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    Clinical Trial Results:
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2014-004633-96
    Trial protocol
    		 GB   DE   HU   PL   RO   IT  
    Global end of trial date
    23 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3461C00005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02446912
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Forskargatan 18, Sudertalje, Sweden, 151 85
    Public contact
    Global Clinical Leader, AstraZeneca AB, +46 317761000, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Global Clinical Leader, AstraZeneca AB, +46 317761000, 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
    23 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the effect of anifrolumab 300 mg compared to placebo on disease activity as measured by the difference in the proportion of participants who achieve an systemic lupus erythematosus (SLE) responder index of ≥4 (SRI[4]) at Week 52.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/GCP, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Poland: 69
    Country: Number of subjects enrolled
    Romania: 27
    Country: Number of subjects enrolled
    Ukraine: 36
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Brazil: 14
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    Colombia: 10
    Country: Number of subjects enrolled
    Peru: 25
    Country: Number of subjects enrolled
    United States: 186
    Country: Number of subjects enrolled
    Israel: 12
    Worldwide total number of subjects
    457
    EEA total number of subjects
    137
    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)
    437
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the trial at 123 sites in 18 countries worldwide.

    Pre-assignment
    Screening details
    		 Participants reported to the medical screening facility/clinical study site for the eligibility screening within 30 days of first study drug administration. Out of the 847 participants screened for the trial, 390 participants were screen failures and were not randomized and 457 participants were randomized onto the trial.

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anifrolumab 150 mg
    Arm description
    		 Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anifrolumab
    Investigational medicinal product code
    MEDI-546
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg anifrolumab administered via a controlled intravenous infusion (IV) pump into a peripheral vein over at least 30 minutes, every 4 weeks.

    Arm title
    		 Anifrolumab 300 mg
    Arm description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anifrolumab
    Investigational medicinal product code
    MEDI-546
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg anifrolumab administered via a controlled intravenous infusion (IV) pump into a peripheral vein over at least 30 minutes, every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
    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
    Matching placebo administered via a controlled intravenous infusion (IV) pump into a peripheral vein over at least 30 minutes, every 4 weeks.

    Number of subjects in period 1
    		Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Started
    93
    180
    184
    Participants who completed week 52
    80
    153
    157
    Completed
    75
    145
    149
    Not completed
    18
    35
    35
         Severe non-compliance to protocol
    1
    -
    1
         Consent withdrawn by subject
    10
    15
    15
         Adverse event, non-fatal
    3
    13
    5
         Condition under investigation worsened
    -
    1
    1
         Miscellaneous
    2
    2
    4
         Study-specific withdrawal criteria
    1
    -
    -
         Lost to follow-up
    -
    -
    2
         Lack of efficacy
    1
    4
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anifrolumab 150 mg
    Reporting group description
    		 Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Reporting group values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo Total
    Number of subjects
    		 93 180 184 457
    Age Categorical
    Units: Subjects
        <18 years
    		 0 0 0 0
        ≥18 to <65 years
    		 90 169 178 437
        ≥65 years
    		 3 11 6 20
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 40.8 ( 12.05 ) 42.0 ( 11.99 ) 41.0 ( 12.30 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 86 165 171 422
        Male
    		 7 15 13 35
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 1
        Asian
    		 8 11 5 24
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 14 29 23 66
        White
    		 64 125 137 326
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 7 15 18 40
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 20 32 35 87
        Not Hispanic or Latino
    		 73 148 149 370
        Unknown or Not Reported
    		 0 0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 164.02 ( 8.208 ) 162.99 ( 7.829 ) 163.10 ( 8.030 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 73.57 ( 19.469 ) 75.36 ( 20.343 ) 74.69 ( 19.332 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.31 ( 6.812 ) 28.25 ( 6.899 ) 28.09 ( 7.145 ) -

    End points

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    End points reporting groups
    Reporting group title
    Anifrolumab 150 mg
    Reporting group description
    		 Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Subject analysis set title
    Anifrolumab 150 mg high IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with high IFN test results.

    Subject analysis set title
    Anifrolumab 150 mg low IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with low IFN test results.

    Subject analysis set title
    Anifrolumab 300 mg high IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with high IFN test results.

