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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis

    Summary
    EudraCT number
    		 2018-002247-28
    Trial protocol
    		 GB   BE   PL   ES   IT  
    Global end of trial date
    25 Jun 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jun 2023
    First version publication date
    07 Jul 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MOM-M281-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03772587
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Momenta Pharmaceuticals, Inc.
    Sponsor organisation address
    301 Binney Street, Cambridge, United States, MA02142
    Public contact
    Clinical Registry group, Momenta Pharmaceuticals, Inc., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Momenta Pharmaceuticals, Inc., ClinicalTrialsEU@its.jnj.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
    25 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial was to evaluate the efficacy of nipocalimab for generalized myasthenia gravis (gMG) as measured by the change in Myasthenia Gravis – Activities of Daily Living (MG-ADL) score and to evaluate the safety and tolerability of treatment with nipocalimab in subjects with gMG who have an insufficient clinical response to ongoing, stable standard of care therapy.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice (GCP) and applicable regulatory requirements. Safety assessments included collection of adverse events (AEs) and serious AEs (SAEs), clinical laboratory testing (including chemistry, hematology, coagulation, and urinalysis), vital signs, physical examinations, electrocardiogram (ECG) findings, and the Columbia-Suicide Severity Rating Scale (C-SSRS).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2018
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    68
    EEA total number of subjects
    34
    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)
    43
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 68 subjects were randomized and treated with study drug, with 65 subjects completing the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo was administered as IV infusion once Q2W starting Day 1 up to Day 57.

    Arm title
    		 Nipocalimab (M281) 5 milligrams/kilogram (mg/kg)
    Arm description
    		 Subjects received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo was administered as IV infusion on Days 15 and 43 to maintain the blinding.

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nipocalimab 5 mg/kg was administered once Q4W as IV infusion starting Day 1 up to Day 57.

    Arm title
    		 Nipocalimab 30 mg/kg
    Arm description
    		 Subjects received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo was administered as IV infusion on Days 15 and 43 to maintain the blinding.

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nipocalimab 30 mg/kg was administered once Q4W as IV infusion starting Day 1 up to Day 57.

    Arm title
    		 Nipocalimab 60 mg/kg
    Arm description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, subjects received matching placebo on Days 15, 29, 43 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo was administered as IV infusion on Days 15, 29, 43 and 57 to maintain the blind.

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nipocalimab 60 mg/kg single dose was administered as IV infusion on Day 1.

    Arm title
    		 Nipocalimab 60 mg/kg (Q2W)
    Arm description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nipocalimab 60 mg/kg was administered once Q2W as IV infusion starting Day 1 up to Day 57.

    Number of subjects in period 1
    		Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Started
    14
    14
    13
    13
    14
    Completed
    13
    14
    12
    12
    14
    Not completed
    1
    0
    1
    1
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -
         Covid-19
    -
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.

    Reporting group title
    Nipocalimab (M281) 5 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 30 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 60 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, subjects received matching placebo on Days 15, 29, 43 and 57.

    Reporting group title
    Nipocalimab 60 mg/kg (Q2W)
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.

    Reporting group values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W) Total
    Number of subjects
    		 14 14 13 13 14 68
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 8 9 9 9 8 43
        From 65 to 84 years
    		 6 5 4 4 6 25
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.7 ( 17.85 ) 54.8 ( 17.64 ) 49 ( 19.54 ) 53.1 ( 15.4 ) 59.9 ( 15.03 ) -
    Title for Gender
    Units: subjects
        Female
    		 8 6 9 9 5 37
        Male
    		 6 8 4 4 9 31

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.

    Reporting group title
    Nipocalimab (M281) 5 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 30 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 60 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, subjects received matching placebo on Days 15, 29, 43 and 57.

    Reporting group title
    Nipocalimab 60 mg/kg (Q2W)
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.

    Primary: Number of Subjects with Treatment-emergent Adverse Events of Special Interest (AESI)

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events of Special Interest (AESI) [1]
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI. The safety population included all subjects who received any amount of nipocalimab or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 113
    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 Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: subjects
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Treatment-emergent Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects with Treatment-emergent Serious Adverse Events (SAEs) [2]
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. The safety population included all subjects who received any amount of nipocalimab or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 113
    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: No Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: subjects
    2
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Treatment-emergent Adverse Event (TEAEs) as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Event (TEAEs) as a Measure of Safety and Tolerability [3]
    End point description
    An adverse event (AE) is any untoward medical event that occurs in a subject administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. The Safety Population included all subjects who received any amount of nipocalimab or placebo.
    End point type
    Primary
    End point timeframe
    Up to Day 113
    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: No Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: subjects
    11
    12
    9
    12
    12
    No statistical analyses for this end point

