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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations

    Summary
    EudraCT number
    		 2016-003246-93
    Trial protocol
    		 HU   PL  
    Global end of trial date
    17 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2019
    First version publication date
    07 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3461C00008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02962960
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Global Clinical Lead, AstraZeneca, 1 3013985799, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, 1 3013985799, ClinicalTrialTransparency@astrazeneca.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
    17 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the PK and PD of 150 mg and 300 mg anifrolumab administered as SC injections Q2W as measured by anifrolumab concentrations, PK parameters, 21-gene type I IFN PD signature score and neutralisation ratio at Week 12.
    Protection of trial subjects
    The study was conducted in compliance with the Declaration of Helsinki ethical principles and also in compliance with International Conference on Harmonization Good Clinical Practice Guidelines. Local regulatory requirements to protect safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 12
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    36
    EEA total number of subjects
    24
    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)
    35
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants type I Interferon (IFN) test-high Systemic Lupus Erythematosus (SLE) subjects with active skin manifestations while receiving Standard of Care (SOC) treatment were eligible for the study.

    Pre-assignment
    Screening details
    		 In total, 48 patients were enrolled from 12 participating sites in 4 countries. Twelve patients were enrolled but not randomized due to ineligibility. Of the enrolled patients, 36 patients were randomized, and all received at least one dose of study treatment.

    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, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    The study was double-blinded with respect to anifrolumab or placebo, but not to dose level (1 or 2 injections). The study was kept blind up until analyses of at Week 12. Randomization was performed via IXRS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anifrolumab - Lower dose
    Arm description
    		 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anifrolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150mg as added to SOC, given Q2W as one SC injection in a volume of 1mL

    Arm title
    		 Anifrolumab - Higher dose
    Arm description
    		 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anifrolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg as added to SOC, given Q2W as two SC injections in a volume of 1mL each

    Arm title
    		 Placebo Comparator
    Arm description
    		 Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg (300mg) as added to SOC, given Q2W as one (two) SC injection(s) in a volume of 1mL (each)

    Number of subjects in period 1
    		Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Started
    14
    13
    9
    Completed
    11
    11
    9
    Not completed
    3
    2
    0
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    1
    1
    -
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anifrolumab - Lower dose
    Reporting group description
    		 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50

    Reporting group title
    Anifrolumab - Higher dose
    Reporting group description
    		 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50

    Reporting group title
    Placebo Comparator
    Reporting group description
    		 Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50

    Reporting group values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator Total
    Number of subjects
    		 14 13 9 36
    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)
    		 14 13 8 35
        From 65-84 years
    		 0 0 1 1
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.3 ( 9.1 ) 41.5 ( 9.2 ) 47.8 ( 14.2 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 12 12 8 32
        Male
    		 2 1 1 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 14 13 9 36
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 6 2 0 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 8 11 9 28
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Placebo Comparator to lower dose
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of care, from week 0 to week 50

    Subject analysis set title
    Placebo Comparator to higher dose
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of care, from week 0 to week 50

    Subject analysis sets values
    		 Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects
    5
    4
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    4
    4
        From 65-84 years
    1
    0
        85 years and over
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    49.5 ( 14.5 )
    46.0 ( 15.8 )
    Sex: Female, Male
    Units: Subjects
        Female
    5
    3
        Male
    0
    1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    0
        Not Hispanic or Latino
    5
    4
        Unknown or Not Reported
    0
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    0
    0
        White
    5
    4
        More than one race
    0
    0
        Unknown or Not Reported
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Anifrolumab - Lower dose
    Reporting group description
    		 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50

    Reporting group title
    Anifrolumab - Higher dose
    Reporting group description
    		 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50

    Reporting group title
    Placebo Comparator
    Reporting group description
    		 Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50

    Subject analysis set title
    Placebo Comparator to lower dose
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of care, from week 0 to week 50

    Subject analysis set title
    Placebo Comparator to higher dose
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of care, from week 0 to week 50

