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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 6 (ECZema TRAlokinumab trial no.6)

    Summary
    EudraCT number
    2017-005143-33
    Trial protocol
    FR   PL   DE   NL   BE   GB  
    Global end of trial date
    16 Mar 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Oct 2021
    First version publication date
    01 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0162-1334
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03526861
    WHO universal trial number (UTN)
    -
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001900-PIP02-17
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of subcutaneous administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with 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. Subjects and their legally acceptable representative received written and verbal information concerning the clinical trial and were given an opportunity to ask questions and sufficient time to consider before consenting. Subjects not of legal age assented to participation in the trial, and for such subjects, one or more legally authorised representatives provided consent. Subjects or legally authorised representatives were asked to consent to their personal data being recorded, collected, processed and transferred to EU and non-EU countries in accordance with any national legislation regulating privacy and data protection. Some subjects were randomised to initial treatment with placebo, and subjects who achieved a clinical response at Week 16 with placebo were assigned to continue placebo treatment until Week 52. If medically necessary (i.e. to control intolerable atopic dermatitis [AD] symptoms), rescue treatment for AD could be provided to subjects throughout the trial, both during the initial treatment period and the maintenance treatment period, at the discretion of the investigator. For the first 3 investigational medicinal product (IMP) dosing visits in both the initial treatment period (i.e. Weeks 0, 2, and 4) and in open-label treatment, subjects were monitored after IMP administration for immediate drug reactions for a minimum of 2 hours with vital signs taken every 30 minutes or until stable, whichever was later. Vital signs were documented in the electronic case report forms. Appropriate drugs, such as epinephrine, antihistamines, corticosteroids, etc., and medical equipment to treat acute anaphylactic reactions were immediately available at trial sites, and trial personnel was trained to recognise and respond to anaphylaxis according to local guidelines
    Background therapy
    All subjects were to use an emollient twice daily (or more, as needed) for at least 14 days before randomisation and were to continue this treatment throughout the trial.
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 105
    Country: Number of subjects enrolled
    Canada: 52
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Japan: 32
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Poland: 54
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 11
    Worldwide total number of subjects
    301
    EEA total number of subjects
    94
    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)
    301
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Trial start date: 13-Jul-2018. Primary completion date: 15-Apr-2020, Trial completion date: March 16 2021. The trial was conducted in 10 countries: United States, Australia, Canada, United Kingdom, Poland, Belgium, Germany, France, Japan, and the Netherlands.

    Pre-assignment
    Screening details
    The screening period was 2 to 6 weeks and included 1 or 2 visits. The exact duration depended on the washout period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomisation.

    Period 1
    Period 1 title
    Initial treatment period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This was a double-blind trial in which tralokinumab and placebo were visually distinct from each other. The IMP was handled and administered by a qualified, unblinded healthcare professional (HCP) 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 300 mg Q2W
    Arm description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 300 mg Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Initial treatment period - Tralokinumab 150 mg Q2W
    Arm description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 150 mg Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 1 SC injection (1.0 mL) of 150 mg tralokinumab and 1 SC injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Initial treatment period - Placebo Q2W
    Arm description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Number of subjects in period 1
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Started
    101
    100
    100
    Completed
    94
    93
    86
    Not completed
    7
    7
    14
         Excluded from trial+FAS due to quality/GCP issues
    3
    1
    5
         Not dosed
    1
    1
    1
         Discontinued IMP before Week 16
    3
    5
    8
    Period 2
    Period 2 title
    Open-label treatment period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS
    Arm description
    Subjects in the open-label treatment period (Week 16 to Week 52) treated with tralokinumab every second week (Q2W) + optional TCS. Subjects transferred to open-label treatment at Week 16 if they did not achieve protocol-defined clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 OR after Week 16 if they lost clinical response during the maintenance treatment period. Loss of clinical response during the maintenance treatment period was defined as: -IGA of at least 2 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=0 at Week 16 -IGA of at least 3 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=1 at Week 16 -Not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA>1 at Week 1
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 300 mg Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg. IMP was administered by a qualified HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Number of subjects in period 2 [1]
    Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS
    Started
    242
    Completed
    214
    Not completed
    28
         Excluded from trial+FAS due to quality/GCP issues
    8
         Discontinued IMP before Week 52
    19
         Received IMP and withdrew from trial at Week 50
    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: The open-label treatment period was in parallel to the maintenance treatment period. Subjects from the initial treatment period entered either into the open-label treatment period or maintenance treatment period.
    Period 3
    Period 3 title
    Maintenance treatment period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This was a double-blind trial in which tralokinumab and placebo were visually distinct from each other. The IMP was handled and administered by a qualified, unblinded HCP at the site who was not involved in the management of trial subjects and who did not perform any of the assessments. Maintenance treatment period was in parallel to the Open-label treatment period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Maintenance Treatment Period - Tralokinumab 300 mg Q2W
    Arm description
    Subjects initially randomised to tralokinumab 300 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 300 mg Q2W maintenance treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 300 mg Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Maintenance Treatment Period - Tralokinumab 300 mg Q4W
    Arm description
    Subjects initially randomised to tralokinumab 300 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 300 mg Q4W maintenance treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 300 mg Q4W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab or 2 subcutaneous injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Maintenance Treatment Period - Tralokinumab 150 mg Q2W
    Arm description
    Subjects initially randomised to tralokinumab 150 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 150 mg Q2W maintenance treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 150 mg Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo Q2W to receive a total dose of 150 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Maintenance Treatment Period - Tralokinumab 150 mg Q4W
    Arm description
    Subjects initially randomised to tralokinumab 150 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 150 mg Q4W maintenance treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumb 150 mg Q4W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 300 mg tralokinumab or 2 subcutaneous injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

