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    Clinical Trial Results:
    A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

    Summary
    EudraCT number
    		 2011-004812-40
    Trial protocol
    		 DE   NL   CZ   IT   GB  
    Global end of trial date
    19 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2016
    First version publication date
    02 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2211C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01482884
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D Mölndal
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, S-431 83
    Public contact
    Mark Berner Hansen, AstraZeneca R&D Mölndal, +46 31 776 4794, Mark.Berner.Hansen@astrazeneca.com
    Scientific contact
    Mark Berner Hansen, AstraZeneca R&D Mölndal, +46 31 776 4794, Mark.Berner.Hansen@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
    19 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Clinical response at week 8 based on Mayo score Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
    Protection of trial subjects
    No specific measures where put in place to protect trials subjects. Anti-pain treatment was based on local practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    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
    Czech Republic: 19
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    United Kingdom: 14
    Worldwide total number of subjects
    147
    EEA total number of subjects
    147
    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)
    143
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 147/111 patients were enrolled/randomized from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013.

    Pre-assignment
    Screening details
    		 Participants were enrolled for a period of 3 weeks.

    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
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tralokinumab
    Arm description
    		 Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    CAT-354
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Number of subjects in period 1 [1]
    		Tralokinumab Placebo
    Started
    56
    55
    Completed
    43
    37
    Not completed
    13
    18
         Consent withdrawn by subject
    8
    13
         Medical decision due to lack of efficacy
    -
    1
         Adverse event, non-fatal
    2
    1
         Lost to follow-up
    2
    2
         Protocol deviation
    1
    -
         Lack of efficacy
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 147 patients were enrolled from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013. Out of 147 enrolled patients, 36 did not meet the eligibility criteria and 1 was randomized but not treated. Therefore 111 patients were randomized in total.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tralokinumab
    Reporting group description
    		 Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.

    Reporting group values
    		 Tralokinumab Placebo Total
    Number of subjects
    		 56 55 111
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 56 54 110
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 42.2 ( 11.54 ) 40.8 ( 13.26 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 29 29 58
        Male
    		 27 26 53
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 2 0 2
        White
    		 54 54 108
        Other
    		 0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 2 2 4
        Asian (Other than Chinese And Japanese)
    		 2 0 2
        Not Applicable
    		 35 40 75
        Other
    		 17 13 30
    Study Specific Characteristic
    Yes: if participants had received a glucocorticosteroid treatment prior to baseline and the outcome of that treatment was no improvement. No: If the outcome of the treatment was improvement or missing. Unknown: If the outcome of the treatment was unknown.
    Units: Subjects
        Yes
    		 3 8 11
        No
    		 53 46 99
        Unknown
    		 0 1 1
    Study Specific Characteristic |
    Units: Years
        arithmetic mean (standard deviation)
    		 9.22 ( 8.523 ) 7.78 ( 8.664 ) -
    Study Specific Characteristic |
    Mayo score at baseline
    Units: Scores on scale
        arithmetic mean (full range (min-max))
    		 8.36 (5 to 11) 8.33 (6 to 11) -
    Study Specific Characteristic |
    Partial Mayo score at baseline
    Units: Scores on scale
        arithmetic mean (full range (min-max))
    		 5.91 (3 to 8) 5.85 (3 to 8) -
    Subject analysis sets

    Subject analysis set title
    The full analysis set consist of all randomised participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set consist of all randomised participants

    Subject analysis sets values
    		 The full analysis set consist of all randomised participants
    Number of subjects
    111
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    110
        From 65-84 years
    1
        85 years and over
    0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    41.5 ( 12.39 )
    Gender, Male/Female
    Units: Participants
        Female
    58
        Male
    53
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    2
        White
    108
        Other
    1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    4
        Asian (Other than Chinese And Japanese)
    2
        Not Applicable
    75
        Other
    30
    Study Specific Characteristic
    Yes: if participants had received a glucocorticosteroid treatment prior to baseline and the outcome of that treatment was no improvement. No: If the outcome of the treatment was improvement or missing. Unknown: If the outcome of the treatment was unknown.
    Units: Subjects
        Yes
    11
        No
    99
        Unknown
    1
    Study Specific Characteristic |
    Units: Years
        arithmetic mean (standard deviation)
    8.51 ( 8.585 )
    Study Specific Characteristic |
    Mayo score at baseline
    Units: Scores on scale
        arithmetic mean (full range (min-max))
    8.34 (5 to 11)
    Study Specific Characteristic |
    Partial Mayo score at baseline
    Units: Scores on scale
        arithmetic mean (full range (min-max))
    5.88 (3 to 8)

    End points

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    End points reporting groups
    Reporting group title
    Tralokinumab
    Reporting group description
    		 Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.