    Primary: Maximum concentration of anifrolumab in serum after first dose

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    End point title
    		 Maximum concentration of anifrolumab in serum after first dose [1]
    End point description
    Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.
    End point type
    Primary
    End point timeframe
    Week 0
    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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    13
    13
    0 [2]
    Units: mcg/mL
        geometric mean (geometric coefficient of variation)
    14.058 ( 49.8151 )
    28.115 ( 74.4916 )
    ( )
    Notes
    [2] - Placebo subjects were not included in PK analyses
    No statistical analyses for this end point

    Primary: Steady-state serum trough (predose) concentration (Ctrough) of Anifrolumab

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    End point title
    		 Steady-state serum trough (predose) concentration (Ctrough) of Anifrolumab [3]
    End point description
    Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).
    End point type
    Primary
    End point timeframe
    Week 12
    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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    11
    11
    0 [4]
    Units: mcg/mL
        geometric mean (geometric coefficient of variation)
    15.618 ( 81.3595 )
    16.926 ( 9205.6677 )
    ( )
    Notes
    [4] - Placebo subjects were not included in PK analyses
    No statistical analyses for this end point

    Primary: 21-gene type 1 IFN signature score (fold-change)

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    End point title
    		 21-gene type 1 IFN signature score (fold-change) [5]
    End point description
    21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    11
    11
    9
    Units: fold change
        arithmetic mean (standard deviation)
    3.2 ( 3.69 )
    3.5 ( 5.73 )
    14.3 ( 6.68 )
    No statistical analyses for this end point

    Primary: 21-gene type 1 IFN neutralization ratio (percent suppression of fold change)

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    End point title
    		 21-gene type 1 IFN neutralization ratio (percent suppression of fold change) [6]
    End point description
    21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [6] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    11
    11
    9
    Units: % neutralization
        arithmetic mean (standard deviation)
    77.5 ( 24.16 )
    80.5 ( 36.65 )
    15.1 ( 49.63 )
    No statistical analyses for this end point

    Secondary: Antidrug antibody (ADA)

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    End point title
    		 Antidrug antibody (ADA)
    End point description
    Post-baseline ADA incidence.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    14
    13
    9
    Units: Subject
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Neutralizing antibodies (nAb)

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    End point title
    		 Neutralizing antibodies (nAb)
    End point description
    Incidence of detectable nAb in post-baseline ADA positive participants.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    1
    1
    0 [7]
    Units: Subject
    0
    0
    Notes
    [7] - Only ADA positive subjects are included in this analysis
    No statistical analyses for this end point

    Secondary: Number AEs (Adverse events) and SAEs (serious adverse events), including adverse events of special interest (AESI)

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    End point title
    		 Number AEs (Adverse events) and SAEs (serious adverse events), including adverse events of special interest (AESI)
    End point description
    Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    14
    13
    9
    Units: Subject
        Any adverse event
    12
    11
    7
        Any serious adverse event
    4
    2
    0
        Any adverse event of special interest
    5
    1
    1
    No statistical analyses for this end point

    Secondary: Change from baseline for vital signs

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    End point title
    		 Change from baseline for vital signs [8]
    End point description
    Change from baseline for vital signs.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [8] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure (mmHg) - Week 12
    -4.1 ( 12.08 )
    3 ( 6.63 )
    -5.8 ( 13.99 )
    7.3 ( 8.96 )
        Systolic Blood Pressure (mmHg) - Week 52
    2.1 ( 10.96 )
    -1.7 ( 12.96 )
    3.4 ( 8.53 )
    12.5 ( 19.36 )
        Systolic Blood Pressure (mmHg) - Week 60
    4.1 ( 19.70 )
    -2.8 ( 14.91 )
    12.2 ( 8.61 )
    4.5 ( 7.14 )
        Diastolic Blood Pressure (mmHg) - Week 12
    -2.0 ( 10.02 )
    2.4 ( 6.71 )
    -3.8 ( 6.50 )
    4.3 ( 4.35 )
        Diastolic Blood Pressure (mmHg) - Week 52
    0.1 ( 6.87 )
    2.9 ( 7.54 )
    -0.4 ( 7.13 )
    6.8 ( 5.38 )
        Diastolic Blood Pressure (mmHg) - Week 60
    3.6 ( 12.23 )
    -0.8 ( 6.86 )
    -1.0 ( 8.22 )
    8.8 ( 6.29 )
    No statistical analyses for this end point