    Primary: Change from Baseline to Day 57 in the Myasthenia Gravis – Activities of Daily Living (MG-ADL) Total Score

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    End point title
    		 Change from Baseline to Day 57 in the Myasthenia Gravis – Activities of Daily Living (MG-ADL) Total Score [4]
    End point description
    MG-ADL assesses the subject’s MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) on a 4-point rating scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores ranging from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. Intent-to-treat (ITT) population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline to Day 57
    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: No Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    14
    12
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    -1.8 ( 3.22 )
    -2.5 ( 2.41 )
    -3.9 ( 3.00 )
    -1.5 ( 2.82 )
    -3.9 ( 3.66 )
    No statistical analyses for this end point

    Secondary: Model Predicated Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57

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    End point title
    		 Model Predicated Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57
    End point description
    MG-ADL assesses subject’s MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) on a 4-point scale rating scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores ranging from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. Higher IgG lowering indicated higher MG-ADL score reductions. Analysis for this endpoint was performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling as planned. ITT population included all randomized subjects. Here ‘99999’ indicates that data for this endpoint was analyzed graphically based on Model prediction for evaluating relationship between MG-ADL and IgG; no descriptive statistics was performed.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    9999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Subjects Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57

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    End point title
    		 Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Subjects Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
    End point description
    MG-ADL assesses subject’s MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) on a 4-point scale rating : 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores ranging from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. Higher IgG lowering indicated higher MG-ADL score reductions. ITT population included all randomized subjects. Here '99999' indicates that 90 percent (%) of subjects were positive for Anti-AChR antibodies. In that case, data of anti-AChR positive subgroup must be same as of total population, so analyses for subgroup was not performed. Data for total population was analyzed graphically based on Model prediction for evaluating the relationship between MG-ADL and IgG; no descriptive statistics was performed.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Model Predicted Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57

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    End point title
    		 Model Predicted Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57
    End point description
    The QMG test was used to assess the subject’s strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. Subjects with higher IgG lowering tended to have higher QMG score reductions. Analysis for this endpoint was performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling as planned. ITT population included all randomized subjects. Here ‘99999’ indicates that data for this endpoint was captured graphically based on Model prediction for evaluating relationship between QMG and IgG; no descriptive statistics was performed.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Subjects Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57

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    End point title
    		 Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Subjects Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
    End point description
    The QMG test was used to assess the subject’s strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. Subjects with higher IgG lowering tended to have higher QMG score reductions. ITT population included all randomized subjects. Here '99999' indicates that 90 % of the subjects were positive for Anti-AChR antibodies. In that case, data of the anti-AChR positive subgroup must be same as of total population, so analyses for the subgroup was not performed. Data for total population was analyzed graphically based on Model prediction for evaluating the relationship between QMG and IgG; no descriptive statistics was performed.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    14
    13
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With a 2-, 3-, 4-, 5-, 6-, 7-, or greater than or equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57

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    End point title
    		 Number of Subjects With a 2-, 3-, 4-, 5-, 6-, 7-, or greater than or equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57
    End point description
    MG-ADL assesses the subject’s MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) on a 4-point scale rating scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores ranging from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. Population analyzed included ITT subjects for whom data was available at Day 57.
    End point type
    Secondary
    End point timeframe
    Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    14
    12
    13
    14
    Units: subjects
        2-point Improved
    7
    9
    10
    7
    12
        3-point Improved
    5
    9
    8
    5
    11
        4-point Improved
    1
    5
    5
    3
    7
        5-point Improved
    1
    2
    5
    2
    6
        6-point Improved
    1
    1
    3
    1
    3
        7-point Improved
    1
    1
    3
    0
    2
        >= 8-point Improved
    1
    0
    1
    0
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total QMG Score at Day 57

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    End point title
    		 Change From Baseline in Total QMG Score at Day 57
    End point description
    The QMG test was used to assess the subject’s strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    13
    10
    11
    13
    Units: score on a scale
        arithmetic mean (standard deviation)
    -3.7 ( 2.94 )
    -3.5 ( 4.10 )
    -4.1 ( 3.45 )
    -1.5 ( 2.54 )
    -5.9 ( 5.30 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57

