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    Clinical Trial Results:
    A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

    Summary
    EudraCT number
    		 2016-002938-73
    Trial protocol
    		 BE   SE   ES   NL   IT  
    Global end of trial date
    20 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2018
    First version publication date
    03 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARGX-113-1602
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02965573
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    argenx
    Sponsor organisation address
    Industriepark 7, Zwijnaarde, Belgium, 9052
    Public contact
    Regulatory, argenx BVBA, +32 9310 3400, regulatory@argenx.com
    Scientific contact
    Regulatory, argenx BVBA, +32 9310 3400, regulatory@argenx.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
    20 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of ARGX 113.
    Protection of trial subjects
    Safety assessments consisted of monitoring and recording all AEs, including SAEs, and pregnancies; suicidality assessment; safety laboratory testing, measurement of vital signs, ECGs, physical examinations; and other tests that were deemed critical to the safety evaluation of the study in all subjects who received at least 1 dose of the IMP.
    Background therapy
    		 In this study, standard of care (SoC) for a patient was the stable dose and administration of their MG treatment prior to enrollment. Permitted SoC for MG treatment under this protocol included azathioprine (AZA), other non steroidal immunosuppressant drugs (NSIDs: e.g., methotrexate, cyclosporine, tacrolimus, mycophenolate mofetil, and cyclophosphamide), steroids, as well as cholinesterase inhibitors. Patients had to be on a stable dose and frequency of SoC prior to enrollment as detailed in the protocol and for the duration of the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2016
    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
    Canada: 1
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Italy: 4
    Worldwide total number of subjects
    24
    EEA total number of subjects
    19
    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
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted by 15 Investigators at 15 study centers (i.e., study centers that consented at least 1 patient) in 8 countries (Belgium, Canada, Italy, the Netherlands, Poland, Spain, Sweden, and United States). A total of 24 subjects were randomized in the study.

    Pre-assignment
    Screening details
    		 The study included a maximum Screening period of 15 days to evaluate patients’ eligibility. Evaluations at screening and confirmation at visit 1 were used to determine the eligibility of each subject for randomization in the study. Subjects who failed to meet the eligibility criteria were considered screen failures.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The IMPs (ARGX-113 and placebo) were identical in physical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARGX-113
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    efgartigimod
    Investigational medicinal product code
    ARGX-113
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ARGX-113 was administered weekly for 4 weeks by intravenous infusion.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered weekly for 4 weeks by intravenous use.

    Number of subjects in period 1
    		ARGX-113 Placebo
    Started
    12
    12
    Completed
    11
    12
    Not completed
    1
    0
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARGX-113
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 ARGX-113 Placebo Total
    Number of subjects
    		 12 12 24
    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)
    		 8 10 18
        From 65-84 years
    		 4 2 6
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 8 15
        Male
    		 5 4 9

    End points

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    End points reporting groups
    Reporting group title
    ARGX-113
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: 1. Adverse events

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    End point title
    		 1. Adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    The entire duration of the study.
    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: The primary endpoint is analysed by means of descriptive statistics.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Number of events/ Number of patients
        Number of events
    60
    44
        Patients with at least 1 TEAE
    10
    10
        Patients with at least 1 nonTEAE
    2
    4
        Patients with at least 1 serious TEAE
    0
    0
        Patients withdrawn with at least 1 serious TEAE
    0
    0
        Patients with at least 1 related serious TEAE
    0
    0
        Patients who discontinued due to a TEAE
    0
    0
        Patients with at least 1 TEAE CTCAE >=3
    0
    0
        Patients with at least 1 related TEAE
    8
    3
        Number of deaths
    0
    0
    No statistical analyses for this end point

    Secondary: 2. MG-ADL Score Change from Baseline

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    End point title
    		 2. MG-ADL Score Change from Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Score change
    median (full range (min-max))
        Day 1 (Baseline)
    7.5 (5 to 15)
    8.0 (5 to 13)
        Day 8
    -1.0 (-10 to 0)
    -0.5 (-4 to 2)
        Day 15
    -2.0 (-9 to 0)
    -2.0 (-7 to 0)
        Day 22
    -3.5 (-8 to 0)
    -2.0 (-7 to 1)
        Day 29
    -4.0 (-8 to 0)
    -1.0 (-7 to 0)
        Day 36
    -3.5 (-10 to 1)
    -1.5 (-6 to 1)
        Day 43
    -4.0 (-8 to 1)
    -1.0 (-8 to 1)
        Day 50
    -3 (-11 to -1)
    -1.0 (-9 to 0)
        Day 64
    -2.5 (-9 to 1)
    -1.0 (-8 to 5)
        Day 78
    -3.0 (-10 to 1)
    -1.0 (-9 to 4)
    No statistical analyses for this end point