    Subject analysis set title
    Anifrolumab 300 mg low IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with low IFN test results.

    Subject analysis set title
    Placebo high IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 cycles). Participants with high IFN test results.

    Subject analysis set title
    Placebo low IFN test results subgroup
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 cycles). Participants with low IFN test results.

    Subject analysis set title
    Anifrolumab 150 mg Baseline OCS ≥10 mg/day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with a baseline oral corticosteroid (OCS) dose of ≥10 mg/day.

    Subject analysis set title
    Anifrolumab 300 mg Baseline OCS ≥10 mg/day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with a baseline oral corticosteroid (OCS) dose of ≥10 mg/day.

    Subject analysis set title
    Placebo Baseline OCS ≥10 mg/day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 cycles). Participants with a baseline oral corticosteroid (OCS) dose of ≥10 mg/day.

    Subject analysis set title
    Anifrolumab 150 mg CLASI Activity Score ≥10
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score of ≥10.

    Subject analysis set title
    Anifrolumab 300 mg CLASI Activity Score ≥10
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score of ≥10.

    Subject analysis set title
    Placebo CLASI Activity Score ≥10
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 cycles). Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score ≥10.

    Primary: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis with Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    35
    65
    74
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.412 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.2
         upper limit
    		 5.8
    Notes
    [1] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [2] - Nominal p-value
    Statistical analysis title
    		 Analysis of Treatment Difference
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 150 mg v Placebo
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 9.6

    Secondary: Number of Participants Who Achieved a Systemic lupus erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic lupus erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis with Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004) A or 2 or more BILAG-2004 B No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg high IFN test results subgroup Anifrolumab 300 mg high IFN test results subgroup Placebo high IFN test results subgroup
    Number of subjects analysed
    76
    148
    151
    Units: Participants
    30
    53
    59
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg high IFN test results subgroup v Placebo high IFN test results subgroup
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.549 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 7.6
    Notes
    [3] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [4] - Nominal p-value

    Secondary: Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/day in the Sub-group of Participants with Baseline OCS ≥10 mg/day (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/day in the Sub-group of Participants with Baseline OCS ≥10 mg/day (Original Analysis with Restricted Medication Rules)
    End point description
    Maintained OCS reduction was defined by meeting all the following criteria: Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Baseline OCS ≥10 mg/day Anifrolumab 300 mg Baseline OCS ≥10 mg/day Placebo Baseline OCS ≥10 mg/day
    Number of subjects analysed
    48
    103
    102
    Units: Participants
    17
    42
    33
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg Baseline OCS ≥10 mg/day v Placebo Baseline OCS ≥10 mg/day
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.18 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 21.9
    Notes
    [5] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [6] - Nominal p-value

    Secondary: Number of Participants with a ≥50% reduction in CLASI Activity Score at Week 12 in the sub-group of Participants with Baseline CLASI Activity Score ≥10 (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants with a ≥50% reduction in CLASI Activity Score at Week 12 in the sub-group of Participants with Baseline CLASI Activity Score ≥10 (Original Analysis with Restricted Medication Rules)
    End point description
    50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all of the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold before assessment.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Anifrolumab 150 mg CLASI Activity Score ≥10 Anifrolumab 300 mg CLASI Activity Score ≥10 Placebo CLASI Activity Score ≥10
    Number of subjects analysed
    30
    58
    54
    Units: Participants
    15
    24
    14
    Statistical analysis title
    		 Analysis of Treatment
    Comparison groups
    Anifrolumab 300 mg CLASI Activity Score ≥10 v Placebo CLASI Activity Score ≥10
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.054 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 34.3
    Notes
    [7] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [8] - Nominal p-value

    Secondary: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Original Analysis with Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified threshold.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    34
    74
    75
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.905 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 10.6
    Notes
    [9] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [10] - Nominal p-value

    Secondary: Annualized Flare Rate

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    End point title
    		 Annualized Flare Rate
    End point description
    A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Annualized flare rate ratio
        number (not applicable)
    0.62
    0.60
    0.72
    Statistical analysis title
    		 Analysis of Treatment Difference
    Statistical analysis description
    Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening [<10 points vs >=10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]). The logarithm of the follow-up time is used as an offset variable
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.258 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Rate Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.14
    Notes
    [11] - Nominal p-value

