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    Clinical Trial Results:
    A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis

    Summary
    EudraCT number
    		 2016-004935-18
    Trial protocol
    		 HU   DE   CZ   ES   PL   BG   HR   IT  
    Global end of trial date
    14 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2019
    First version publication date
    23 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GNC-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03239860
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GeNeuro SA
    Sponsor organisation address
    Chemin du Pré-Fleuri 3, Plan-les-Ouates, Switzerland, CH-1228
    Public contact
    Clinical Trials Information, GeNeuro SA, 0041 22 552 4800, contact@geneuro.com
    Scientific contact
    Clinical Trials Information, GeNeuro SA, 0041 22 552 4800, contact@geneuro.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
    14 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the long term safety of GNbAC1 in patients with RRMS.
    Protection of trial subjects
    In case of premature discontinuation of the Investigational Medicinal Product, the patient was withdrawn from the study. After discontinuation of the IMP, the investigator was allowed to introduce a new treatment. Reasons for premature discontinuation of the IMP were: Adverse Events or conditions which, according to the judgement of the investigator, constituted a hazard to the patient if the treatment with the IMP continued including lack of efficacy; major protocol deviations if they interfered to an unacceptable extent with study procedures or assessments, or if they jeopardised patient’s safety or administration of an unauthorised concomitant treatment; starting of any treatment with MS disease modifying drugs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 52
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Russian Federation: 27
    Country: Number of subjects enrolled
    Ukraine: 87
    Country: Number of subjects enrolled
    Serbia: 22
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    220
    EEA total number of subjects
    84
    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)
    220
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first study drug administration during study GNC-004 was to occur at least 25 days (as the interval between two IMP administrations in study GNC-003 was 28 ± 3 days) and not more than 90 days after the last study drug administration from the previous study (GNC-003).

    Pre-assignment
    Screening details
    		 Inclusion criteria included patients who had completed Period 2 of study GNC-003 (EudraCT number 2015-004059-29), were using highly effective methods of birth control, and the patients had to have tolerated the study drug according to the investigator’s opinion and could have benefitted from receiving long-term treatment with GNbAC1 infusion.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Assessor, Subject
    Blinding implementation details
    Randomisation occurred in the parent study GNC-003 (EudraCT number 2015-004059-29). At entry in the extension study GNC-004, all patients continued, on a dose-blind fashion, on the dose they were administered in Period 2 of study GNC-003 (6, 12 or 18 mg/kg, every 4 weeks, via a 2-h IV infusion). Note: Period 1 of study GNC-003 was placebo-controlled (24 weeks). Patients randomised to the placebo group in Period 1 were re-randomised to GNbAC1 6, 12 or 18 mg/kg (1:1:1) in Period 2 of GNC-003.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GNbAC1 6 mg/kg
    Arm description
    		 GNbAC1 6 mg/kg given by IV infusion every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    GNbAC1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GNbAC1 was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution at doses of 6, 12, or 18 mg/kg, every 4 weeks from Study Day 1 to Week 92.

    Arm title
    		 GNbAC1 12 mg/kg
    Arm description
    		 GNbAC1 12 mg/kg given by IV infusion every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    GNbAC1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GNbAC1 was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution at doses of 6, 12, or 18 mg/kg, every 4 weeks from Study Day 1 to Week 92.

    Arm title
    		 GNbAC1 18 mg/kg
    Arm description
    		 GNbAC1 18 mg/kg given by IV infusion every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    GNbAC1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GNbAC1 was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution at doses of 6, 12, or 18 mg/kg, every 4 weeks from Study Day 1 to Week 92.