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    End point title
    		 Number of Subjects With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57
    End point description
    The QMG test was used to assess the subject’s strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. Population analyzed included ITT subjects for whom data was available at Day 57.
    End point type
    Secondary
    End point timeframe
    Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    13
    10
    11
    13
    Units: subjects
        3-point Improved
    8
    6
    6
    4
    10
        4-point Improved
    5
    5
    6
    3
    10
        5-point Improved
    5
    5
    5
    1
    8
        6-point Improved
    2
    5
    4
    1
    5
        7-point Improved
    2
    5
    1
    0
    3
        >= 8-point Improved
    2
    3
    1
    0
    3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57

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    End point title
    		 Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57
    End point description
    The MG-QoL15r was used to assess the subject’s limitations related to living with MG. Each of the 15 questions were rated by the subject on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of “over the past few weeks”. The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    14
    12
    13
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.0 ( 4.58 )
    -1.7 ( 4.16 )
    -6.8 ( 5.73 )
    -1.2 ( 1.91 )
    -3.7 ( 5.37 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Serum IgG at Day 57

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    End point title
    		 Change From Baseline in Total Serum IgG at Day 57
    End point description
    Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    12
    13
    10
    11
    13
    Units: gram/liter (g/L)
        arithmetic mean (standard deviation)
    -0.3 ( 1.82 )
    -1.5 ( 1.01 )
    -3.4 ( 1.01 )
    -1.7 ( 1.23 )
    -7.6 ( 2.27 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total MG-ADL Score at Day 85 and 113

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    End point title
    		 Change from Baseline in Total MG-ADL Score at Day 85 and 113
    End point description
    MG-ADL assesses the subject’s MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) on a 4-point rating scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores ranging from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint and 'n' (number analyzed) included the number of subjects evaluated for specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85 and Day 113
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    12
    14
    12
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        Day 85 (n=11, 14, 11, 13, 14)
    -2.2 ( 2.64 )
    -2.1 ( 2.40 )
    -3.7 ( 2.69 )
    -1.9 ( 2.29 )
    -3.6 ( 2.79 )
        Day 113 (n=12, 14, 12, 12, 14)
    -2.6 ( 3.09 )
    -1.0 ( 2.25 )
    -2.8 ( 2.33 )
    -2.4 ( 2.78 )
    -2.6 ( 3.30 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total QMG Score at Day 85 and 113

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    End point title
    		 Change from Baseline in Total QMG Score at Day 85 and 113
    End point description
    The QMG test was used to assess the subject’s strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint and 'n' (number analyzed) included the number of subjects evaluated for specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85 and Day 113
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    10
    14
    10
    9
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        Day 85 (n=10, 13, 9, 9, 13)
    -4.0 ( 2.62 )
    -3.6 ( 3.23 )
    -4.8 ( 2.49 )
    -2.0 ( 2.60 )
    -5.1 ( 3.52 )
        Day 113 (n=9, 14, 10, 9 12)
    -4.7 ( 3.04 )
    -2.1 ( 2.40 )
    -4.2 ( 3.08 )
    -3.2 ( 2.28 )
    -3.3 ( 5.69 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total MG-QoL15r Score at Day 85 and 113

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    End point title
    		 Change from Baseline in Total MG-QoL15r Score at Day 85 and 113
    End point description
    The MG-QoL15r was used to assess the subject’s limitations related to living with MG. Each of the 15 questions were rated by the subject on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of “over the past few weeks”. The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint and 'n' (number analyzed) included the number of subjects evaluated for specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85 and Day 113
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    12
    14
    12
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        Day 85 (n=11, 14, 11, 13, 13)
    -2.5 ( 2.84 )
    -2.9 ( 3.74 )
    -6.5 ( 5.66 )
    -0.7 ( 4.25 )
    -3.5 ( 5.61 )
        Day 113 (n= 12, 14, 12, 12, 13)
    -3.2 ( 3.90 )
    -1.6 ( 4.20 )
    -4.2 ( 4.32 )
    -1.0 ( 2.92 )
    -2.5 ( 6.09 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Shift From Baseline in MGFA Classification to Day 113

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    End point title
    		 Number of Subjects with Shift From Baseline in MGFA Classification to Day 113
    End point description
    MGFA classification identifies subgroup subjects with MG who share distinct clinical features/severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV designed as: “a” if predominant weakness is affecting limb/axial weakness or both; subclass “b” if predominant weakness is affecting oropharyngeal or respiratory muscles or both. Lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 113
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    9
    9
    8
    7
    11
    Units: subjects
        Improved
    3
    2
    3
    2
    3
        Same
    6
    5
    4
    5
    5
        Worsened
    0
    2
    1
    0
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57