    Arm title
    Maintenance Treatment Period - Placebo Q2W
    Arm description
    Subjects initially randomised to placebo, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-assigned to placebo maintenance treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At each visit, subject received 2 SC injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the SC tissue of the upper arm, anterior thigh, or abdomen, separated by at least 3 cm.

    Number of subjects in period 3 [2]
    Maintenance Treatment Period - Tralokinumab 300 mg Q2W Maintenance Treatment Period - Tralokinumab 300 mg Q4W Maintenance Treatment Period - Tralokinumab 150 mg Q2W Maintenance Treatment Period - Tralokinumab 150 mg Q4W Maintenance Treatment Period - Placebo Q2W
    Started
    13
    14
    12
    14
    6
    Completed
    5
    8
    8
    8
    4
    Not completed
    8
    6
    4
    6
    2
         Excluded from trial+FAS due to quality/GCP issues
    1
    -
    -
    -
    -
         Discontinued IMP before Week 52
    1
    1
    -
    1
    -
         Transferred to open-label treatment
    6
    5
    4
    5
    2
    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: The maintenance treatment period was in parallel to the open-label treatment period. Subjects from the initial treatment phase entered either into the maintenance treatment period or the open-label treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Initial treatment period - Tralokinumab 300 mg Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)

    Reporting group title
    Initial treatment period - Tralokinumab 150 mg Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)

    Reporting group title
    Initial treatment period - Placebo Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).

    Reporting group values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W Total
    Number of subjects
    101 100 100 301
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    101 100 100 301
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.6 ± 1.8 14.8 ± 1.7 14.4 ± 1.6 -
    Gender categorical
    Units: Subjects
        Female
    52 48 46 146
        Male
    49 52 54 155
    Race
    Units: Subjects
        White
    59 56 58 173
        Black or African American
    14 8 12 34
        Asian
    21 28 23 72
        American Indian or Alaska native
    0 2 1 3
        Native Hawaiian or other Pacific islander
    2 0 2 4
        Other
    5 6 4 15
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    12 10 10 32
        Not Hispanic or Latino
    89 90 90 269
        Unknown or Not Reported
    0 0 0 0
    Investigator's Global Assessment
    The Investigator's Global Assessment (IGA) is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    Units: Subjects
        Clear
    0 0 0 0
        Almost Clear
    0 0 0 0
        Mild
    0 0 0 0
        Moderate
    52 55 54 161
        Severe
    48 44 45 137
        Missing
    1 1 1 3
    Eczema Area and Severity Index
    Measure description: The Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    31.90 ± 13.74 31.89 ± 12.97 31.25 ± 14.19 -
    Scoring Atopic Dermatitis
    The Scoring Atopic Dermatitis (SCORAD) is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    68.41 ± 13.51 67.42 ± 14.51 67.70 ± 14.77 -
    Children's Dermatology Life Quality Index
    The Children's Dermatology Life Quality Index (CDLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor health-related quality of life.
    Units: units on a scale
        arithmetic mean (standard deviation)
    13.29 ± 7.18 12.86 ± 6.27 13.14 ± 5.99 -
    Adolescent Worst Pruritus NRS (weekly average)
    Subjects assessed their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Adolescent Worst Pruritus NRS') each morning, with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.79 ± 1.53 7.49 ± 1.58 7.45 ± 1.62 -
    Body surface area affected by atopic dermatitis (AD)
    Units: percentage affected
        arithmetic mean (standard deviation)
    49.8 ± 23.0 52.0 ± 22.5 50.9 ± 23.5 -
    Age of onset of atopic dermatitis (AD)
    Units: years
        arithmetic mean (standard deviation)
    2.5 ± 3.5 2.1 ± 3.3 2.4 ± 3.5 -
    Duration of atopic dermatitis (AD)
    Units: years
        arithmetic mean (standard deviation)
    12.1 ± 3.7 12.7 ± 3.7 12.0 ± 3.4 -

