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    Clinical Trial Results:
    Tralokinumab in combination with topical corticosteroids for moderate-to-severe atopic dermatitis - ECZTRA 3. A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

    Summary
    EudraCT number
    		 2017-002065-21
    Trial protocol
    		 GB   NL   ES   BE   DE  
    Global end of trial date
    26 Sep 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Apr 2021
    First version publication date
    10 Oct 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Corrections to full data set

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LP0162-1339
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03363854
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ClinicalTrials.gov : NCT03363854
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.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
    26 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis.
    Protection of trial subjects
    This clinical trial was conducted to conform to the principles of the Declaration of Helsinki as adopted by the 18th World Medical Association General Assembly (1964) and subsequent amendments. All subjects received written and verbal information concerning the clinical trial. Subjects were asked to consent that their personal data were recorded, collected, processed and could be transferred to EU and non-EU countries in accordance with any national legislation regulating privacy and data protection. In the treatment period, which consisted of an initial treatment period and a continuation treatment period, some subjects were treated with placebo. If medically necessary (i.e. to control intolerable atopic dermatitis [AD] symptoms), rescue treatment for AD could be provided to subjects at the discretion of the investigator. During the first 3 dosing visits in both the initial treatment period (i.e. at Weeks 0, 2, and 4) and the continuation treatment period (i.e. at Weeks 16, 18, and 20), subjects were monitored after administration of the investigational medicinal product for immediate drug reactions for a minimum of 30 min with vital signs taken at 30 min or until stable, whichever was later. Appropriate drugs, such as epinephrine, anti-histamines, corticosteroids, etc., and medical equipment to treat acute anaphylactic reactions were immediately available at the trial sites and trial personnel was trained to recognise and respond to anaphylaxis according to local guidelines.
    Background therapy
    		 All subjects were required to use an emollient twice daily (or more as needed) for at least 14 days before randomisation and to continue this treatment throughout the trial until the end of the safety follow-up period.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    United Kingdom: 34
    Country: Number of subjects enrolled
    United States: 100
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Poland: 67
    Worldwide total number of subjects
    380
    EEA total number of subjects
    220
    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)
    356
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After the subject gave informed consent, they went through a 2- to 6-week screening period for washout of previous atopic dermatitis medication and disallowed medication. The subject was randomised to treatment at Week 0.

    Period 1
    Period 1 title
    Initial treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Subjects were randomised to initial treatment at Week 0. This was a double-blinded trial where tralokinumab and placebo were visually distinct from each other and not matched for viscosity. They were therefore handled and administered by a qualified unblinded health care professional at the site who was not involved in the management of trial subjects and who did not perform any of the assessments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Initial treatment period - Tralokinumab Q2W+TCS
    Arm description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    		 Initial treatment period - Placebo+TCS
    Arm description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Number of subjects in period 1
    		Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Started
    253
    127
    Completed
    235
    120
    Not completed
    18
    7
         Consent withdrawn by subject
    6
    1
         Subject not dosed
    1
    1
         Adverse event, non-fatal
    5
    1
         Other
    1
    3
         Lost to follow-up
    4
    -
         Lack of efficacy
    1
    1
    Period 2
    Period 2 title
    Continuation treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Subjects who achieved Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 were re-randomised to continuation treatment at Week 16. The other subjects were assigned treatment in a blinded manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuation treatment period - Tralokinumab R/Q2W+TCS
    Arm description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    		 Continuation treatment period - Tralokinumab R/Q4W+TCS
    Arm description
    		 Subjects treated with tralokinumab every second week and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received alternating doses of 300 mg tralokinumab and placebo every second week from Week 16 to Week 30. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    		 Continuation treatment period - Tralokinumab NR/Q2W+TCS
    Arm description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator’s Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    		 Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS
    Arm description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator’s Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    		 Continuation treatment period - Placebo R/placebo+TCS
    Arm description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered placebo Q2W from Week 16 to Week 30. The injections were administered in the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Number of subjects in period 2 [1]
    		Continuation treatment period - Tralokinumab R/Q2W+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS Continuation treatment period - Tralokinumab NR/Q2W+TCS Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS Continuation treatment period - Placebo R/placebo+TCS
    Started
    69
    69
    95
    79
    41
    Completed
    68
    65
    87
    72
    38
    Not completed
    1
    4
    8
    7
    3
         Consent withdrawn by subject
    -
    1
    1
    2
    1
         Adverse event, non-fatal
    -
    1
    -
    2
    1
         Other
    1
    2
    2
    2
    1
         Lost to follow-up
    -
    -
    2
    -
    -
         Lack of efficacy
    -
    -
    3
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Between the initial and continuation treatment periods, 2 subjects permanently discontinued treatment.
    Period 3
    Period 3 title
    Safety follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    No treatment was administered to the subjects during the safety follow-up period and therefore no randomisation took place. However, double blinding was maintained throughout the period.