    Secondary: Number of Participants who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis with Restricted Medication Rules)

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    End point title
    		 Number of Participants who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis with Restricted Medication Rules)
    End point description
    A BICLA responder was achieved if all of the following criteria was met: All criteria related to SRI(4) (please see primary endpoint) plus: Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    27
    67
    49
    Statistical analysis title
    		 Analysis of Treatment Difference
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 19.7

    Secondary: Number of Participants Reporting One or More Adverse Events (AEs)

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    End point title
    		 Number of Participants Reporting One or More Adverse Events (AEs)
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    80
    161
    145
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting One or More Adverse Events of Special Interest (AESI)

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    End point title
    		 Number of Participants Reporting One or More Adverse Events of Special Interest (AESI)
    End point description
    An AESI is an AE of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by the Investigator to the Sponsor/Sponsor’s delegate. An AESI may be serious or nonserious. The events of interest are serious infections, including non opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, MI, or cardiovascular death). AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    11
    23
    18
    No statistical analyses for this end point

    Secondary: Number of Participants with Markedly Abnormal Vital Signs

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    End point title
    		 Number of Participants with Markedly Abnormal Vital Signs
    End point description
    Vital signs included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    14
    36
    46
    No statistical analyses for this end point

    Secondary: Number of Participants with Markedly Abnormal Physical Examinations

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    End point title
    		 Number of Participants with Markedly Abnormal Physical Examinations
    End point description
    Physical examinations included height and weight. Participants were weighed at each study visit and any medically significant changes were reported. Physical examination values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Markedly Abnormal ECG Scores

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    End point title
    		 Number of Participants with Markedly Abnormal ECG Scores
    End point description
    ECGs documented the date, time, heart rate, QRS duration, PR interval, RR interval, QT, and corrected QT interval, which were calculated using the Fridericia formula. The investigator judged the overall interpretation as normal or abnormal, and if abnormal it was decided as to whether or not the abnormality was clinically significant or not clinically significant.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified SELENA-SLEDAI Flare Index

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    End point title
    		 Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified SELENA-SLEDAI Flare Index
    End point description
    The modified SELENA flare index was completed by the Investigator or delegated/qualified physician. Assessment of flares were scored in comparison to the participant's previous visit and should only include findings which, in the opinion of the Investigator, are due to systemic lupus erythematosus (SLE) disease activity within that timeframe. Flare was defined as any 1 criterion present in either the Mild/Moderate Flare or Severe Flare categories. Number of flares were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    38
    58
    67
    No statistical analyses for this end point

    Secondary: Number of Participants with Markedly Abnormal Laboratory Tests

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    End point title
    		 Number of Participants with Markedly Abnormal Laboratory Tests
    End point description
    Laboratory tests were collected at central clinical laboratories and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    44
    71
    87
    No statistical analyses for this end point

    Secondary: Number of Participants with Suicidal Ideation or Behaviour Assessed via the Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Participants with Suicidal Ideation or Behaviour Assessed via the Columbia Suicide Severity Rating Scale (C-SSRS)
    End point description
    The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior was defined as the number of participants who answered "yes" at any time during the treatment period (Baseline to Week 52) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
        Suicidal ideation|
    1
    2
    2
        Suicidal behaviour|
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score

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    End point title
    		 Change from Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score
    End point description
    PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. A negative change from baseline score indicates improvement in symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    71
    130
    138
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -2.1 ( 4.43 )
    -2.7 ( 5.58 )
    -1.7 ( 5.40 )
    No statistical analyses for this end point

    Post-hoc: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints.
    End point type
    Post-hoc
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    45
    84
    79
    Statistical analysis title
    		 Analysis of Treatment Difference
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4555 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 14.1
    Notes
    [12] - Nominal p-value
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 150 mg v Placebo
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 17.8