    Secondary: 3. QMG score change from baseline

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    End point title
    		 3. QMG score change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Score change from baseline
    median (full range (min-max))
        Day 1 (Baseline)
    14.0 (6 to 30)
    12.5 (3 to 24)
        Day 8
    -2.0 (-10 to 0)
    0 (-3 to 4)
        Day 15
    -3.0 (-12 to 1)
    -1.5 (-8 to 2)
        Day 22
    -3.0 (-14 to 3)
    -2.0 (-8 to 4)
        Day 29
    -4.5 (-16 to 1)
    -1.0 (-8 to 4)
        Day 36
    -3.5 (-16 to 2)
    -0.5 (-10 to 1)
        Day 43
    -3.5 (-15 to 3)
    -2.0 (-10 to 6)
        Day 50
    -5.0 (-16 to 2)
    -1.0 (-10 to 3)
        Day 64
    -2.0 (-15 to 2)
    -1.0 (-13 to 3)
        Day 78
    -2.0 (-18 to 3)
    -1.5 (-11 to 4)
    No statistical analyses for this end point

    Secondary: 4. MGC score change from baseline

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    End point title
    		 4. MGC score change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Score change from baseline
    median (full range (min-max))
        Day 1 (baseline)
    14.0 (6 to 37)
    14.0 (8 to 25)
        Day 8
    -4.0 (-17 to 4)
    -0.5 (-6 to 3)
        Day 15
    -5.5 (-16 to 4)
    -3.5 (-14 to 1)
        Day 22
    -5.5 (-19 to 2)
    -3.5 (-11 to 0)
        Day 29
    -8.0 (-19 to 5)
    -4.0 (-12 to 4)
        Day 36
    -7.5 (-21 to 7)
    -4.0 (-12 to 4)
        Day 43
    -10.5 (-20 to 7)
    -5.0 (-12 to 8)
        Day 50
    -5.0 (-23 to 1)
    -2.5 (-13 to 4)
        Day 64
    -6.0 (-21 to 4)
    -3.0 (-15 to 7)
        Day 78
    -8.0 (-23 to 6)
    -3.5 (-14 to 5)
    No statistical analyses for this end point

    Secondary: 5. MGQoL15r score change from baseline

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    End point title
    		 5. MGQoL15r score change from baseline
    End point description
    Myasthenia Gravis Quality of Life-15 (revised version)
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Score change from baseline
    median (full range (min-max))
        Day 1 (Baseline)
    21.0 (10 to 28)
    12.5 (5 to 25)
        Day 8
    0 (-20 to 2)
    0 (-5 to 2)
        Day 15
    -2.5 (-16 to 0)
    0 (-6 to 3)
        Day 22
    -3.0 (-17 to 0)
    0 (-8 to 2)
        Day 29
    -3.0 (-18 to 2)
    0 (-8 to 2)
        Day 36
    -6.0 (-19 to 2)
    -1.0 (-11 to 3)
        Day 43
    -4.5 (-19 to 2)
    0 (-10 to 3)
        Day 50
    -4.0 (-12 to 2)
    -1.0 (-10 to 3)
        Day 64
    -3.0 (-15 to 2)
    0 (-10 to 3)
        Day 78
    -3.0 (-15 to 5)
    -0.5 (-10 to 3)
    No statistical analyses for this end point

    Secondary: 6. Maximum reduction from Baseline across visit days for the various scores

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    End point title
    		 6. Maximum reduction from Baseline across visit days for the various scores
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Maximum reduction
    median (full range (min-max))
        Myasthenia Gravis Activities of Daily Living
    -4.5 (-11 to 0)
    -2.0 (-9 to 0)
        Quantitative Myasthenia Gravis
    -4.5 (-18 to -2)
    -4.0 (-13 to 1)
        Myasthenia Gravis Composite
    -10.5 (-23 to -1)
    -6.5 (-15 to -2)
        Myasthenia Gravis Quality of Life-15 (revised v.)
    -6.0 (-20 to -1)
    -3.0 (-11 to 0)
    No statistical analyses for this end point

    Secondary: 7. Pharmacokinetics: Cmax

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    End point title
    		 7. Pharmacokinetics: Cmax
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 22.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12 [2]
    0 [3]
    Units: µg/mL
    median (full range (min-max))
        Day 1
    173.5 (114 to 276)
    ( to )
        Day 8
    173.0 (117 to 219)
    ( to )
        Day 15
    156.0 (110 to 209)
    ( to )
        Day 22
    156.0 (113 to 253)
    ( to )
    Notes
    [2] - As of Day 8, values for n=11
    [3] - No pharmacokinetic analysis was performed for placebo-treated subjects.
    No statistical analyses for this end point