    Number of subjects in period 1 [1]
    		GNbAC1 6 mg/kg GNbAC1 12 mg/kg GNbAC1 18 mg/kg
    Started
    74
    68
    77
    Completed
    0
    0
    0
    Not completed
    74
    68
    77
         Consent withdrawn by subject
    7
    4
    9
         Study terminated by Sponsor
    65
    62
    66
         Adverse event, non-fatal
    1
    -
    2
         Sponsor decision due to Adverse Event
    -
    1
    -
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient withdrew consent before receiving any IMP in the frame of study GNC-004 and was therefore not included in the Safety Set, which was the dataset planned for this study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GNbAC1 6 mg/kg
    Reporting group description
    		 GNbAC1 6 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 12 mg/kg
    Reporting group description
    		 GNbAC1 12 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 18 mg/kg
    Reporting group description
    		 GNbAC1 18 mg/kg given by IV infusion every 4 weeks

    Reporting group values
    		 GNbAC1 6 mg/kg GNbAC1 12 mg/kg GNbAC1 18 mg/kg Total
    Number of subjects
    		 74 68 77 219
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 74 68 77 219
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 38.0 (21 to 56) 39.8 (21 to 57) 39.4 (23 to 56) -
    Gender categorical
    Units: Subjects
        Female
    		 52 48 44 144
        Male
    		 22 20 33 75

    End points

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    End points reporting groups
    Reporting group title
    GNbAC1 6 mg/kg
    Reporting group description
    		 GNbAC1 6 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 12 mg/kg
    Reporting group description
    		 GNbAC1 12 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 18 mg/kg
    Reporting group description
    		 GNbAC1 18 mg/kg given by IV infusion every 4 weeks

    Subject analysis set title
    GNbAC1 6 mg/kg / GNbAC1 6 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This treatment group corresponds to patients who had received GNbAC1 6 mg/kg for 48 weeks in study GNC-003 study (during both Periods 1 and 2), and who continued on this dose in study GNC-004.

    Subject analysis set title
    GNbAC1 12 mg/kg / GNbAC1 12 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This treatment group corresponds to patients who had received GNbAC1 12 mg/kg for 48 weeks in study GNC-003 study (during both Periods 1 and 2), and who continued on this dose in study GNC-004.

    Subject analysis set title
    GNbAC1 18 mg/kg / GNbAC1 18 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This treatment group corresponds to patients who had received GNbAC1 18 mg/kg for 48 weeks in study GNC-003 study (during both Periods 1 and 2), and who continued on this dose in study GNC-004.

    Subject analysis set title
    Placebo / GNbAC1 6, 12, 18 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This treatment group corresponds to patients who had received Placebo in Period 1 of study GNC-003, had been re-randomised to GNbAC1 6, 12, or 18 mg/kg (1:1:1) in Period 2 of study GNC-003, and who continued with the same dose in study GNC-004.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The data set planned for this study was the Safety Set, which was to comprise all patients who had taken at least 1 dose of GNbAC1 in the GNC-004 study.

    Primary: Adverse Events

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    End point title
    		 Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to End of 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: Data are summarised for this endpoint per protocol.
    End point values
    		 GNbAC1 6 mg/kg GNbAC1 12 mg/kg GNbAC1 18 mg/kg
    Number of subjects analysed
    74
    68
    77
    Units: number of patients
        Treatment-Emergent Adverse Events
    33
    32
    34
        Serious Adverse Events
    6
    1
    5
    No statistical analyses for this end point

    Secondary: Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Whole Brain, Safety Set

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    End point title
    		 Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Whole Brain, Safety Set
    End point description
    In the Whole Brain, there was a 15.4% relative reduction in median brain volume loss for the GNbAC1 18 mg/kg / GNbAC1 18 mg/kg group compared to the Comparator group (Placebo / GNbAC1 6, 12, 18 mg/kg).
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    41
    35
    36
    41
    Units: percentage change in brain volume
        median (standard deviation)
    -1.070 ( 1.4785 )
    -1.250 ( 1.1907 )
    -0.880 ( 1.1228 )
    -1.040 ( 1.3981 )
    No statistical analyses for this end point

    Secondary: Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Cerebral Cortical Volume, Safety Set

