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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS)

    Summary
    EudraCT number
    		 2019-004822-15
    Trial protocol
    		 SE  
    Global end of trial date
    24 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2023
    First version publication date
    04 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GNC-401
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04480307
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GeNeuro Innovation SAS
    Sponsor organisation address
    60A Avenue Rockfeller , Lyon, France, 69008
    Public contact
    Clinical Trials Information, GeNeuro Innovation SAS, +41 22552 4800, contact@geneuro.com
    Scientific contact
    Clinical Trials Information, GeNeuro Innovation SAS, +41 22552 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
    24 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of temelimab following intravenous (IV) administration of 18 mg/kg, 36 mg/kg or 54 mg/kg, in patients with RMS who have been treated with rituximab for at least 1 year
    Protection of trial subjects
    All patients were to be observed for 6 hours following completion of the first IMP infusion and at least 2 hours following completion of the subsequent IMP infusions (2nd to 12th). At Week 48 (and/or Week 46 for the various PD/PK measurements, clinical efficacy, MRI, PD, PK and QoL assessments were performed for comparison with the assessments at Baseline. Safety assessments were carried out at all visits. In case of premature discontinuation of the Investigational Medicinal Product (IMP), the patient was withdrawn from the study. 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, patient becoming pregnant, participation in any other interventional clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2020
    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
    Sweden: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met the inclusion criteria at the Screening visit (within 3 weeks prior to dosing) and at the Baseline visit (Study Day 1 [SD1]) were considered eligible to participate in the clinical study.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Temelimab 18 mg/kg
    Arm description
    		 Temelimab 18 mg/kg given by IV infusion every 4 weeks for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temelimab
    Investigational medicinal product code
    GNbAC1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Temelimab was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution

    Arm title
    		 Temelimab 36 mg/kg
    Arm description
    		 Temelimab 36 mg/kg given by IV infusion every 4 weeks for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temelimab
    Investigational medicinal product code
    GNbAC1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Temelimab was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution

    Arm title
    		 Temelimab 54 mg/kg
    Arm description
    		 Temelimab 54 mg/kg given by IV infusion every 4 weeks for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temelimab
    Investigational medicinal product code
    GNbAC1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Temelimab was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution

    Arm title
    		 Placebo
    Arm description
    		 Placebo given by IV infusion every 4 weeks for 48 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered by IV infusion (200 mL over 2 hours) following dilution into glucose 5% solution

    Number of subjects in period 1
    		Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo
    Started
    11
    10
    10
    10
    Completed
    11
    9
    10
    9
    Not completed
    0
    1
    0
    1
         Consent withdrawn by subject
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Temelimab 18 mg/kg
    Reporting group description
    		 Temelimab 18 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 36 mg/kg
    Reporting group description
    		 Temelimab 36 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 54 mg/kg
    Reporting group description
    		 Temelimab 54 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo given by IV infusion every 4 weeks for 48 weeks

    Reporting group values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Total
    Number of subjects
    		 11 10 10 10 41
    Age categorical
    Adults (18-64 years)
    Units: Subjects
        Adults (18-64 years)
    		 11 10 10 10 41
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.2 ± 7.3 47.9 ± 6.3 45.2 ± 10.2 45.6 ± 9.4 -
    Gender categorical
    Units: Subjects
        Female
    		 7 5 3 6 21
        Male
    		 4 5 7 4 20
    Subject analysis sets

    Subject analysis set title
    Randomised set (RS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients to whom a therapeutic treatment was randomly assigned using an interactive response system. Patients were analysed in their randomisation group whatever the treatment they received

    Subject analysis set title
    Safety set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients having taken at least one dose of IMP. Patients were allocated to the group based on the treatment they received.

    Subject analysis set title
    Per protocol set (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the RS with no major protocol deviations and with at least 9 infusions performed. All protocol deviations were assessed and documented on a case-by-case basis prior to database lock, and deviations considered to have a serious impact on the efficacy results led to the relevant patient being excluded from the set.