    Secondary: 8. Pharmacokinetics: Tmax

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    End point title
    		 8. Pharmacokinetics: Tmax
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 22.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    0 [4]
    Units: Hours
    median (full range (min-max))
        Day 1
    2.44 (2.08 to 2.58)
    ( to )
        Day 8
    2.50 (2.08 to 2.50)
    ( to )
        Day 15
    2.50 (2.07 to 2.50)
    ( to )
        Day 22
    2.46 (2.08 to 2.67)
    ( to )
    Notes
    [4] - No pharmacokinetic analysis was performed for placebo-treated subjects.
    No statistical analyses for this end point

    Secondary: 9. Evaluation of total IgG

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    End point title
    		 9. Evaluation of total IgG
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Baseline) until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: µg/mL
    median (full range (min-max))
        Day 1 (Baseline)
    8825 (4340 to 19800)
    6855 (4670 to 14700)
        Day 8
    5400 (2610 to 13800)
    7220 (4050 to 13900)
        Day 15
    3825 (1620 to 9120)
    7840 (4480 to 14300)
        Day 22
    2475 (1680 to 4790)
    6800 (4800 to 12900)
        Day 29
    2540 (1370 to 7600)
    6460 (4330 to 13200)
        Day 36
    4590 (1410 to 8430)
    6745 (5180 to 9940)
        Day 43
    3870 (2240 to 12300)
    7210 (3880 to 10600)
        Day 50
    5310 (2410 to 14300)
    7435 (4530 to 11100)
        Day 57
    6070 (3080 to 16400)
    7610 (4890 to 13300)
        Day 64
    6220 (3940 to 13100)
    7225 (4480 to 14400)
        Day 71
    6080 (2750 to 21700)
    7585 (4180 to 14700)
        Day 78
    7095 (1890 to 24200)
    7420 (5000 to 14200)
    No statistical analyses for this end point

    Secondary: 10. Evaluation of anti-AChR antibodies

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    End point title
    		 10. Evaluation of anti-AChR antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: nmol/L
    median (full range (min-max))
        Day 1
    7.030 (0.265 to 106.000)
    11.115 (0.398 to 186.000)
        Day 8
    5.035 (0.265 to 51.700)
    10.715 (0.401 to 223.000)
        Day 15
    4.185 (0.265 to 38.100)
    11.845 (0.379 to 179.000)
        Day 22
    2.160 (0.265 to 34.900)
    11.545 (0.366 to 169.000)
        Day 29
    3.755 (0.265 to 32.100)
    6.185 (0.265 to 173.000)
        Day 36
    4.280 (0.265 to 40.100)
    12.200 (0.380 to 188.000)
        Day 43
    5.590 (0.265 to 46.300)
    3.310 (0.361 to 168.000)
        Day 50
    5.390 (0.265 to 52.400)
    6.805 (0.379 to 162.000)
        Day 57
    6.330 (0.265 to 73.600)
    7.390 (0.370 to 213.000)
        Day 64
    6.470 (0.265 to 73.700)
    7.375 (0.366 to 169.000)
        Day 71
    7.790 (0.265 to 73.100)
    13.050 (0.367 to 181.000)
        Day 78
    7.165 (0.265 to 88.900)
    7.425 (0.356 to 165.000)
    No statistical analyses for this end point

    Secondary: 11. Evaluation of the incidence of anti-drug antibodies

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    End point title
    		 11. Evaluation of the incidence of anti-drug antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 78.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Subjects
        Subjects with pre-dose ADA titers
    4
    2
        Subjects with post-dose ADA titers
    4
    3
    No statistical analyses for this end point

    Post-hoc: 12. Percentage of patients with sustained clinically relevant improvement (drop in MG-ADL score ≥ 2)

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    End point title
    		 12. Percentage of patients with sustained clinically relevant improvement (drop in MG-ADL score ≥ 2)
    End point description
    Sustained clinically relevant improvement is defined in this case as starting the latest 1 week after last infusion of IMP and lasting for ≥ 4 consecutive weeks.
    End point type
    Post-hoc
    End point timeframe
    For the duration of the study
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
        number (not applicable)
    75.0
    33.3
    No statistical analyses for this end point

    Post-hoc: 13. Percentage of patients with sustained clinically relevant improvement (drop in MG-ADL ≥ 2)