    Subject analysis set title
    The full analysis set consist of all randomised participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set consist of all randomised participants

    Primary: Clinical response at week 8 based on Mayo score

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    End point title
    		 Clinical response at week 8 based on Mayo score
    End point description
    Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
    End point type
    Primary
    End point timeframe
    Eight week treatment period
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: Percentage of responders
        number (not applicable)
    37.5
    32.7
    Statistical analysis title
    		 Cochran-Mantel-Haenszel (CMH) chi-square test
    Statistical analysis description
    The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.
    Comparison groups
    Tralokinumab v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4062 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 22.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0905
    Notes
    [1] - Glucocorticosteroid-refractory status as stratification factor

    Secondary: Change in Mayo score from baseline to Week 8

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    End point title
    		 Change in Mayo score from baseline to Week 8
    End point description
    Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.
    End point type
    Secondary
    End point timeframe
    Eight week treatment period
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    45
    42
    Units: Score on scale
        least squares mean (standard error)
    -2.41 ( 0.58 )
    -1.92 ( 0.56 )
    Statistical analysis title
    		 ANCOVA Analysis of Covariance
    Comparison groups
    Tralokinumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3937
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.63
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.57

    Secondary: Mucosal healing at week 8 based on Mayo score

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    End point title
    		 Mucosal healing at week 8 based on Mayo score
    End point description
    Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.
    End point type
    Secondary
    End point timeframe
    Eight week treatment period
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: Percentage of participants
        number (not applicable)
    32.1
    20
    Statistical analysis title
    		 Cochran-Mantel-Haenszel (CMH) chi-square test
    Comparison groups
    Tralokinumab v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1043 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 28.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0825
    Notes
    [2] - Glucocorticosteroid-refractory status as stratification factor

    Secondary: Clinical remission at week 8 based on Mayo score

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    End point title
    		 Clinical remission at week 8 based on Mayo score
    End point description
    Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
    End point type
    Secondary
    End point timeframe
    Eight week treatment period
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: Percentage of participants
        number (not applicable)
    17.9
    5.5
    Statistical analysis title
    		 Cochran-Mantel-Haenszel (CMH) chi-square test
    Comparison groups
    Tralokinumab v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0326 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 24.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0596
    Notes
    [3] - Glucocorticosteroid-refractory status as stratification factor

    Secondary: Change from baseline in partial Mayo score

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    End point title
    		 Change from baseline in partial Mayo score
    End point description
    The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4, 8, 12, 16, 20, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: Score on scale
    arithmetic mean (full range (min-max))
        Week 4
    -1.8 (-8 to 3)
    -0.8 (-6 to 4)
        Week 8
    -2.4 (-6 to 3)
    -1.7 (-6 to 1)
        Week 12
    -2.7 (-7 to 3)
    -2.6 (-8 to 4)
        Week 16
    -2.6 (-7 to 3)
    -3.3 (-7 to 2)
        Week 20
    -3 (-7 to 2)
    -3.6 (-8 to 1)
        Week 24
    -3 (-7 to 3)
    -3.6 (-7 to 1)
    No statistical analyses for this end point

    Secondary: Change from baseline in modified Riley score

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    End point title
    		 Change from baseline in modified Riley score
    End point description
    Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.
    End point type
    Secondary
    End point timeframe
    Eight week treatment period
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    37
    35
    Units: Grade on scale
        least squares mean (standard error)
    -0.49 ( 0.23 )
    -0.74 ( 0.24 )
    Statistical analysis title
    		 ANCOVA Analysis of Covariance
    Comparison groups
    Tralokinumab v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.449
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33

    Secondary: Change from baseline in C - reactive protein

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    End point title
    		 Change from baseline in C - reactive protein
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4, 8, 12, 16, 20, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: mg/L
    arithmetic mean (full range (min-max))
        Week 4
    -2.755 (-33 to 25)
    0.51 (-12 to 32)
        Week 8
    -1.089 (-29 to 29)
    0.637 (-43 to 46)
        Week 12
    -2.795 (-46 to 63)
    -1.974 (-61 to 43)
        Week 16
    -3.49 (-53 to 19)
    0.638 (-61 to 97)
        Week 20
    -4.094 (-52 to 43)
    -1.467 (-62 to 31)
        Week 24
    -2.754 (-36 to 25)
    -1.915 (-59 to 36)
    No statistical analyses for this end point

    Secondary: Change from baseline in Albumin

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    End point title
    		 Change from baseline in Albumin
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4, 8, 12, 16, 20, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: g/L
    arithmetic mean (full range (min-max))
        Week 4
    0 (-8 to 5)
    -0.7 (-7 to 6)
        Week 8
    0.8 (-7 to 8)
    -0.2 (-8 to 5)
        Week 12
    0.3 (-9 to 5)
    -0.4 (-8 to 5)
        Week 16
    0.5 (-10 to 12)
    0.4 (-7 to 7)
        Week 20
    1.1 (-4 to 7)
    0.1 (-6 to 9)
        Week 24
    1.2 (-4 to 8)
    0.2 (-6 to 8)
    No statistical analyses for this end point