    End points

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    End points reporting groups
    Reporting group title
    Initial treatment period - Tralokinumab 300 mg Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)

    Reporting group title
    Initial treatment period - Tralokinumab 150 mg Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)

    Reporting group title
    Initial treatment period - Placebo Q2W
    Reporting group description
    Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).
    Reporting group title
    Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS
    Reporting group description
    Subjects in the open-label treatment period (Week 16 to Week 52) treated with tralokinumab every second week (Q2W) + optional TCS. Subjects transferred to open-label treatment at Week 16 if they did not achieve protocol-defined clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 OR after Week 16 if they lost clinical response during the maintenance treatment period. Loss of clinical response during the maintenance treatment period was defined as: -IGA of at least 2 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=0 at Week 16 -IGA of at least 3 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=1 at Week 16 -Not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA>1 at Week 1
    Reporting group title
    Maintenance Treatment Period - Tralokinumab 300 mg Q2W
    Reporting group description
    Subjects initially randomised to tralokinumab 300 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 300 mg Q2W maintenance treatment.

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 300 mg Q4W
    Reporting group description
    Subjects initially randomised to tralokinumab 300 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 300 mg Q4W maintenance treatment.

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 150 mg Q2W
    Reporting group description
    Subjects initially randomised to tralokinumab 150 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 150 mg Q2W maintenance treatment.

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 150 mg Q4W
    Reporting group description
    Subjects initially randomised to tralokinumab 150 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 150 mg Q4W maintenance treatment.

    Reporting group title
    Maintenance Treatment Period - Placebo Q2W
    Reporting group description
    Subjects initially randomised to placebo, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-assigned to placebo maintenance treatment.

    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
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    17
    21
    4
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.002 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    13.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.3
         upper limit
    22.3
    Notes
    [1] - Primary endpoint tested sequentially at a 5% significance level.
    [2] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    17.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.4
         upper limit
    26.6
    Notes
    [3] - Primary endpoint tested sequentially at a 5% significance level.
    [4] - Based on the primary analysis of the primary estimand 'composite'.

    Primary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

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    End point title
    Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    End point type
    Primary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    27
    28
    6
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    > 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12
         upper limit
    32
    Notes
    [5] - Primary endpoint tested sequentially at a 5% significance level.
    [6] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    22.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.4
         upper limit
    32.6
    Notes
    [7] - Primary endpoint tested sequentially at a 5% significance level.
    [8] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

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    End point title
    Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16
    End point description
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    96 [9]
    95 [10]
    90 [11]
    Units: Number of subjects with response
    24
    22
    3
    Notes
    [9] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.
    [10] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.
    [11] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    < 0.001 [13]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    21.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.3
         upper limit
    31.1
    Notes
    [12] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
    [13] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    P-value
    < 0.001 [15]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    19.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.6
         upper limit
    29.2
    Notes
    [14] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
    [15] - Based on the primary analysis of the primary estimand 'composite'.

    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
    The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    98
    97
    94
    Units: Adjusted mean change
        least squares mean (standard error)
    -29.1 ± 2.4
    -27.5 ± 2.4
    -9.5 ± 3.0
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    P-value
    < 0.001 [17]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -19.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -27.1
         upper limit
    -12.2
    Notes
    [16] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
    [17] - Based on the primary analysis of the primary estimand 'hypothetical'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    P-value
    < 0.001 [19]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.6
         upper limit
    -10.4
    Notes
    [18] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
    [19] - Based on the primary analysis of the primary estimand 'hypothetical'.