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    End point title
    		 Number of Subjects with Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57
    End point description
    MGFA classification identifies subgroup subjects with MG who share distinct clinical features/severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV designed as: “a” if predominant weakness is affecting limb/axial weakness or both; subclass “b” if predominant weakness is affecting oropharyngeal or respiratory muscles or both. Lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    12
    12
    11
    12
    12
    Units: subjects
        Improved
    6
    3
    7
    4
    7
        Same
    6
    9
    3
    8
    4
        Worsened
    0
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Serum IgG at Day 85 and 113

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    End point title
    		 Change From Baseline in Total Serum IgG at Day 85 and 113
    End point description
    Change from baseline in total serum IgG at Day 85 and Day 113 was reported. Blood samples were collected for analysis of total serum IgG. ITT population included all randomized subjects. Here 'N' (number of subjects analyzed) included all subjects who were evaluated for this endpoint and 'n' (number analyzed) included the number of subjects evaluated for specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85 and Day 113
    End point values
    		 Placebo Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    11
    14
    11
    9
    13
    Units: g/L
    arithmetic mean (standard deviation)
        Day 85 (n=11, 13, 10, 9, 13)
    -0.5 ( 1.02 )
    -1.4 ( 1.93 )
    -3.8 ( 1.28 )
    -1.2 ( 1.02 )
    -5.7 ( 2.30 )
        Day 113 (n= 10,14, 11, 9, 12)
    -0.6 ( 1.19 )
    -0.7 ( 1.48 )
    -1.2 ( 0.78 )
    -0.7 ( 1.09 )
    -2.2 ( 1.73 )
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Nipocalimab

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    End point title
    		 Serum Concentrations of Nipocalimab [5]
    End point description
    Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (less than [<] LLOQ) that is < 0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics. The safety population included all subjects who received any amount of nipocalimab or placebo. Here 'n' (number analyzed) included the number of subjects evaluated for specific timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for all the arms of Baseline period.
    End point values
    		 Nipocalimab (M281) 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Number of subjects analysed
    14
    13
    13
    14
    Units: micrograms/milliliter (mcg/mL)
    arithmetic mean (standard deviation)
        Baseline (Pre Infusion) (n=14,13, 13,14)
    0.0 ( 0.005 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Baseline (Post Infusion) (n=4, 5, 4, 5)
    117.75 ( 84.835 )
    746.80 ( 47.214 )
    1847.50 ( 153.270 )
    1325.00 ( 616.443 )
        Day 15 (Pre Infusion) (n=14,13, 13,14)
    0.0 ( 0.006 )
    0.01 ( 0.010 )
    27.61 ( 42.167 )
    29.30 ( 36.631 )
        Day 29 (Pre Infusion) (n=14,10, 11,14)
    0.0 ( 0.004 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    72.69 ( 152.058 )
        Day 43 (Pre Infusion) (n=14,12, 11,14)
    0.0 ( 0.004 )
    0.01 ( 0.013 )
    0.0 ( 0.0 )
    66.72 ( 85.919 )
        Day 57 (Pre Infusion) (n=13,10, 11,13)
    0.0 ( 0.006 )
    95.40 ( 301.681 )
    0.0 ( 0.0 )
    44.80 ( 68.560 )
        Day 57 (Post Infusion) (n=2, 2, 3, 4)
    49.15 ( 41.507 )
    746.50 ( 96.874 )
    0.0 ( 0.0 )
    1827.50 ( 741.052 )
        Day 85 (n=13, 10, 9, 13)
    0.0 ( 0.007 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.004 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 113
    Adverse event reporting additional description
    The safety population included all subjects who received any amount of nipocalimab or placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.

    Reporting group title
    Nipocalimab 5 milligrams/kilogram (mg/kg)
    Reporting group description
    		 Subjects received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 30 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, subjects received matching placebo on Days 15 and 43.

    Reporting group title
    Nipocalimab 60 mg/kg
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, subjects received matching placebo on Days 15, 29, 43 and 57.

    Reporting group title
    Nipocalimab 60 mg/kg (Q2W)
    Reporting group description
    		 Subjects received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.