    Subject analysis sets values
    		 Randomised set (RS) Safety set (SAF) Per protocol set (PP)
    Number of subjects
    41
    41
    35
    Age categorical
    Adults (18-64 years)
    Units: Subjects
        Adults (18-64 years)
    41
    41
    35
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.4 ± 8.3
    45.4 ± 8.3
    30.2 ± 6.0
    Gender categorical
    Units: Subjects
        Female
    21
    21
    18
        Male
    20
    20
    17

    End points

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    End points reporting groups
    Reporting group title
    Temelimab 18 mg/kg
    Reporting group description
    		 Temelimab 18 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 36 mg/kg
    Reporting group description
    		 Temelimab 36 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 54 mg/kg
    Reporting group description
    		 Temelimab 54 mg/kg given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo given by IV infusion every 4 weeks for 48 weeks

    Subject analysis set title
    Randomised set (RS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients to whom a therapeutic treatment was randomly assigned using an interactive response system. Patients were analysed in their randomisation group whatever the treatment they received

    Subject analysis set title
    Safety set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients having taken at least one dose of IMP. Patients were allocated to the group based on the treatment they received.

    Subject analysis set title
    Per protocol set (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the RS with no major protocol deviations and with at least 9 infusions performed. All protocol deviations were assessed and documented on a case-by-case basis prior to database lock, and deviations considered to have a serious impact on the efficacy results led to the relevant patient being excluded from the set.

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    Analysis of AEs focused on TEAEs, defined as AEs
    End point type
    Primary
    End point timeframe
    From the time the patient received their first dose of IMP until their last study visit +28 days.
    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: Statistics were provided depending on the nature of considered data. This was a Phase IIa study, the primary objective being the safety. No statistical analysis was planned in the SAP for safety endpoints. Numbers and types of Adverse Events were simply described and compared across arms.
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Safety set (SAF)
    Number of subjects analysed
    11
    10
    10
    10
    41
    Units: number
    number (not applicable)
        TEAEs
    10
    9
    10
    9
    38
    No statistical analyses for this end point

    Secondary: Change in MTSat in cortex

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    End point title
    		 Change in MTSat in cortex
    End point description
    Change in magnetisation transfer saturation (MTSat) in cortex at Week 48 compared to Baseline
    End point type
    Secondary
    End point timeframe
    From Baselise at week 48
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Per protocol set (PP)
    Number of subjects analysed
    9
    9
    6
    7
    24
    Units: number
        arithmetic mean (standard deviation)
    0.037 ± 0.058
    0.044 ± 0.044
    -0.013 ± 0.077
    0.018 ± 0.040
    0.027 ± 0.061
    Statistical analysis title
    		 ANCOVA analysis
    Statistical analysis description
    Change in MTSat in Cortex from Baseline at Week 48 was analysed using a parametric analysis of covariance (ANCOVA) including Baseline and treatment as factor
    Comparison groups
    Temelimab 18 mg/kg v Temelimab 36 mg/kg v Temelimab 54 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9472
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.052
         upper limit
    		 0.049
    Statistical analysis title
    		 Bayesian analyses
    Statistical analysis description
    In addition, exploratory Bayesian analysis was done using a non-informative prior on the mean observed difference.
    Comparison groups
    Temelimab 18 mg/kg v Temelimab 36 mg/kg v Temelimab 54 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference of change from Baseline
    Point estimate
    0.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.036
         upper limit
    		 0.059

    Secondary: Change in T1 lesion volume

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    End point title
    		 Change in T1 lesion volume
    End point description
    Change in T1 lesion volume at Week 48 compared to Baseline
    End point type
    Secondary
    End point timeframe
    From Baseline at week 48
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Per protocol set (PP)
    Number of subjects analysed
    9
    9
    9
    8
    27
    Units: number
        arithmetic mean (standard deviation)
    -0.055 ± 0.315
    -0.032 ± 0.686
    0.227 ± 0.405
    -0.044 ± 0.185
    0.047 ± 0.493
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Temelimab 36 mg/kg v Temelimab 54 mg/kg v Temelimab 18 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4027
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.154
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.216
         upper limit
    		 0.524

