.6 )
    Notes
    [6] - 26 patients analysed at Day 6 and Day 8 25 patients analysed at Day 15
    No statistical analyses for this end point

    Primary: R-ODS over time

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    End point title
    		 R-ODS over time [7]
    End point description
    The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. The resulting R-ODS ranges from 0 (most severe disability) to 100 (no disability at all).
    End point type
    Primary
    End point timeframe
    Baseline to Day 360
    Notes
    [7] - 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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27 [8]
    Units: R-ODS
    arithmetic mean (standard deviation)
        Baseline
    23.7 ( 15.3 )
        Day 8
    41.9 ( 28.0 )
        Day 15
    46.2 ( 26.9 )
        Day 29
    52.6 ( 33.1 )
        Day 57
    57.2 ( 34.5 )
        Day 92
    63.5 ( 32.5 )
        Day 180
    70.0 ( 29.2 )
        Day 360
    73.8 ( 24.4 )
    Notes
    [8] - 26 patients analysed at Day 8, Day 57, Day 92, and Day 360 24 patients analysed at Day 15
    No statistical analyses for this end point

    Primary: Change in R-ODS over time

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    End point title
    		 Change in R-ODS over time [9]
    End point description
    The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. The resulting R-ODS ranges from 0 (most severe disability) to 100 (no disability at all). This endpoint presents the change from baseline. A positive value indicates improvement.
    End point type
    Primary
    End point timeframe
    From Baseline to Day 360
    Notes
    [9] - 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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27 [10]
    Units: R-ODS
    arithmetic mean (standard deviation)
        Day 8
    17.2 ( 22.3 )
        Day 15
    20.8 ( 21.4 )
        Day 29
    28.8 ( 25.3 )
        Day 57
    34.5 ( 26.5 )
        Day 92
    40.8 ( 24.6 )
        Day 180
    46.3 ( 22.7 )
        Day 360
    50.5 ( 19.3 )
    Notes
    [10] - 26 patients analysed at Day 8, Day 57, Day 92, and Day 360 24 patients analysed at Day 15
    No statistical analyses for this end point

    Primary: Days in Hospital

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    End point title
    		 Days in Hospital [11]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Day 360
    Notes
    [11] - 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: Not applicable, this was a single arm study.
    End point values
    		 Safety analysis set
    Number of subjects analysed
    30
    Units: Days
        arithmetic mean (standard deviation)
    32.5 ( 43.5 )
    No statistical analyses for this end point

    Primary: Time in an ICU

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    End point title
    		 Time in an ICU [12]
    End point description
    End point type
    Primary
    End point timeframe
    From Screening to Day 180
    Notes
    [12] - 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: Not applicable, this was a single arm study.
    End point values
    		 Safety analysis set
    Number of subjects analysed
    30
    Units: Patients
        Admitted 0 days
    18
        Admitted 2-11 days
    9
        Admitted 106-113 days
    2
        Admitted 172 days
    1
    No statistical analyses for this end point

    Primary: Need for mechanical ventilation

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    End point title
    		 Need for mechanical ventilation [13]
    End point description
    End point type
    Primary
    End point timeframe
    Screening to Day 180
    Notes
    [13] - 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: Not applicable, this was a single arm study.
    End point values
    		 Safety analysis set
    Number of subjects analysed
    30
    Units: Patients
        Screening
    0
        Day 1 to Day 90
    1
        Day 5 to Day 102
    1
        Day 9 to Day 90 and Day 103 to Day 180
    1
    No statistical analyses for this end point

    Primary: Quality of Life over time

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    End point title
    		 Quality of Life over time [14]
    End point description
    The EQ-5D-5L questionnaire was completed by the patients. It consists of descriptive statements pertaining to 5 individual dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). The patient was asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale where the endpoints are labelled ‘The best health you can image’ and ‘The worst health you can image’.
    End point type
    Primary
    End point timeframe
    From Day 8 to Day 360
    Notes
    [14] - 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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    30 [15]
    Units: EQ-5D-5L VAS score
    arithmetic mean (standard deviation)
        Day 8
    49.7 ( 23.7 )
        Day 15
    61.3 ( 24.8 )
        Day 29
    67.3 ( 21.0 )
        Day 57
    68.8 ( 25.1 )
        Day 92
    75.2 ( 23.9 )
        Day 180
    78.6 ( 20.6 )
        Day 360
    79.4 ( 18.6 )
    Notes
    [15] - 27 replied at D92 and D180 26 replied at D8 and D360 25 replied at D29 and D57 24 replied at D15
    No statistical analyses for this end point