    Serious adverse events
    		 Placebo Nipocalimab 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Myasthenia Gravis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Nipocalimab 5 milligrams/kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 14 (71.43%)
    12 / 14 (85.71%)
    8 / 13 (61.54%)
    12 / 13 (92.31%)
    12 / 14 (85.71%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Brachiocephalic Vein Thrombosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Feeling Hot
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Feeling Cold
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Chest Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hernia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vessel Puncture Site Swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Vessel Puncture Site Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Peripheral Swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    1
    Oedema Peripheral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    1
    2
    Malaise
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Infusion Site Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Catarrh
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bacterial Test
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood Pressure Increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    0
    1
    Carbohydrate Antigen 19-9 Increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Helicobacter Test Positive
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Lymphocyte Count Decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    0
    0
    2
    Neutrophil Count Increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urine Analysis Abnormal
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Weight Decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Neutrophil Percentage Increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Limb Injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Muscle Rupture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Muscle Strain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palate Injury
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin Laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    4
    2
    0
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 14 (14.29%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    7
    1
    Dysgeusia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Mononeuropathy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myasthenia Gravis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tension Headache
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Eyelid Ptosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blepharitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
    2 / 14 (14.29%)
         occurrences all number
    1
    1
    1
    3
    2
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    5
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Salivary Hypersecretion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    4
    0
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastric Ulcer
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis Allergic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    1
    0
    0
    3
    Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Swelling Face
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin Swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash Erythematous
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Arthritis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Back Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    1
    1
    Muscle Spasms
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    0
    1
    Muscle Twitching
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Neck Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Spinal Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Asymptomatic Bacteriuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Herpes Zoster
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
    2 / 14 (14.29%)
         occurrences all number
    0
    1
    1
    2
    3
    Pharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Glucose Tolerance Impaired
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2018
    Provided information on potential risks and plans for mitigation to enhance patient safety; Revised inclusion criteria to clarify definition of abstinence, duration of contraception/avoidance of pregnancy following last study treatment for males, and acceptable methods of contraception; Added pregnancy as a drug stopping rule for an individual subject; Added a requirement for approval by regulatory authority(ies) before resuming drug, if study treatment had been temporarily held because of meeting a stopping rule.
    11 Dec 2018
    Added MGFA Clinical Classification as an efficacy assessment, to be done at screening, baseline, Day 57, and Day 113; Expanded the number of study centers from 45 to 60; Added provisions for specific circumstances under which subjects who had an equivocal QuantiFERON®-TB Gold retest, and for subjects who had been treated for hepatitis C virus (HCV) could be enrolled; Added a time window for post-infusion vital sign assessments, and changed positioning of subject for vital sign measurements from supine to recumbent; Added more information about pregnancy reporting procedures (including SAEs associated with a pregnancy after the subject has completed the study and considered possibly related to the study agent), and added a provision for collecting information on pregnancy outcomes; Added a test for urine myoglobin, only to be done if serum creatine kinase was elevated; Clarified the assessments to be completed for subjects who discontinued from study treatment.
    04 Jun 2019
    Changed from plasma to serum for the pharmacokinetic (PK) blood samples; Removed the Day 8 study visit and associated assessments; The infusion duration was reduced and requirements for post-infusion safety procedure/observation were relaxed based on data obtained from a study of nipocalimab infusion rates in healthy adults (MOM-M281-007). Details were provided in the Infusion Manual; Added Grade 3 or higher hypoalbuminemia as an adverse event of special interest; Added a provision to the inclusion criterion to allow enrollment of subjects on immunomodulatory agents whose IgG level is not lower than 75% of the lower limit of normal; Added an inclusion criterion that, under certain conditions, allowed enrollment of subjects who had undergone splenectomy (formerly, splenectomy was exclusionary); Specified that a suicidal ideation score of 4 or 5 on the C-SSRS was exclusionary (Exclusion number 9); Allowed enrollment of subjects with a family history of congenital or hereditary immunodeficiency if the condition was confirmed absent in the subject; Allowed enrollment of subjects with spontaneous resolution of HCV if the serum HCV ribonucleic acid level was negative; Under certain conditions, allowed enrollment of subjects with creatine kinase >= 2*upper limit of normal (ULN) and <5*ULN; Allowed the option for the study center to source the supplies used for placebo and to store the placebo according to the package insert; For subjects not entering the open-label extension study, added a requirement for follow-up of subjects with total serum IgG of <600 milligram/deciliter (mg/dL) at Day 113 until the IgG is >= 600 mg/dL; Relaxed the requirement for administration of the MG-ADL and QMG by a clinician/physician to administration by any trained qualified healthcare professional; Post-infusion samples were no longer required after every infusion, only as specified in the Infusion Manual (after the first infusion and after the Day 57 infusion).

    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.
    Limitations to this study include the small sample sizes of each treatment arm and the study activity disruption due to the COVID-19 pandemic, especially the missed QMG assessments which hampered the analysis of the endpoint.
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    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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