    Secondary: Change from baseline for physical examination

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    End point title
    		 Change from baseline for physical examination [9]
    End point description
    Physical examination is reported as change from baseline in body weight.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [9] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: kilograms
    arithmetic mean (standard deviation)
        Week 12
    -1.81 ( 2.674 )
    1.37 ( 3.113 )
    0.7 ( 1.889 )
    0.98 ( 2.904 )
        Week 52
    -2.83 ( 4.683 )
    2.52 ( 6.495 )
    0.30 ( 3.338 )
    3.90 ( 5.608 )
        Week 60
    -1.81 ( 3.858 )
    2.93 ( 6.463 )
    1.06 ( 4.020 )
    3.60 ( 5.300 )
    No statistical analyses for this end point

    Secondary: Change from baseline for 12-lead ECG

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    End point title
    		 Change from baseline for 12-lead ECG [10]
    End point description
    The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done. No occurrence of abnormal (CS) was observed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    Notes
    [10] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: Subject
        Normal at baseline - Normal at Week 52
    7
    10
    5
    3
        Normal at baseline - Abnormal (NCS) at Week 52
    1
    1
    0
    0
        Normal at baseline - not done at Week 52
    1
    2
    0
    0
        Abnormal (NCS) at baseline - Normal at Week 52
    2
    0
    0
    1
        Abnormal (NCS) baseline - Abnormal (NCS) Week 52
    1
    0
    0
    0
        Abnormal (NCS) at baseline - not done at Week 52
    2
    0
    0
    0
        Not done at baseline - Normal at Week 52
    0
    0
    0
    0
        Not done at baseline - Abnormal (NCS) at Week 52
    0
    0
    0
    0
        Not done at baseline - Not done at Week 52
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Value of Haematology blood tests to detect change from baseline

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    End point title
    		 Value of Haematology blood tests to detect change from baseline [11]
    End point description
    Change from baseline in haematology blood tests (haemoglobin, leucocytes [particle concentration], platelets [particle concentration]) are reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [11] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: According to blood test measure
    arithmetic mean (standard deviation)
        Haemoglobin (g/L) - Week 12
    -0.2 ( 9.07 )
    0.7 ( 7.4 )
    -0.5 ( 7.14 )
    4.8 ( 5.91 )
        Haemoglobin (g/L) - Week 52
    -1.1 ( 13.92 )
    0.1 ( 11.65 )
    -4.8 ( 3.83 )
    7 ( 5.94 )
        Haemoglobin (g/L) - Week 60
    0.8 ( 12.97 )
    0 ( 10.43 )
    -5.4 ( 5.68 )
    5.8 ( 6.85 )
        Leucocytes (10^9/L) - Week 12
    0.491 ( 1.5806 )
    3.165 ( 2.2706 )
    0.867 ( 1.0999 )
    1.96 ( 1.9487 )
        Leucocytes (10^9/L) - Week 52
    1.041 ( 1.5794 )
    2.457 ( 2.3891 )
    0.236 ( 1.0107 )
    0.080 ( 1.4798 )
        Leucocytes (10^9/L) - Week 60
    -0.012 ( 1.5489 )
    1.474 ( 1.6490 )
    0.776 ( 2.1779 )
    1.23 ( 1.6687 )
        Platelets (10^9/L) - Week 12
    7.8 ( 65.28 )
    45.2 ( 67.41 )
    10.3 ( 24.54 )
    17.0 ( 42.58 )
        Platelets (10^9/L) - Week 52
    28.0 ( 74.28 )
    46.1 ( 74.91 )
    6.6 ( 64.24 )
    -2.0 ( 33.85 )
        Platelets (10^9/L) - Week 60
    -19.1 ( 53.48 )
    39.0 ( 60.33 )
    24.4 ( 65.73 )
    -2.8 ( 28.43 )
    No statistical analyses for this end point