    Post-hoc: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints.
    End point type
    Post-hoc
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg high IFN test results subgroup Anifrolumab 300 mg high IFN test results subgroup Placebo high IFN test results subgroup
    Number of subjects analysed
    76
    148
    151
    Units: Participants
    40
    71
    63
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg high IFN test results subgroup v Placebo high IFN test results subgroup
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.261 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    6.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 17.7
    Notes
    [13] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [14] - Nominal p-value

    Post-hoc: Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/day in the Sub-group of Participants with Baseline OCS ≥10 mg/day (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/day in the Sub-group of Participants with Baseline OCS ≥10 mg/day (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    Maintained OCS reduction was defined by meeting all of the following criteria: Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold. Rules regarding use of NSAIDS (criteria used to define Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints.
    End point type
    Post-hoc
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Baseline OCS ≥10 mg/day Anifrolumab 300 mg Baseline OCS ≥10 mg/day Placebo Baseline OCS ≥10 mg/day
    Number of subjects analysed
    48
    103
    102
    Units: Participants
    24
    50
    33
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg Baseline OCS ≥10 mg/day v Placebo Baseline OCS ≥10 mg/day
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.013 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    16.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 29.8
    Notes
    [15] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [16] - Nominal p-value

    Post-hoc: Number of Participants with a ≥50% reduction in CLASI Activity Score at Week 12 in the sub-group of Participants with Baseline CLASI Activity Score ≥10 (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants with a ≥50% reduction in CLASI Activity Score at Week 12 in the sub-group of Participants with Baseline CLASI Activity Score ≥10 (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints..
    End point type
    Post-hoc
    End point timeframe
    Week 12
    End point values
    		 Anifrolumab 150 mg CLASI Activity Score ≥10 Anifrolumab 300 mg CLASI Activity Score ≥10 Placebo CLASI Activity Score ≥10
    Number of subjects analysed
    30
    58
    54
    Units: Participants
    16
    25
    14
    Statistical analysis title
    		 Analysis of Treatment Differences
    Comparison groups
    Anifrolumab 300 mg CLASI Activity Score ≥10 v Placebo CLASI Activity Score ≥10
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.034 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    18.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 36
    Notes
    [17] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [18] - Nominal p-value

    Post-hoc: Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold. Rules regarding use of NSAIDS (criteria used to define participants as non-responders) were not implemented as intended per protocol and were not appropriate based on clinical practice (participant taking NSAIDs deemed as non-responder). Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints.
    End point type
    Post-hoc
    End point timeframe
    Week 24
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    40
    83
    79
    Statistical analysis title
    		 Analysis of Treatment Difference
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.515 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 13.4
    Notes
    [19] - The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    [20] - Nominal p-value

    Post-hoc: Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Post-Hoc Analysis with Revised Restricted Medication Rules)

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    End point title
    		 Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Post-Hoc Analysis with Revised Restricted Medication Rules)
    End point description
    A BICLA responder was achieved if all of the following criteria was met: All criteria related to SRI(4) (please see primary endpoint) plus: Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. Rules regarding use of NSAIDS (criteria used to define participants as non-responders) were not implemented as intended per protocol and were not appropriate based on clinical practice (participant taking NSAIDs deemed as non-responder). Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints
    End point type
    Post-hoc
    End point timeframe
    Week 52
    End point values
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Number of subjects analysed
    93
    180
    184
    Units: Participants
    35
    83
    54
    Statistical analysis title
    		 Analysis of Treatment Difference
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    16.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.7
         upper limit
    		 26.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to End of Trial (Maximum of 60 weeks post first dose)
    Adverse event reporting additional description
    AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. Full analysis set: All participants who had received at least one dose of investigational product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Anifrolumab 150 mg
    Reporting group description
    		 Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)