    Arms
    Arm title
    		 Subjects in the safety follow-up period
    Arm description
    		 Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during this period. In selected countries, eligible subjects who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
    Arm type
    		 No treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [2]
    		Subjects in the safety follow-up period
    Started
    278
    Completed
    62
    Not completed
    216
         Consent withdrawn by subject
    16
         Transferred to extension trial
    180
         Other
    8
         Lost to follow-up
    12
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects could start the safety follow-up (SFU) period at any time during the trial, not only after the continuation treatment period. Among the 330 subjects who completed continuation treatment, 242 entered SFU, 84 transferred to a long extension trial without entering SFU, and 4 withdrew from the trial without entering SFU. 278 subjects entered SFU, 36 after withdrawal in the initial period, 16 after withdrawal in the continuation period, and 242 after continuation treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Initial treatment period - Tralokinumab Q2W+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.

    Reporting group title
    Initial treatment period - Placebo+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.

    Reporting group values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS Total
    Number of subjects
    		 253 127 380
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 237 119 356
        From 65-84 years
    		 16 8 24
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.8 ( 15.3 ) 37.7 ( 14.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 128 43 171
        Male
    		 125 84 209

    End points

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    End points reporting groups
    Reporting group title
    Initial treatment period - Tralokinumab Q2W+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.

    Reporting group title
    Initial treatment period - Placebo+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
    Reporting group title
    Continuation treatment period - Tralokinumab R/Q2W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).

    Reporting group title
    Continuation treatment period - Tralokinumab R/Q4W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).

    Reporting group title
    Continuation treatment period - Tralokinumab NR/Q2W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator’s Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).

    Reporting group title
    Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS
    Reporting group description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator’s Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).

    Reporting group title
    Continuation treatment period - Placebo R/placebo+TCS
    Reporting group description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator’s Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue medication, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
    Reporting group title
    Subjects in the safety follow-up period
    Reporting group description
    		 Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during this period. In selected countries, eligible subjects who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.

    Primary: Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16

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    End point title
    		 Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16
    End point description
    IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe). The analysis was based on the full analysis set (FAS). Of the 380 subjects randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 subjects.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    98
    33
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects who achieved IGA 0 or 1 at Week 16 were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 21.9
    Notes
    [1] - The primary endpoints were tested sequentially at a 5% significance level. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.

    Primary: Subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) at Week 16

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    End point title
    		 Subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) at Week 16
    End point description
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set (FAS). Of the 380 subjects randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 subjects.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    141
    45
    Statistical analysis title
    		 Tralokinumab Q2W+TCS
    Statistical analysis description
    Subjects who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    20.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.8
         upper limit
    		 30.6
    Notes
    [2] - The primary endpoints were tested sequentially at a 5% significance level. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.