    Secondary: Value of Urinalysis tests to detect change from baseline

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    End point title
    		 Value of Urinalysis tests to detect change from baseline [12]
    End point description
    Change from baseline in urinalysis (total protein and protein-creatinine ratio) are reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [12] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: According to urinalysis measure
    arithmetic mean (standard deviation)
        Protein, Total (g/L) - Week 12
    0.7669 ( 2.71221 )
    -0.0744 ( 0.76445 )
    0 ( 0 )
    0.3443 ( 0.34301 )
        Protein, Total (g/L) - Week 52
    -0.0029 ( 0.08124 )
    -0.0011 ( 0.33468 )
    0 ( 0 )
    0.1143 ( 0.24476 )
        Protein, Total (g/L) - Week 60
    0.1151 ( 0.12514 )
    -0.1790 ( 0.83066 )
    0.003 ( 0.00671 )
    0.3975 ( 0.82602 )
        Protein/Creatinine (g/g) - Week 12
    1.37029 ( 5.186672 )
    -0.13007 ( 1.123807 )
    -0.03056 ( 0.056701 )
    0.32764 ( 0.337631 )
        Protein/Creatinine (g/g) - Week 52
    0.03756 ( 0.135157 )
    -0.00465 ( 0.183327 )
    -0.00781 ( 0.047671 )
    0.080930 ( 1.581772 )
        Protein/Creatinine (g/g) - Week 60
    0.02578 ( 0.119862 )
    -0.28836 ( 1.185347 )
    -0.03501 ( 0.061888 )
    0.46178 ( 0.899886 )
    No statistical analyses for this end point

    Secondary: Value of Clinical Chemistry blood tests to detect change from baseline (serum)

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    End point title
    		 Value of Clinical Chemistry blood tests to detect change from baseline (serum) [13]
    End point description
    Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase, Creatinine) are reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [13] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    14
    13
    5
    4
    Units: According to urinalysis measure
    arithmetic mean (standard deviation)
        Alanine Aminotransferase (ukat/L) - Week 12
    0.00769 ( 0.147479 )
    -0.13003 ( 0.431764 )
    -0.05418 ( 0.045905 )
    0.02501 ( 0.134397 )
        Alanine Aminotransferase (ukat/L) - Week 52
    -0.06335 ( 0.119642 )
    -0.05607 ( 0.556152 )
    -0.06335 ( 0.047735 )
    0.04167 ( 0.169182 )
        Alanine Aminotransferase (ukat/L) - Week 60
    -0.01297 ( 0.043131 )
    0.09446 ( 0.365981 )
    -0.04334 ( 0.032495 )
    -0.01667 ( 0.18127 )
        Aspartate Aminotransferase (ukat/L) - Week 12
    -0.01154 ( 0.065765 )
    -0.10502 ( 0.169099 )
    0.00417 ( 0.059911 )
    0.03334 ( 0.105430 )
        Aspartate Aminotransferase (ukat/L) - Week 52
    -0.04834 ( 0.066424 )
    -0.05304 ( 0.196369 )
    0.00333 ( 0.090847 )
    0.09169 ( 0.100482 )
        Aspartate Aminotransferase (ukat/L) - Week 60
    -0.01111 ( 0.058937 )
    0.04816 ( 0.123752 )
    0 ( 0.050010 )
    -0.02501 ( 0.099555 )
        Creatinine (umol/L) - Week 12
    4.385 ( 8.5799 )
    -3.6 ( 11.2467 )
    5.5 ( 6.3509 )
    5.25 ( 9.8446 )
        Creatinine (umol/L) - Week 52
    12.2 ( 33.2597 )
    -7.273 ( 19.5862 )
    0.2 ( 13.9714 )
    2.5 ( 5.5076 )
        Creatinine (umol/L) - Week 60
    7.316 ( 8.7449 )
    -5.556 ( 12.8463 )
    5.0 ( 10.4163 )
    6.5 ( 12.5033 )
    No statistical analyses for this end point

    Secondary: Value of Inflammatory marker panel blood tests to detect change from baseline