    Serious adverse events
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 93 (10.75%)
    27 / 180 (15.00%)
    35 / 184 (19.02%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Haemangioma of liver
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Deep vein thrombosis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 180 (1.11%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Food allergy
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Reproductive system and breast disorders
    Endometrial hypertrophy
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 180 (1.11%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Dyspnoea
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Suicide attempt
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Post procedural complication
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Perirenal haematoma
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Angina unstable
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Atrial fibrillation
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Seizure
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Syncope
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropsychiatric lupus
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Anaemia
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ulcerative keratitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Small intestinal obstruction
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Swelling face
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephritis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Chronic kidney disease
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    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
    2 / 93 (2.15%)
    4 / 180 (2.22%)
    5 / 184 (2.72%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture pain
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 93 (1.08%)
    3 / 180 (1.67%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 180 (0.56%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appenicitis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Bronchitis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Gangrene
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    0 / 184 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genital herpes
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Sepsis
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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
    Encephalitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Epididymitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic infection
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    0 / 184 (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%
    Non-serious adverse events
    		 Anifrolumab 150 mg Anifrolumab 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 93 (83.87%)
    157 / 180 (87.22%)
    141 / 184 (76.63%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 93 (5.38%)
    4 / 180 (2.22%)
    9 / 184 (4.89%)
         occurrences all number
    5
    4
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 93 (4.30%)
    5 / 180 (2.78%)
    4 / 184 (2.17%)
         occurrences all number
    5
    8
    5
    Chest pain
         subjects affected / exposed
    1 / 93 (1.08%)
    3 / 180 (1.67%)
    0 / 184 (0.00%)
         occurrences all number
    1
    3
    0
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 93 (3.23%)
    1 / 180 (0.56%)
    5 / 184 (2.72%)
         occurrences all number
    3
    1
    6
    Fatigue
         subjects affected / exposed
    0 / 93 (0.00%)
    4 / 180 (2.22%)
    2 / 184 (1.09%)
         occurrences all number
    0
    5
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 180 (1.11%)
    3 / 184 (1.63%)
         occurrences all number
    2
    2
    3
    Peripheral swelling
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences all number
    2
    1
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    4 / 93 (4.30%)
    11 / 180 (6.11%)
    2 / 184 (1.09%)
         occurrences all number
    6
    12
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 93 (2.15%)
    11 / 180 (6.11%)
    7 / 184 (3.80%)
         occurrences all number
    2
    13
    9
    Epistaxis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    5 / 184 (2.72%)
         occurrences all number
    0
    1
    7
    Psychiatric disorders
    Depression
         subjects affected / exposed
    7 / 93 (7.53%)
    6 / 180 (3.33%)
    5 / 184 (2.72%)
         occurrences all number
    7
    8
    5
    Anxiety
         subjects affected / exposed
    4 / 93 (4.30%)
    4 / 180 (2.22%)
    4 / 184 (2.17%)
         occurrences all number
    4
    5
    5
    Insomnia
         subjects affected / exposed
    3 / 93 (3.23%)
    4 / 180 (2.22%)
    8 / 184 (4.35%)
         occurrences all number
    3
    4
    9
    Investigations
    Blood pressure increased