    Secondary: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (weekly average) of at least 4 from baseline to Week 16

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    End point title
    		 Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (weekly average) of at least 4 from baseline to Week 16
    End point description
    Worst Daily Pruritus NRS is used by the subject to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale. The analysis was based on subjects in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    249
    126
    Units: Number of subjects
    113
    43
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.
    Comparison groups
    Initial treatment period - Placebo+TCS v Initial treatment period - Tralokinumab Q2W+TCS
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 21.6
    Notes
    [3] - This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints, if these showed statistical significance.

    Secondary: Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16

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    End point title
    		 Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16
    End point description
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: units on a scale
        least squares mean (standard error)
    -37.7 ( 1.25 )
    -26.8 ( 1.80 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    -10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 -6.6
    Notes
    [4] - This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints, if these showed statistical significance.

    Secondary: Change in Dermatology Life Quality Index (DLQI) score from baseline to Week 16

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    End point title
    		 Change in Dermatology Life Quality Index (DLQI) score from baseline to Week 16
    End point description
    DLQI is used by the subject to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: units on a scale
        least squares mean (standard error)
    -11.7 ( 0.39 )
    -8.8 ( 0.56 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -1.6
    Notes
    [5] - This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints, if these showed statistical significance.

    Secondary: Frequency of anti-drug antibodies (ADA)

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    End point title
    		 Frequency of anti-drug antibodies (ADA)
    End point description
    Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period. The analysis was based on the safety analysis set (378 participants). Data was collected for the treatment groups applicable in each treatment period, i.e. tralokinumab Q2W+TCS and placebo+TCS treatment groups in the initial treatment period and the 5 continuation treatment groups (see table below) in the continuation treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16, Week 16 to Week 32
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Continuation treatment period - Tralokinumab R/Q2W+TCS Initial treatment period - Placebo+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS Continuation treatment period - Tralokinumab NR/Q2W+TCS Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS Continuation treatment period - Placebo R/placebo+TCS
    Number of subjects analysed
    252
    66
    126
    65
    92
    77
    39
    Units: Number of subjects
        Positive
    2
    0
    3
    2
    0
    3
    2
        Perishing
    1
    0
    0
    0
    0
    0
    0
        Negative
    246
    66
    123
    63
    92
    74
    37
        No post-baseline ADA assessment
    3
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Amount of topical corticosteroid (TCS) used through Week 16 assuming no TCS used from the non-returned tubes

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    End point title
    		 Amount of topical corticosteroid (TCS) used through Week 16 assuming no TCS used from the non-returned tubes
    End point description
    Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits. The results of Week 15-16 are reported below. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    Week 1-2 to Week 15-16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    229
    108
    Units: gram(s)
        least squares mean (standard error)
    11.6 ( 1.57 )
    20.2 ( 2.27 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [6]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    -8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 -3.2
    Notes
    [6] - The statistical test was not controlled for multiplicity.

    Secondary: Amount of topical corticosteroid (TCS) used through Week 16 assuming all TCS used from the non-returned tubes

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    End point title
    		 Amount of topical corticosteroid (TCS) used through Week 16 assuming all TCS used from the non-returned tubes
    End point description
    Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits. The results of Week 15-16 are reported below. The analysis was based on the full analysis set
    End point type
    Secondary
    End point timeframe
    Week 1-2 to Week 15-16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    229
    108
    Units: gram(s)
        least squares mean (standard error)
    15.3 ( 2.26 )
    24.8 ( 3.27 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [7]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.3
         upper limit
    		 -1.7
    Notes
    [7] - The statistical test was not controlled for multiplicity.

    Secondary: Number of atopic dermatitis flares through Week 16

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    End point title
    		 Number of atopic dermatitis flares through Week 16
    End point description
    Assessed as appearance of new flares since the previous visit. The analysis was based on the full analysis set and the results reported are based on all observed data.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of flares
    119
    75
    No statistical analyses for this end point

    Secondary: Number of days without topical treatment use from baseline to Week 16

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    End point title
    		 Number of days without topical treatment use from baseline to Week 16
    End point description
    Subjects assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis. The analysis was based on the full analysis set and results of Week 16 are reported below.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    210
    96
    Units: days
        least squares mean (standard error)
    3.4 ( 0.19 )
    3.0 ( 0.27 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17 [8]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 1.1
    Notes
    [8] - The statistical test was not controlled for multiplicity.