    Primary: GBS DS - Time to improve by at least 2 grades

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    End point title
    		 GBS DS - Time to improve by at least 2 grades [16]
    End point description
    The GBS disability score is a scoring system used to assess the status of the patients with GBS. The score consists of the following grades: 0=Healthy, 1= Minor symptoms and capable of running, 2=Able to walk independently 10 meters of more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Beridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
    End point type
    Primary
    End point timeframe
    Baseline to Day 360
    Notes
    [16] - 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: Not applicable, this was a single arm study.
    End point values
    		 FAS
    Number of subjects analysed
    27
    Units: Days
    median (full range (min-max))
        Time to improve by at least 2 grades
    16.0 (8.0 to 92.0)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) - Cmax, AUC, t1/2 (alfa), t1/2 (beta), CL, Vss, and Vz

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    End point title
    		 Pharmacokinetics (PK) - Cmax, AUC, t1/2 (alfa), t1/2 (beta), CL, Vss, and Vz
    End point description
    Cmax=Maximum observed plasma concentration of imlifidase following dosing AUC=Area under the plasma concentration of imlifidase versus time curve t½α=Half-life initial phase t½β=Half-life terminal phase CL=Clearance is a measure of the ability of the body to clear imlifidase from plasma Vz=Volume of distribution of imlifidase during the elimination phase Vss=Volume of distribution at steady state
    End point type
    Secondary
    End point timeframe
    From dosing until Day 15
    End point values
    		 PK/PD
    Number of subjects analysed
    16 [17]
    Units: See below:
    geometric mean (geometric coefficient of variation)
        Cmax (µg/mL)
    5.5 ( 17.0 )
        AUC (h×µg/mL)
    45.0 ( 54.9 )
        t½ (h) initial phase (α)
    1.73 ( 0 )
        t½ (h) terminal phase (β)
    30.6 ( 0 )
        CL (mL/h/kg)
    5.6 ( 54.9 )
        Vz (L/kg)
    0.3 ( 40.7 )
        Vss (L/kg)
    0.2 ( 41.1 )
    Notes
    [17] - Cmax for all 16. All other for 9 who could be fitted to 2-compart model. Harmonic mean for t1/2s.
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - IgG level in serum over time

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    End point title
    		 Pharmacodynamics - IgG level in serum over time
    End point description
    The pharmacodynamic (PD)effect of imlifidase is assessed as the elimination of IgG. IgG is cleaved by imlifidase in two steps, the first cut generates single-cleaved IgG (scIgG), and the second cut generates one F(ab’)2 fragment and one Fc fragment. The IgG concentration measured in serum using the MSD technology is the sum of intact IgG and scIgG and a decrease in the measured IgG concentration therefore represents complete cleavage of the IgG molecule to Fc and F(ab’)2 fragments. For the first 16 patients included in the trial a more frequent PD sampling schedule was conducted. After amending the protocol a less frequent PD sampling schedule was applied.
    End point type
    Secondary
    End point timeframe
    Day 1 (before dose) until Day 15
    End point values
    		 PK/PD
    Number of subjects analysed
    30 [18]
    Units: mg/mL
    arithmetic mean (standard deviation)
        Day 1, pre-dose
    10.8 ( 4.5 )
        Day 2, 24 hours after dose
    1.3 ( 3.5 )
        Day 3, before IVIg administration
    1.6 ( 3.5 )
        Day 4, before IVIg administration
    8.6 ( 2.3 )
        Day 5, before IVIg administration
    14.3 ( 1.9 )
        Day 6, before IVIg administration
    18.1 ( 4.0 )
        Day 7, before IVIg administration
    20.8 ( 5.5 )
        Day 8
    28.6 ( 9.2 )
        Day 15
    22.5 ( 10.0 )
    Notes
    [18] - 16 patients analysed at Day 4, Day 5, Day 6, and Day 7 as described above.
    No statistical analyses for this end point

    Secondary: Immunogenicity - Anti-imlifidase antibodies (ADA) over time

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    End point title
    		 Immunogenicity - Anti-imlifidase antibodies (ADA) over time
    End point description
    Anti-imlifidase IgG antibodies (ADA) in serum.
    End point type
    Secondary
    End point timeframe
    Predose until Day 180
    End point values
    		 Safety analysis set
    Number of subjects analysed
    30 [19]
    Units: mg/mL
    arithmetic mean (standard deviation)
        Day 1, pre-dose
    11.1 ( 17.1 )
        Day 2, 24 h after dose
    4.0 ( 9.6 )
        Day 3, pre-IVIg
    4.5 ( 12.2 )
        Day 8
    474.5 ( 909.0 )
        Day 15
    2811.9 ( 3772.6 )
        Day 29
    2120.1 ( 2813.7 )
        Day 57
    1060.3 ( 1086.5 )
        Day 92
    722.1 ( 806.8 )
        Day 180
    336.0 ( 318.9 )
    Notes
    [19] - 28 patients have been analysed at Day 29, Day 57, Day 92, and Day 180
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) - Tmax