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 180 (1.11%)
    0 / 184 (0.00%)
         occurrences all number
    2
    3
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    9 / 93 (9.68%)
    16 / 180 (8.89%)
    13 / 184 (7.07%)
         occurrences all number
    17
    37
    32
    Contusion
         subjects affected / exposed
    2 / 93 (2.15%)
    4 / 180 (2.22%)
    3 / 184 (1.63%)
         occurrences all number
    2
    4
    3
    Fall
         subjects affected / exposed
    0 / 93 (0.00%)
    6 / 180 (3.33%)
    4 / 184 (2.17%)
         occurrences all number
    0
    7
    4
    Arthropod bite
         subjects affected / exposed
    0 / 93 (0.00%)
    4 / 180 (2.22%)
    3 / 184 (1.63%)
         occurrences all number
    0
    4
    3
    Rib fracture
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences all number
    2
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 93 (6.45%)
    17 / 180 (9.44%)
    18 / 184 (9.78%)
         occurrences all number
    8
    37
    23
    Migraine
         subjects affected / exposed
    4 / 93 (4.30%)
    5 / 180 (2.78%)
    5 / 184 (2.72%)
         occurrences all number
    4
    6
    6
    Dizziness
         subjects affected / exposed
    2 / 93 (2.15%)
    5 / 180 (2.78%)
    7 / 184 (3.80%)
         occurrences all number
    2
    5
    8
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 93 (1.08%)
    4 / 180 (2.22%)
    3 / 184 (1.63%)
         occurrences all number
    1
    4
    3
    Anaemia
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 180 (0.56%)
    4 / 184 (2.17%)
         occurrences all number
    0
    1
    4
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 180 (1.11%)
    1 / 184 (0.54%)
         occurrences all number
    2
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 93 (8.60%)
    6 / 180 (3.33%)
    14 / 184 (7.61%)
         occurrences all number
    11
    9
    14
    Vomiting
         subjects affected / exposed
    4 / 93 (4.30%)
    9 / 180 (5.00%)
    4 / 184 (2.17%)
         occurrences all number
    7
    9
    6
    Nausea
         subjects affected / exposed
    3 / 93 (3.23%)
    9 / 180 (5.00%)
    14 / 184 (7.61%)
         occurrences all number
    5
    10
    19
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 93 (4.30%)
    5 / 180 (2.78%)
    6 / 184 (3.26%)
         occurrences all number
    4
    5
    6
    Dyspepsia
         subjects affected / exposed
    6 / 93 (6.45%)
    3 / 180 (1.67%)
    5 / 184 (2.72%)
         occurrences all number
    6
    6
    5
    Abdominal pain
         subjects affected / exposed
    2 / 93 (2.15%)
    4 / 180 (2.22%)
    2 / 184 (1.09%)
         occurrences all number
    2
    6
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 93 (1.08%)
    4 / 180 (2.22%)
    8 / 184 (4.35%)
         occurrences all number
    1
    5
    11
    Constipation
         subjects affected / exposed
    1 / 93 (1.08%)
    4 / 180 (2.22%)
    2 / 184 (1.09%)
         occurrences all number
    1
    4
    2
    Abdominal distension
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 180 (0.00%)
    0 / 184 (0.00%)
         occurrences all number
    2
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 180 (0.56%)
    5 / 184 (2.72%)
         occurrences all number
    1
    1
    5
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    3 / 93 (3.23%)
    0 / 180 (0.00%)
    1 / 184 (0.54%)
         occurrences all number
    3
    0
    1
    Rash
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    5 / 184 (2.72%)
         occurrences all number
    1
    0
    5
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 93 (0.00%)
    4 / 180 (2.22%)
    0 / 184 (0.00%)
         occurrences all number
    0
    5
    0
    Endocrine disorders
    Steroid withdrawal syndrome
         subjects affected / exposed
    0 / 93 (0.00%)
    5 / 180 (2.78%)
    1 / 184 (0.54%)
         occurrences all number
    0
    5
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 93 (2.15%)
    11 / 180 (6.11%)
    3 / 184 (1.63%)
         occurrences all number
    3
    13
    5
    Back pain
         subjects affected / exposed
    2 / 93 (2.15%)
    10 / 180 (5.56%)
    13 / 184 (7.07%)
         occurrences all number
    2
    10
    16
    Fibromyalgia
         subjects affected / exposed
    3 / 93 (3.23%)
    2 / 180 (1.11%)
    4 / 184 (2.17%)
         occurrences all number
    3
    2
    4
    Pain in extremity
         subjects affected / exposed
    3 / 93 (3.23%)
    2 / 180 (1.11%)
    1 / 184 (0.54%)
         occurrences all number
    3
    2
    1
    Myalgia
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 180 (1.11%)
    5 / 184 (2.72%)
         occurrences all number
    3
    2
    6
    Osteoarthritis
         subjects affected / exposed
    3 / 93 (3.23%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences all number
    4
    1
    1
    Trigger finger