    Secondary: Change in T2 lesion volume

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    End point title
    		 Change in T2 lesion volume
    End point description
    Change in T2 lesion volume at Week 48 compared to Baseline
    End point type
    Secondary
    End point timeframe
    From Baseline at Week 48
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Per protocol set (PP)
    Number of subjects analysed
    9
    9
    9
    8
    27
    Units: number
        arithmetic mean (standard deviation)
    0.028 ± 0.085
    0.029 ± 0.088
    0.023 ± 0.061
    0.027 ± 0.075
    0.027 ± 0.076
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Temelimab 18 mg/kg v Temelimab 36 mg/kg v Temelimab 54 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7428
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.051
         upper limit
    		 0.071

    Secondary: Change in brain parenchymal volume fraction

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    End point title
    		 Change in brain parenchymal volume fraction
    End point description
    Change in brain parenchymal volume fraction at Week 48 compared to Baseline
    End point type
    Secondary
    End point timeframe
    From baseline at Week 48
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Per protocol set (PP)
    Number of subjects analysed
    9
    9
    9
    8
    27
    Units: number
        arithmetic mean (standard deviation)
    -0.013 ± 0.011
    -0.021 ± 0.032
    -0.011 ± 0.013
    -0.019 ± 0.017
    -0.015 ± 0.021
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Temelimab 36 mg/kg v Temelimab 18 mg/kg v Temelimab 54 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7314
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.013
         upper limit
    		 0.018

    Secondary: Change in thalamic volume fraction

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    End point title
    		 Change in thalamic volume fraction
    End point description
    Change in thalamic volume fraction at Week 48 compared to Baseline
    End point type
    Secondary
    End point timeframe
    From baseline at Week 48
    End point values
    		 Temelimab 18 mg/kg Temelimab 36 mg/kg Temelimab 54 mg/kg Placebo Per protocol set (PP)
    Number of subjects analysed
    9
    9
    9
    8
    27
    Units: number
        arithmetic mean (standard deviation)
    -0.000 ± 0.000
    -0.000 ± 0.000
    -0.000 ± 0.000
    -0.000 ± 0.000
    -0.000 ± 0.000
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Temelimab 18 mg/kg v Temelimab 36 mg/kg v Temelimab 54 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7662
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Analysis of AEs focused on TEAEs, defined as AEs that occurred from the time the patient sign the informed consent onwards until the patient's last study visit +28 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Temelimab 18 mg/mL
    Reporting group description
    		 Temelimab 18 mg/mL given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 36 mg/mL
    Reporting group description
    		 Temelimab 36 mg/mL given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Temelimab 54 mg/mL
    Reporting group description
    		 Temelimab 54 mg/mL given by IV infusion every 4 weeks for 48 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Temelimab 18 mg/mL Temelimab 36 mg/mL Temelimab 54 mg/mL Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 Temelimab 18 mg/mL Temelimab 36 mg/mL Temelimab 54 mg/mL Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 11 (90.91%)
    9 / 10 (90.00%)
    10 / 10 (100.00%)
    9 / 10 (90.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    3
    1
    1
    2
    Fatigue
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prostatic disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    0
    1
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    depression
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    2
    1
    Fall
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Animal bite
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Patella fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Tooth fracture
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Balance disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    1
    0
    2
    Vertigo positional
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral mucosal exfoliation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 11 (27.27%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    2
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Back pain
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Limb discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 11 (45.45%)
    4 / 10 (40.00%)
    5 / 10 (50.00%)
    3 / 10 (30.00%)
         occurrences all number
    5
    4
    5
    3
    COVID-19
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    3
    0
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lyme disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Norovirus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Periodontitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 11 (18.18%)
    4 / 10 (40.00%)
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    2
    4
    0
    4

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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