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    End point title
    		 Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Cerebral Cortical Volume, Safety Set
    End point description
    In the Cerebral Cortex, there was a 41.9% relative reduction in median brain volume loss for the GNbAC1 18 mg/kg / GNbAC1 18 mg/kg compared to the Comparator group (Placebo / GNbAC1 6, 12, 18 mg/kg).
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    39
    34
    36
    41
    Units: percentage change in brain volume
        median (standard deviation)
    -1.270 ( 1.6062 )
    -1.295 ( 1.5342 )
    -0.750 ( 1.2772 )
    -1.290 ( 1.5049 )
    No statistical analyses for this end point

    Secondary: Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Thalamus, Safety Set

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    End point title
    		 Percentage Change in Brain Volume from Baseline in GNC-003 to Extension Week 48 in Thalamus, Safety Set
    End point description
    In the Thalamus, there was a 47.5% and a 42.7% relative reduction in median brain volume loss for the GNbAC1 12 mg/kg / GNbAC1 12 mg/kg and the GNbAC1 18 mg/kg / GNbAC1 18 mg/kg, respectively, compared to the Comparator group (Placebo / GNbAC1 6, 12, 18 mg/kg).
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    40
    34
    36
    41
    Units: percentage change in brain volume
        median (standard deviation)
    -2.310 ( 4.2180 )
    -1.700 ( 3.0428 )
    -1.855 ( 4.0328 )
    -3.240 ( 3.7966 )
    No statistical analyses for this end point

    Secondary: Change in Magnetisation Transfer Ratio (MTR) in Normal-Appearing Periventricular White Matter Band 1 from Baseline in GNC-003 to Extension Week 48, Safety Set

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    End point title
    		 Change in Magnetisation Transfer Ratio (MTR) in Normal-Appearing Periventricular White Matter Band 1 from Baseline in GNC-003 to Extension Week 48, Safety Set
    End point description
    The GNbAC1 18 mg/kg / GNbAC1 18 mg/kg group had a 47.9% relative reduction in median MTR change from Baseline compared to patients in the Comparator Group (Placebo / GNbAC1 6, 12, 18 mg/kg).
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    23
    21
    23
    26
    Units: Change in MTR
        median (standard deviation)
    -3.390 ( 3.7399 )
    -3.550 ( 3.0218 )
    -1.830 ( 4.8409 )
    -3.515 ( 2.0464 )
    No statistical analyses for this end point

    Secondary: Change in Magnetisation Transfer Ratio (MTR) in Cerebral Cortex Band 4 from Baseline in GNC-003 to Extension Week 48, Safety Set

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    End point title
    		 Change in Magnetisation Transfer Ratio (MTR) in Cerebral Cortex Band 4 from Baseline in GNC-003 to Extension Week 48, Safety Set
    End point description
    The GNbAC1 18 mg/kg / GNbAC1 18 mg/kg group had an absolute increase in median MTR compared to the expected decline in patients in the Comparator Group (Placebo / GNbAC1 6, 12, 18 mg/kg) over 96 weeks of treatment across both the GNC-003 and GNC-004 studies.
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    23
    21
    23
    26
    Units: change in MTR
        median (standard deviation)
    -1.120 ( 2.7477 )
    -1.110 ( 2.4042 )
    0.130 ( 3.8599 )
    -1.405 ( 1.6168 )
    No statistical analyses for this end point

    Secondary: Proportion of Patients with Confirmed Worsening in Neurological Disability from Baseline in GNC-003 to Extension Week 48, Safety Set