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 180 (0.00%)
    0 / 184 (0.00%)
         occurrences all number
    2
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    4 / 184 (2.17%)
         occurrences all number
    1
    0
    5
    Muscle spasms
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 180 (0.56%)
    4 / 184 (2.17%)
         occurrences all number
    1
    1
    4
    Osteoporosis
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 180 (0.00%)
    4 / 184 (2.17%)
         occurrences all number
    1
    0
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 93 (16.13%)
    36 / 180 (20.00%)
    24 / 184 (13.04%)
         occurrences all number
    18
    58
    28
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 93 (18.28%)
    22 / 180 (12.22%)
    19 / 184 (10.33%)
         occurrences all number
    25
    27
    27
    Urinary tract infection
         subjects affected / exposed
    8 / 93 (8.60%)
    22 / 180 (12.22%)
    26 / 184 (14.13%)
         occurrences all number
    10
    29
    32
    Bronchitis
         subjects affected / exposed
    7 / 93 (7.53%)
    15 / 180 (8.33%)
    9 / 184 (4.89%)
         occurrences all number
    9
    17
    11
    Pharyngitis
         subjects affected / exposed
    6 / 93 (6.45%)
    12 / 180 (6.67%)
    13 / 184 (7.07%)
         occurrences all number
    8
    13
    15
    Herpes zoster
         subjects affected / exposed
    5 / 93 (5.38%)
    10 / 180 (5.56%)
    3 / 184 (1.63%)
         occurrences all number
    5
    10
    3
    Sinusitis
         subjects affected / exposed
    5 / 93 (5.38%)
    8 / 180 (4.44%)
    12 / 184 (6.52%)
         occurrences all number
    6
    12
    13
    Pneumonia
         subjects affected / exposed
    4 / 93 (4.30%)
    4 / 180 (2.22%)
    2 / 184 (1.09%)
         occurrences all number
    5
    4
    2
    Gastroenteritis
         subjects affected / exposed
    5 / 93 (5.38%)
    5 / 180 (2.78%)
    2 / 184 (1.09%)
         occurrences all number
    5
    5
    3
    Oral herpes
         subjects affected / exposed
    0 / 93 (0.00%)
    8 / 180 (4.44%)
    5 / 184 (2.72%)
         occurrences all number
    0
    10
    8
    Cellulitis
         subjects affected / exposed
    0 / 93 (0.00%)
    6 / 180 (3.33%)
    2 / 184 (1.09%)
         occurrences all number
    0
    6
    2
    Folliculitis
         subjects affected / exposed
    4 / 93 (4.30%)
    3 / 180 (1.67%)
    3 / 184 (1.63%)
         occurrences all number
    5
    4
    3
    Conjunctivitis
         subjects affected / exposed
    2 / 93 (2.15%)
    4 / 180 (2.22%)
    1 / 184 (0.54%)
         occurrences all number
    2
    5
    1
    Influenza
         subjects affected / exposed
    2 / 93 (2.15%)
    3 / 180 (1.67%)
    2 / 184 (1.09%)
         occurrences all number
    2
    3
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 93 (0.00%)
    5 / 180 (2.78%)
    3 / 184 (1.63%)
         occurrences all number
    0
    7
    3
    Rhinitis
         subjects affected / exposed
    1 / 93 (1.08%)
    4 / 180 (2.22%)
    4 / 184 (2.17%)
         occurrences all number
    1
    9
    4
    Tooth infection
         subjects affected / exposed
    0 / 93 (0.00%)
    5 / 180 (2.78%)
    0 / 184 (0.00%)
         occurrences all number
    0
    5
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 93 (2.15%)
    3 / 180 (1.67%)
    4 / 184 (2.17%)
         occurrences all number
    2
    3
    4
    Onychomycosis
         subjects affected / exposed
    0 / 93 (0.00%)
    4 / 180 (2.22%)
    0 / 184 (0.00%)
         occurrences all number
    0
    4
    0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences all number
    2
    1
    1
    Furuncle
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 180 (0.56%)
    1 / 184 (0.54%)
         occurrences all number
    3
    1
    1
    Viral infection
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 180 (0.56%)
    2 / 184 (1.09%)
         occurrences all number
    2
    1
    4
    Cystitis
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 180 (0.56%)
    4 / 184 (2.17%)
         occurrences all number
    1
    1
    4
    Hordeolum
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 180 (0.00%)
    0 / 184 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    3 / 93 (3.23%)
    1 / 180 (0.56%)
    4 / 184 (2.17%)
         occurrences all number
    4
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2016
    HIV testing was added as a screening assessment.
    23 Mar 2016
    The washout periods for certain restricted medications including anakinra, apremilast, atacicept (TACI-Ig), belimumab, and blisibimod (AMG 623) were corrected.
    18 May 2016
    Inclusion and exclusion criteria was clarified. Long term extension (LTE) was also clarified.

    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
    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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