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    End point title
    		 Pharmacokinetics (PK) - Tmax
    End point description
    Tmax = Time point for maximum observed plasma concentration of imlifidase following dosing
    End point type
    Secondary
    End point timeframe
    From dosing until Day 15
    End point values
    		 PK/PD
    Number of subjects analysed
    16
    Units: hours
    median (full range (min-max))
        Tmax (h)
    0.74 (0.47 to 2.07)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
    Adverse event reporting additional description
    AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A TEAE is any AE occurring after imlifidase and within 29 days. The listed non-serious AEs presents TEAEs only. 18 SAEs have been reported, 9 of which were TEAEs. All SAEs are listed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 All 30 patients who have received imlifidase in the trial. 25 out of 30 patients were affected by non-serious treatment emergent adverse events (TEAEs). 28 out of 30 patients were affected by non-serious AEs, including pre-treatment and post-treatment emergent events. 5 out of 30 patients were affected by treatment emergent SAEs. 7 out of 30 patients were affected by SAEs including pre-treatment and post-treatment emergent events.

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 30 (23.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Investigations
    False positive investigation result
    Additional description: Covid false positive
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Central nervous system inflammation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Demyelination
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3.3%
    Non-serious adverse events
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 30 (83.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 30 (20.00%)
         occurrences all number
    6
    Deep vein thrombosis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Chills
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vessel puncture site phlebitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pneumonia aspiration
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pulmonary mass
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Rales
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Stridor
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 30 (20.00%)
         occurrences all number
    6
    Insomnia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Delirium
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hallucination
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hallucination, visual
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    C-reactive protein increased
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Liver function test abnormal
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    White blood cell count increased
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Body temperature increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Staphylococcus test positive
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Troponin I increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Facial paralysis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vocal cord paresis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Normocytic anaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    9 / 30 (30.00%)
         occurrences all number
    9
    Abdominal pain upper
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cheilitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Cholestasis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Prerenal failure
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Spinal pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Corona virus infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Erysipelas
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Hypokalaemia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Folate deficiency
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gout
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vitamin B1 deficiency
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2019
    - Updates to the SRC composition - Modification of 2 eligibility criteria - More detailed guidance about IVIg treatment
    09 Oct 2020
    Patients with a positive PCR test for SARS-CoV-2 (Covid-19) should be excluded from the trial before restarting the trial. In addition, patients with an ongoing infection were to be excluded from the trial regardless if the infection required treatment or not.
    11 Jun 2021
    - Minor modifications to the screening procedures were introduced (SARS-CoV-2 PCR test results if done at hospital admission could be used), thus minimising the risk of unnecessary delay of GBS treatment.
    31 Jan 2022
    - PK sampling and ECG data collection were removed from the protocol as available data were deemed sufficient. - A less frequent sampling schedule was introduced - Addition of safety sections describing overdose and adverse events of special interest (AESIs). - Change in CRO responsible for SAE/suspected unexpected serious adverse reaction (SUSAR) reporting. - Prohibited therapies updated and clarified.
    27 Jun 2023
    - To avoid delay in the reporting of the results of the single arm trial, the planned comparison to an externally matched cohort of GBS subjects will be outlined in a separate study protocol - To ensure comparison of relevant endpoints in the non-interventional study (matched cohort of GBS subjects) some endpoints were updated or added to the trial protocol. The objective, endpoints, and statistical sections were updated to reflect these changes. - To ensure the trial results can be properly evaluated and clinically interpreted, additional baseline and disease characteristic data were added to the protocol. These data were to be collected from the patient’s medical records.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Mar 2020
    This trial started in November 2019 and was completed in February 2024, which included the period during which the Covid-19 pandemic was ongoing in the countries with participating trial sites. In March 2020 the SRC recommended Hansa Biopharma to temporarily halt the enrolment of new patients into the trial due to the pandemic. The already included patients in the trial at the timepoint for halt of enrolment continued in the trial according to protocol. In September 2020, an ad-hoc SRC meeting was held to discuss restart of enrolment into the trial. The SRC members agreed that recruitment of patients in the trial could restart on a site-by-site basis after discussion with and confirmation by each principal investigator after amending the protocol to exclude patients with a positive PCR test for SARS-CoV-2 (Covid-19).
    30 Sep 2020

    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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