    Secondary: Change from baseline in Calprotectin

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    End point title
    		 Change from baseline in Calprotectin
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4, 8, 12, 16, 20, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    56
    55
    Units: ug/g
    arithmetic mean (full range (min-max))
        Week 4
    69.45 (-1068 to 931)
    198.8 (-1315 to 4188)
        Week 8
    86.47 (-894.2 to 912)
    -250.52 (-4005 to 4505)
        Week 12
    -39.19 (-1109 to 841)
    50.31 (-1234 to 4811)
        Week 16
    -75.1 (-1008 to 1056)
    -338.76 (-3857 to 1138)
        Week 20
    32.55 (-1155 to 4669)
    -402.81 (-3835 to 794)
        Week 24
    -136.78 (-1120 to 617)
    -267.58 (-1172 to 824)
    No statistical analyses for this end point

    Secondary: Serum concentration of Tralokinumab

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    End point title
    		 Serum concentration of Tralokinumab
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    55
    0 [4]
    Units: ug/ml
    arithmetic mean (full range (min-max))
        pre-dose at baseline
    0 (0 to 0)
    ( to )
        Week 4
    37.9 (12.2 to 92.2)
    ( to )
        Week 8
    50.2 (5.83 to 116)
    ( to )
        Week 12
    48.2 (0.781 to 109)
    ( to )
        Week 16
    27.2 (0.369 to 82.7)
    ( to )
        Week 20
    9.32 (0.527 to 36.9)
    ( to )
        Week 24
    3.66 (0 to 18)
    ( to )
    Notes
    [4] - Serum concentration is not reported for placebo patients therefore no data available.
    No statistical analyses for this end point

    Secondary: Immunogenicity

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    End point title
    		 Immunogenicity
    End point description
    Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.
    End point type
    Secondary
    End point timeframe
    Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
    End point values
    		 Tralokinumab Placebo
    Number of subjects analysed
    55
    55
    Units: participants
        pre-dose at baseline
    0
    1
        Week 8
    0
    1
        Week 12
    0
    1
        Week 16
    0
    1
        Week 24
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.

    Reporting group title
    Tralokinumab 300 mg
    Reporting group description
    		 Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.

    Serious adverse events
    		 Placebo Tralokinumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 55 (10.91%)
    7 / 55 (12.73%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    SERUM SICKNESS
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS ULCERATIVE
         subjects affected / exposed
    5 / 55 (9.09%)
    5 / 55 (9.09%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Tralokinumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 55 (67.27%)
    41 / 55 (74.55%)
    Investigations
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    Cardiac disorders
    TACHYCARDIA
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    12 / 55 (21.82%)
    10 / 55 (18.18%)
         occurrences all number
    22
    35
    DIZZINESS
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 55 (5.45%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    5 / 55 (9.09%)
    5 / 55 (9.09%)
         occurrences all number
    6
    5
    FATIGUE
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    10
    INJECTION SITE REACTION
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    PYREXIA
         subjects affected / exposed
    4 / 55 (7.27%)
    6 / 55 (10.91%)
         occurrences all number
    4
    7
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 55 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    6 / 55 (10.91%)
    7 / 55 (12.73%)
         occurrences all number
    9
    13
    COLITIS ULCERATIVE
         subjects affected / exposed
    10 / 55 (18.18%)
    11 / 55 (20.00%)
         occurrences all number
    12
    13
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 55 (5.45%)
         occurrences all number
    1
    3
    TOOTHACHE
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 55 (5.45%)
         occurrences all number
    1
    3
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    ABDOMINAL TENDERNESS
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    DIARRHOEA
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    DYSPEPSIA
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    NAUSEA
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    10
    VOMITING
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    3
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 55 (3.64%)
    4 / 55 (7.27%)
         occurrences all number
    2
    5
    COUGH
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    ALOPECIA
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 55 (5.45%)
         occurrences all number
    2
    4
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    7 / 55 (12.73%)
    3 / 55 (5.45%)
         occurrences all number
    7
    3
    BACK PAIN
         subjects affected / exposed
    4 / 55 (7.27%)
    3 / 55 (5.45%)
         occurrences all number
    5
    5
    MUSCLE SPASMS
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    MYALGIA
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Infections and infestations
    INFLUENZA
         subjects affected / exposed
    4 / 55 (7.27%)
    2 / 55 (3.64%)
         occurrences all number
    5
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    5 / 55 (9.09%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3
    PHARYNGITIS
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    3
    2
    SINUSITIS
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2012
    The number of sites increased. The enrollment period prolonged from 12 days to 21 days. Upper age limit extended to allow patients between 65 and 75 years. The required wash-out period after anti-TNF-α treatment was shortened from 12 to 8 weeks.
    22 Nov 2012
    Change in text in the Section 5.4.1 of the CSP, revised text states that “the data related to the primary variable were to be collected for analysis by the designated unblinded sponsor staff or delegates after completion of Visit 6 of all the patients”.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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