    Secondary: Subjects achieving at least 50% reduction in Eczema Area and Severity Index (EASI) at Week 16

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    End point title
    		 Subjects achieving at least 50% reduction in Eczema Area and Severity Index (EASI) at Week 16
    End point description
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    200
    73
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    21.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 31.3
    Notes
    [9] - The statistical test was not controlled for multiplicity.

    Secondary: Subjects achieving at least 90% reduction in Eczema Area and Severity Index (EASI) at Week 16

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    End point title
    		 Subjects achieving at least 90% reduction in Eczema Area and Severity Index (EASI) at Week 16
    End point description
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    83
    27
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.1
         upper limit
    		 20.7
    Notes
    [10] - The statistical test was not controlled for multiplicity.

    Secondary: Change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score

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    End point title
    		 Change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score
    End point description
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    229
    108
    Units: Units on a scale
        least squares mean (standard error)
    -21.0 ( 0.67 )
    -15.6 ( 0.96 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [11]
    Method
    		 Repeated measurement model
    Parameter type
    		 Difference
    Point estimate
    -5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 -3.1
    Notes
    [11] - The statistical test was not controlled for multiplicity.

    Secondary: Subjects achieving at least 50% reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

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    End point title
    		 Subjects achieving at least 50% reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
    End point description
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    154
    48
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    22.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 33.3
    Notes
    [12] - The statistical test was not controlled for multiplicity.

    Secondary: Subjects achieving at least 75% reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

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    End point title
    		 Subjects achieving at least 75% reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
    End point description
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    252
    126
    Units: Number of subjects
    60
    16
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 19
    Notes
    [13] - The statistical test was not controlled for multiplicity.

    Secondary: Change from baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (weekly average)

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    End point title
    		 Change from baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (weekly average)
    End point description
    Worst Daily Pruritus NRS is used by the subject to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale. The analysis was based on the full analysis set.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    221
    100
    Units: Units on a scale
        least squares mean (standard error)
    -4.1 ( 0.15 )
    -2.9 ( 0.21 )
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [14]
    Method
    		 Repeated measurements model
    Parameter type
    		 Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -0.7
    Notes
    [14] - The statistical test was not controlled for multiplicity.

    Secondary: Reduction from baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at least 4 points among participants with baseline DLQI ≥4

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    End point title
    		 Reduction from baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at least 4 points among participants with baseline DLQI ≥4
    End point description
    DLQI is used by the subject to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL. The analysis was based on subjects in the full analysis set with DLQI of at least 4 at baseline (Week 0).
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 16
    End point values
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS
    Number of subjects analysed
    248
    123
    Units: Number of subjects
    207
    81
    Statistical analysis title
    		 Tralokinumab Q2W+TCS vs placebo+TCS
    Statistical analysis description
    Subjects meeting the endpoint were defined as responders. Subjects with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16. The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
    Comparison groups
    Initial treatment period - Tralokinumab Q2W+TCS v Initial treatment period - Placebo+TCS
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 27.1
    Notes
    [15] - The statistical test was not controlled for multiplicity.

    Secondary: Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 32 among subjects with IGA score of 0 or 1 at Week 16 after initial randomisation to tralokinumab

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    End point title
    		 Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 32 among subjects with IGA score of 0 or 1 at Week 16 after initial randomisation to tralokinumab
    End point description
    IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe). The analysis was based on the subjects in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved IGA score of 0 or 1 at Week 16 without rescue medication. Subjects with missing data at Week 16 or who received rescue medication prior to Week 32 were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 32
    End point values
    		 Continuation treatment period - Tralokinumab R/Q2W+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS
    Number of subjects analysed
    48
    49
    Units: Number of subjects
    43
    38
    No statistical analyses for this end point