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    End point title
    		 Proportion of Patients with Confirmed Worsening in Neurological Disability from Baseline in GNC-003 to Extension Week 48, Safety Set
    End point description
    At Week 48, 4 (8.3%) patients in the GNbAC1 6 mg/kg / GNbAC1 6 mg/kg group had worsening disability, compared to 2 (4.8%) patients in the GNbAC1 12 mg/kg / GNbAC1 12 mg/kg group, 2 (3.8%) patients in the GNbAC1 18 mg/kg / GNbAC1 18 mg/kg group, and 5 (9.1%) patients in the Comparator Group (Placebo / GNbAC1 6, 12, 18 mg/kg).
    End point type
    Secondary
    End point timeframe
    Baseline in GNC-003 to Extension (GNC-004) Week 48
    End point values
    		 GNbAC1 6 mg/kg / GNbAC1 6 mg/kg GNbAC1 12 mg/kg / GNbAC1 12 mg/kg GNbAC1 18 mg/kg / GNbAC1 18 mg/kg Placebo / GNbAC1 6, 12, 18 mg/kg
    Number of subjects analysed
    48
    42
    53
    55
    Units: number of patients
    4
    2
    2
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the signing if the informed consent onwards until the patient's last study visist.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    GNbAC1 6 mg/kg
    Reporting group description
    		 GNbAC1 6 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 12 mg/kg
    Reporting group description
    		 GNbAC1 12 mg/kg given by IV infusion every 4 weeks

    Reporting group title
    GNbAC1 18 mg/kg
    Reporting group description
    		 GNbAC1 18 mg/kg given by IV infusion every 4 weeks

    Serious adverse events
    		 GNbAC1 6 mg/kg GNbAC1 12 mg/kg GNbAC1 18 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 74 (8.11%)
    1 / 68 (1.47%)
    5 / 77 (6.49%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Metabolic cardiomyopathy
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervix enlargement
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix haemorrhage uterine
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bartholin's abscess
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 68 (1.47%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endotoxaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pyelonephritis acute
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 68 (1.47%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 GNbAC1 6 mg/kg GNbAC1 12 mg/kg GNbAC1 18 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 74 (44.59%)
    32 / 68 (47.06%)
    34 / 77 (44.16%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 68 (1.47%)
    2 / 77 (2.60%)
         occurrences all number
    0
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    0
    0
    Headache
         subjects affected / exposed
    3 / 74 (4.05%)
    3 / 68 (4.41%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    4
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    2
    0
    1
    Nausea
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 68 (2.94%)
    0 / 77 (0.00%)
         occurrences all number
    0
    3
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 68 (1.47%)
    2 / 77 (2.60%)
         occurrences all number
    2
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 74 (4.05%)
    1 / 68 (1.47%)
    1 / 77 (1.30%)
         occurrences all number
    5
    1
    1
    Back pain
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 68 (2.94%)
    1 / 77 (1.30%)
         occurrences all number
    2
    2
    1
    Muscle spasms
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 68 (1.47%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    1
    0
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 74 (6.76%)
    6 / 68 (8.82%)
    6 / 77 (7.79%)
         occurrences all number
    6
    7
    6
    Oral herpes
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 68 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    3
    0
    1
    Pharyngitis
         subjects affected / exposed
    3 / 74 (4.05%)
    2 / 68 (2.94%)
    2 / 77 (2.60%)
         occurrences all number
    3
    2
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 74 (1.35%)
    3 / 68 (4.41%)
    2 / 77 (2.60%)
         occurrences all number
    1
    3
    2
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 68 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    Tonsillitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 68 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    1
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 74 (2.70%)
    3 / 68 (4.41%)
    6 / 77 (7.79%)
         occurrences all number
    3
    4
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2017
    The protocol was amended to add routine urinary analysis as a safety endpoint to be consistent with the GNC-003 study, to clarify one of the Magnetic Resonance Imaging (MRI) efficacy endpoints to be measured in regions of interest (ROIs) defined by Gadolinium-enhancing and T2 lesions, and to update the number of expected patients in the study to 240. Inconsistencies were corrected and some wording was revised.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Sep 2018
    A company press release was issued on 18th September 2018 to announce that the funding partner for this study had made the strategic decision not to further fund the development of GNbAC1 in Multiple Sclerosis. As the study could no longer be funded, it was decided to terminate the study from this date forward and patients were asked to return to clinic to complete study termination assessments.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This active-only extension study was dose-blind to patients and investigators but not to the sponsor; a 90-day gap was allowed prior to entering the study which resulted in a dosing interruption for most patients; the study was terminated prematurely
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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