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    End point title
    		 Value of Inflammatory marker panel blood tests to detect change from baseline
    End point description
    Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator
    Number of subjects analysed
    14
    13
    9
    Units: mm
    arithmetic mean (standard deviation)
        ESR - Week 12
    -3.0 ( 20.37 )
    -7.2 ( 15.46 )
    -11.9 ( 15.36 )
        ESR - Week 52
    5.6 ( 25.58 )
    -6.7 ( 12.25 )
    -16.0 ( 10.95 )
        ESR - Week 60
    14.6 ( 38.77 )
    -1.0 ( 21.84 )
    2.2 ( 22.48 )
    No statistical analyses for this end point

    Secondary: Value of Autoantibody blood panel blood tests to detect change from baseline

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    End point title
    		 Value of Autoantibody blood panel blood tests to detect change from baseline [14]
    End point description
    Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [14] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    9
    8
    3
    3
    Units: IU/mL
    arithmetic mean (standard deviation)
        anti-dsDNA - Week 12
    -42.09 ( 256.228 )
    -84.97 ( 231.489 )
    -37.0 ( 19.799 )
    -97.33 ( 151.596 )
        anti-dsDNA - Week 52
    -99.04 ( 288.183 )
    8.70 ( 27.308 )
    -13.0 ( 50.229 )
    -76.87 ( 127.433 )
        anti-dsDNA - Week 60
    52.67 ( 144.220 )
    16.53 ( 30.528 )
    -21.33 ( 54.921 )
    -76.73 ( 141.525 )
    No statistical analyses for this end point

    Secondary: Value of Infection-related blood tests to detect change from baseline

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    End point title
    		 Value of Infection-related blood tests to detect change from baseline [15]
    End point description
    Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 60
    Notes
    [15] - 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: Results are only reported by descriptive statistics, no formal comparisons were performed in this trial.
    End point values
    		 Anifrolumab - Lower dose Anifrolumab - Higher dose Placebo Comparator to lower dose Placebo Comparator to higher dose
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    Units: Subject
        Positive post-baseline
    Notes
    [16] - No subjects with Hepatitis B core antibody positive at screening
    [17] - No subjects with Hepatitis B core antibody positive at screening
    [18] - No subjects with Hepatitis B core antibody positive at screening
    [19] - No subjects with Hepatitis B core antibody positive at screening
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Adverse event reporting additional description
    An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of IMP plus 14 days). This change may or may not be caused by the treatment being studied.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Anifrolumab - Lower dose
    Reporting group description
    		 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50

    Reporting group title
    Placebo Comparator
    Reporting group description
    		 Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50

    Reporting group title
    Anifrolumab - Higher dose
    Reporting group description
    		 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50

    Serious adverse events
    		 Anifrolumab - Lower dose Placebo Comparator Anifrolumab - Higher dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (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
    Gastrointestinal disorders
    Mouth Ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Lupus Nephritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic Lupus Erythematosus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Herpes Zoster
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis Media Acute
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Anifrolumab - Lower dose Placebo Comparator Anifrolumab - Higher dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 14 (85.71%)
    7 / 9 (77.78%)
    11 / 13 (84.62%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Anembryonic Gestation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Face Oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Feeling Hot
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Reproductive system and breast disorders
    Endometrial Hyperplasia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal Inflammation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal Septum Perforation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural Effusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Productive Cough
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Panic Attack
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Mycobacterium Tuberculosis Complex Test Positive
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Subcutaneous Haematoma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pericardial Cyst
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    0
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Syncope
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Myopia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Uveitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Dental Caries
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 9 (22.22%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    0
    Food Poisoning
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Paraesthesia Oral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Miliaria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Renal Impairment
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    1
    Osteoporosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Spinal Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Abscess Limb
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Acute Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 9 (11.11%)
    3 / 13 (23.08%)
         occurrences all number
    1
    1
    5
    Conjunctivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Conjunctivitis Viral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes Zoster
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    Influenza
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
         occurrences all number
    3
    1
    2
    Pharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 14 (35.71%)
    3 / 9 (33.33%)
    1 / 13 (7.69%)
         occurrences all number
    9
    3
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1

    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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    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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