    Secondary: Subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) at Week 32 among subjects who had achieved at least 75% reduction in EASI at Week 16 after initial randomisation to tralokinumab

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    End point title
    		 Subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) at Week 32 among subjects who had achieved at least 75% reduction in EASI at Week 16 after initial randomisation to tralokinumab
    End point description
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition. The analysis was based on subjects in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved at least 75% reduction in EASI at Week 16 without rescue medication. Subjects with missing data at Week 16 or who received rescue medication prior to Week 32 were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 32
    End point values
    		 Continuation treatment period - Tralokinumab R/Q2W+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS
    Number of subjects analysed
    67
    65
    Units: Number of subjects
    62
    59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow up period (Week 32 to Week 46).
    Adverse event reporting additional description
    The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Initial treatment period - Tralokinumab Q2W+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Subjects received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.

    Reporting group title
    Initial treatment period - Placebo+TCS
    Reporting group description
    		 Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Subjects were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

    Reporting group title
    Continuation treatment period - Tralokinumab R/Q2W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 or a reduction in EASI of at least 75% achieved without rescue medication, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Subjects received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.

    Reporting group title
    Continuation treatment period - Tralokinumab R/Q4W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 or a reduction in EASI of at least 75% at Week 16 achieved without rescue medication, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32). Subjects received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.

    Reporting group title
    Continuation treatment period - Tralokinumab NR/Q2W+TCS
    Reporting group description
    		 Subjects treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having IGA score of 0 or 1 at Week 16 or a reduction in EASI of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Subjects received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.

    Reporting group title
    Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS
    Reporting group description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having IGA score of 0 or 1 at Week 16 or a reduction in EASI of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Subject received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.

    Reporting group title
    Continuation treatment period - Placebo R/placebo+TCS
    Reporting group description
    		 Subjects treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 or a reduction in EASI of at least 75% at Week 16 achieved without rescue medication, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Subjects were administered placebo Q2W from Week 16 to Week 30.

    Reporting group title
    Safety follow-up period - All treatment groups
    Reporting group description
    		 Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during the safety follow-up period. In selected countries, eligible subjects who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.