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    End point title
    		 13. Percentage of patients with sustained clinically relevant improvement (drop in MG-ADL ≥ 2)
    End point description
    Sustained clinically relevant improvement is defined as starting at the latest 1 week after last infusion of IMP and lasting for ≥ 6 weeks.
    End point type
    Post-hoc
    End point timeframe
    For the duration of the study.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
        number (not applicable)
    75
    25
    No statistical analyses for this end point

    Post-hoc: 14. Percentage of patients showing at least x points reduction in total MG-ADL score at Day 29

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    End point title
    		 14. Percentage of patients showing at least x points reduction in total MG-ADL score at Day 29
    End point description
    End point type
    Post-hoc
    End point timeframe
    At Day 29
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
    number (not applicable)
        Change from baseline: -2
    83
    42
        Change from baseline: -3
    75
    33
        Change from baseline: -4
    58
    33
        Change from baseline: -5
    42
    25
        Change from baseline: -6
    25
    17
        Change from baseline: -7
    25
    8
        Change from baseline: -8
    17
    0
        Change from baseline: -9
    0
    0
        Change from baseline: -10
    0
    0
    No statistical analyses for this end point

    Post-hoc: 15. Percentage of patients showing at least x points reduction in total MG-ADL score at Day 36

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    End point title
    		 15. Percentage of patients showing at least x points reduction in total MG-ADL score at Day 36
    End point description
    End point type
    Post-hoc
    End point timeframe
    Day 36
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
    number (not applicable)
        Change from baseline: -2
    75
    50
        Change from baseline: -3
    67
    33
        Change from baseline: -4
    50
    25
        Change from baseline: -5
    42
    25
        Change from baseline: -6
    33
    17
        Change from baseline: -7
    33
    0
        Change from baseline: -8
    17
    0
        Change from baseline: -9
    8
    0
        Change from baseline: -10
    8
    0
    No statistical analyses for this end point

    Post-hoc: 16. Percentage of patients with sustained clinically relevant improvement (drop in QMG score ≥ 3)

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    End point title
    		 16. Percentage of patients with sustained clinically relevant improvement (drop in QMG score ≥ 3)
    End point description
    Sustained response is defined as starting at the latest 1 week after last infusion of IMP and lasting for ≥ 4 consecutive weeks.
    End point type
    Post-hoc
    End point timeframe
    For the duration of the study.
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
        number (not applicable)
    58.3
    16.7
    No statistical analyses for this end point

    Post-hoc: 17. Percentage of patients showing at least x points reduction in total QMG score at Day 29

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    End point title
    		 17. Percentage of patients showing at least x points reduction in total QMG score at Day 29
    End point description
    End point type
    Post-hoc
    End point timeframe
    Day 29
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    11 [5]
    Units: Percentage
    number (not applicable)
        Change from baseline: -3
    58
    27
        Change from baseline: -4
    58
    27
        Change from baseline: -5
    50
    18
        Change from baseline: -6
    42
    18
        Change from baseline: -7
    25
    18
        Change from baseline: -8
    25
    9
        Change from baseline: -9
    25
    0
        Change from baseline: -10
    17
    0
        Change from baseline: -11
    8
    0
        Change from baseline: -12
    8
    0
    Notes
    [5] - missing value in 1 patient
    No statistical analyses for this end point

    Post-hoc: 18. Percentage of patients showing at least x points reduction in total QMG score at Day 36

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    End point title
    		 18. Percentage of patients showing at least x points reduction in total QMG score at Day 36
    End point description
    End point type
    Post-hoc
    End point timeframe
    Day 36
    End point values
    		 ARGX-113 Placebo
    Number of subjects analysed
    12
    12
    Units: Percentage
    number (not applicable)
        Change from baseline: -3
    58
    33
        Change from baseline: -4
    50
    25
        Change from baseline: -5
    42
    17
        Change from baseline: -6
    33
    17
        Change from baseline: -7
    33
    8
        Change from baseline: -8
    33
    8
        Change from baseline: -9
    25
    8
        Change from baseline: -10
    25
    8
        Change from baseline: -11
    25
    0
        Change from baseline: -12
    25
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For each subject, adverse events were recorded from the time of signing the informed consent form until last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    ARGX-113
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 ARGX-113 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ARGX-113 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 12 (83.33%)
    10 / 12 (83.33%)
    Investigations
    B-lymphocyte count decreased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Monocyte count decreased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Neutrophil count increased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 12 (33.33%)
    3 / 12 (25.00%)
         occurrences all number
    9
    5
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Toothache
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Tooth abscess
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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