    Serious adverse events
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS Continuation treatment period - Tralokinumab R/Q2W+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS Continuation treatment period - Tralokinumab NR/Q2W+TCS Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS Continuation treatment period - Placebo R/placebo+TCS Safety follow-up period - All treatment groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 252 (0.79%)
    4 / 126 (3.17%)
    3 / 69 (4.35%)
    0 / 69 (0.00%)
    2 / 95 (2.11%)
    0 / 79 (0.00%)
    1 / 41 (2.44%)
    3 / 278 (1.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    1 / 41 (2.44%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 95 (1.05%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroduodenitis
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 126 (0.79%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 95 (1.05%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 126 (0.79%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 126 (0.79%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 126 (0.79%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 126 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 95 (0.00%)
    0 / 79 (0.00%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Initial treatment period - Tralokinumab Q2W+TCS Initial treatment period - Placebo+TCS Continuation treatment period - Tralokinumab R/Q2W+TCS Continuation treatment period - Tralokinumab R/Q4W+TCS Continuation treatment period - Tralokinumab NR/Q2W+TCS Continuation treatment period -Placebo NR/tralokinumab Q2W+TCS Continuation treatment period - Placebo R/placebo+TCS Safety follow-up period - All treatment groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    118 / 252 (46.83%)
    36 / 126 (28.57%)
    30 / 69 (43.48%)
    24 / 69 (34.78%)
    41 / 95 (43.16%)
    32 / 79 (40.51%)
    12 / 41 (29.27%)
    10 / 278 (3.60%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 252 (8.73%)
    6 / 126 (4.76%)
    2 / 69 (2.90%)
    5 / 69 (7.25%)
    7 / 95 (7.37%)
    2 / 79 (2.53%)
    1 / 41 (2.44%)
    3 / 278 (1.08%)
         occurrences all number
    26
    9
    2
    5
    7
    2
    1
    3
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    17 / 252 (6.75%)
    0 / 126 (0.00%)
    5 / 69 (7.25%)
    4 / 69 (5.80%)
    5 / 95 (5.26%)
    2 / 79 (2.53%)
    0 / 41 (0.00%)
    0 / 278 (0.00%)
         occurrences all number
    30
    0
    14
    9
    5
    2
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 252 (3.17%)
    2 / 126 (1.59%)
    4 / 69 (5.80%)
    1 / 69 (1.45%)
    1 / 95 (1.05%)
    2 / 79 (2.53%)
    2 / 41 (4.88%)
    1 / 278 (0.36%)
         occurrences all number
    8
    2
    4
    1
    2
    2
    2
    1
    Nausea
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 126 (0.79%)
    3 / 69 (4.35%)
    4 / 69 (5.80%)
    3 / 95 (3.16%)
    1 / 79 (1.27%)
    0 / 41 (0.00%)
    2 / 278 (0.72%)
         occurrences all number
    0
    1
    3
    4
    4
    1
    0
    2
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    6 / 252 (2.38%)
    10 / 126 (7.94%)
    1 / 69 (1.45%)
    1 / 69 (1.45%)
    8 / 95 (8.42%)
    6 / 79 (7.59%)
    2 / 41 (4.88%)
    2 / 278 (0.72%)
         occurrences all number
    8
    12
    1
    1
    8
    7
    2
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    28 / 252 (11.11%)
    4 / 126 (3.17%)
    4 / 69 (5.80%)
    0 / 69 (0.00%)
    3 / 95 (3.16%)
    3 / 79 (3.80%)
    1 / 41 (2.44%)
    0 / 278 (0.00%)
         occurrences all number
    32
    4
    4
    0
    3
    3
    1
    0
    Oral herpes
         subjects affected / exposed
    4 / 252 (1.59%)
    1 / 126 (0.79%)
    3 / 69 (4.35%)
    4 / 69 (5.80%)
    4 / 95 (4.21%)
    2 / 79 (2.53%)
    1 / 41 (2.44%)
    0 / 278 (0.00%)
         occurrences all number
    6
    2
    3
    4
    5
    2
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    19 / 252 (7.54%)
    6 / 126 (4.76%)
    7 / 69 (10.14%)
    3 / 69 (4.35%)
    6 / 95 (6.32%)
    3 / 79 (3.80%)
    2 / 41 (4.88%)
    2 / 278 (0.72%)
         occurrences all number
    21
    7
    8
    3
    7
    3
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    49 / 252 (19.44%)
    14 / 126 (11.11%)
    12 / 69 (17.39%)
    9 / 69 (13.04%)
    20 / 95 (21.05%)
    15 / 79 (18.99%)
    7 / 41 (17.07%)
    0 / 278 (0.00%)
         occurrences all number
    64
    18
    13
    10
    28
    15
    8
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2018
    The main reason for the amendment was a change in the procedure for safety monitoring of trial subjects after administration of the investigational medicinal product. This change was based on the evaluation of safety data from both completed and ongoing trials with tralokinumab in atopic dermatitis and asthma which warranted a shorter observation period.
    29 Aug 2018
    The main reason for the amendment was to introduce the possibility for eligible subjects in selected countries to participate to an open-label long-term extension trial (conducted under a separate protocol) without completing the safety follow-up period in the present trial. This was due to the availability of a new anti-drug antibodies (ADA) assay with improved tralokinumab tolerance making it possible to detect the presence or absence of ADA in the presence of tralokinumab. This was not possible with the previous assay and ADA sampling at the end of the 14-week off-treatment safety follow-up period was therefore originally required for ADA evaluation. Thus, in selected countries, the new ADA assay allowed eligible subjects who had completed treatment in the present trial to continue into the long-term extension trial without completing the safety follow-up period in the present trial. These subjects had their safety follow-up period after end of treatment in the long-term extension trial.

    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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