    Secondary: Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

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    End point title
    Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16
    End point description
    The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    94 [20]
    95 [21]
    89 [22]
    Units: Adjusted mean change
        least squares mean (standard error)
    -6.7 ± 0.6
    -6.1 ± 0.6
    -4.1 ± 0.7
    Notes
    [20] - Subjects in the full analysis set with non-missing baseline CDLQI score
    [21] - Subjects in the full analysis set with non-missing baseline CDLQI score
    [22] - Subjects in the full analysis set with non-missing baseline CDLQI score
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    superiority [23]
    P-value
    = 0.007 [24]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.5
         upper limit
    -0.7
    Notes
    [23] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
    [24] - Based on the primary analysis of the primary estimand 'hypothetical'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    superiority [25]
    P-value
    = 0.04 [26]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    -0.1
    Notes
    [25] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
    [26] - Based on the primary analysis of the primary estimand 'hypothetical'.

    Secondary: Number of Adverse Events

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    End point title
    Number of Adverse Events
    End point description
    Overall number of AEs during the Initial treatment period is presented. For a complete description of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of adverse events
    130
    175
    134
    No statistical analyses for this end point

    Secondary: Presence of Anti-drug Antibodies

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    End point title
    Presence of Anti-drug Antibodies
    End point description
    Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects
    1
    7
    2
    No statistical analyses for this end point

    Secondary: Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.

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    End point title
    Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    50
    45
    13
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [27]
    P-value
    < 0.001 [28]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    38.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    26.8
         upper limit
    50.2
    Notes
    [27] - The statistical test was not controlled for multiplicity.
    [28] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [29]
    P-value
    < 0.001 [30]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    32.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.6
         upper limit
    44.1
    Notes
    [29] - The statistical test was not controlled for multiplicity.
    [30] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.

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    End point title
    Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    17
    19
    4
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [31]
    P-value
    = 0.002 [32]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    13.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.2
         upper limit
    22.2
    Notes
    [31] - The statistical test was not controlled for multiplicity.
    [32] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [33]
    P-value
    < 0.001 [34]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    15.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.5
         upper limit
    24.1
    Notes
    [33] - The statistical test was not controlled for multiplicity.
    [34] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16

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    End point title
    Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Adjusted mean change
        least squares mean (standard error)
    -18.1 ± 1.3
    -18.1 ± 1.4
    -8.7 ± 1.6
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [35]
    P-value
    < 0.001 [36]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -9.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.5
         upper limit
    -5.3
    Notes
    [35] - The statistical test was not controlled for multiplicity.
    [36] - Based on the primary analysis of the primary estimand 'hypothetical'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [37]
    P-value
    < 0.001 [38]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -9.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.6
         upper limit
    -5.3
    Notes
    [37] - The statistical test was not controlled for multiplicity.
    [38] - Based on the primary analysis of the primary estimand 'hypothetical'.

    Secondary: Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16

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    End point title
    Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16
    End point description
    The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    12
    16
    1
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [39]
    P-value
    = 0.002 [40]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    11.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.5
         upper limit
    18.4
    Notes
    [39] - The statistical test was not controlled for multiplicity.
    [40] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [41]
    P-value
    < 0.001 [42]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    15.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.8
         upper limit
    23.3
    Notes
    [41] - The statistical test was not controlled for multiplicity.
    [42] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16

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    End point title
    Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16
    End point description
    The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    97
    98
    94
    Units: Number of subjects with response
    30
    30
    5
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [43]
    P-value
    < 0.001 [44]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    26.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.1
         upper limit
    36.3
    Notes
    [43] - The statistical test was not controlled for multiplicity.
    [44] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [45]
    P-value
    < 0.001 [46]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    25.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.3
         upper limit
    35.7
    Notes
    [45] - The statistical test was not controlled for multiplicity.
    [46] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16

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    End point title
    Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16
    End point description
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    96 [47]
    96 [48]
    92 [49]
    Units: Adjusted mean change
        least squares mean (standard error)
    -3.0 ± 0.3
    -2.7 ± 0.3
    -1.5 ± 0.3
    Notes
    [47] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.
    [48] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.
    [49] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority [50]
    P-value
    < 0.001 [51]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    -0.6
    Notes
    [50] - The statistical test was not controlled for multiplicity.
    [51] - Based on the primary analysis of the primary estimand 'hypothetical'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority [52]
    P-value
    = 0.007 [53]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    -0.3
    Notes
    [52] - The statistical test was not controlled for multiplicity.
    [53] - Based on the primary analysis of the primary estimand 'hypothetical'.

    Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16

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    End point title
    Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16
    End point description
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    96 [54]
    95 [55]
    91 [56]
    Units: Number of subjects with response
    28
    29
    8
    Notes
    [54] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.
    [55] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.
    [56] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    superiority [57]
    P-value
    < 0.001 [58]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    20.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.7
         upper limit
    31
    Notes
    [57] - The statistical test was not controlled for multiplicity.
    [58] - Based on the primary analysis of the primary estimand 'composite'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority [59]
    P-value
    < 0.001 [60]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    21.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.9
         upper limit
    32.7
    Notes
    [59] - The statistical test was not controlled for multiplicity.
    [60] - Based on the primary analysis of the primary estimand 'composite'.

    Secondary: Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16

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    End point title
    Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16
    End point description
    The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
    End point type
    Secondary
    End point timeframe
    From Week 0 to Week 16
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W Initial treatment period - Placebo Q2W
    Number of subjects analysed
    94 [61]
    95 [62]
    87 [63]
    Units: Adjusted mean change
        least squares mean (standard error)
    -8.4 ± 0.8
    -7.8 ± 0.8
    -2.4 ± 1.0
    Notes
    [61] - Subjects in the full analysis set with non-missing baseline POEM score.
    [62] - Subjects in the full analysis set with non-missing baseline POEM score.
    [63] - Subjects in the full analysis set with non-missing baseline POEM score.
    Statistical analysis title
    Tralokinumab 300 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority [64]
    P-value
    < 0.001 [65]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.4
         upper limit
    -3.6
    Notes
    [64] - The statistical test was not controlled for multiplicity.
    [65] - ents Based on the primary analysis of the primary estimand 'hypothetical'.
    Statistical analysis title
    Tralokinumab 150 mg Q2W versus Placebo
    Statistical analysis description
    Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.
    Comparison groups
    Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority [66]
    P-value
    < 0.001 [67]
    Method
    Repeated measurements model
    Parameter type
    Difference of least square means
    Point estimate
    -5.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.9
         upper limit
    -3
    Notes
    [66] - The statistical test was not controlled for multiplicity.
    [67] - Based on the primary analysis of the primary estimand 'hypothetical'.

    Secondary: Tralokinumab Serum Trough Concentration at Week 16

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    End point title
    Tralokinumab Serum Trough Concentration at Week 16 [68]
    End point description
    Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
    End point type
    Secondary
    End point timeframe
    At Week 16
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Tralokinumab serum trough concentration was not analysed for subjects who were not randomised to tralokinumab.
    End point values
    Initial treatment period - Tralokinumab 300 mg Q2W Initial treatment period - Tralokinumab 150 mg Q2W
    Number of subjects analysed
    89
    87
    Units: microgram/mL
        geometric mean (geometric coefficient of variation)
    129.1 ± 39.0
    69.0 ± 35.4
    No statistical analyses for this end point

    Secondary: Subjects With Investigator’s Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to 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 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
    End point description
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Maintenance Treatment Period - Tralokinumab 300 mg Q2W Maintenance Treatment Period - Tralokinumab 300 mg Q4W Maintenance Treatment Period - Tralokinumab 150 mg Q2W Maintenance Treatment Period - Tralokinumab 150 mg Q4W
    Number of subjects analysed
    11
    13
    12
    14
    Units: Number of subjects with response
    4
    7
    6
    7
    No statistical analyses for this end point

    Secondary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

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    End point title
    Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Maintenance Treatment Period - Tralokinumab 300 mg Q2W Maintenance Treatment Period - Tralokinumab 300 mg Q4W Maintenance Treatment Period - Tralokinumab 150 mg Q2W Maintenance Treatment Period - Tralokinumab 150 mg Q4W
    Number of subjects analysed
    11
    13
    12
    14
    Units: Number of subjects with response
    5
    7
    7
    7
    No statistical analyses for this end point

    Secondary: Tralokinumab Serum Trough Concentration at Week 66

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    End point title
    Tralokinumab Serum Trough Concentration at Week 66
    End point description
    Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
    End point type
    Secondary
    End point timeframe
    At Week 66
    End point values
    Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS Maintenance Treatment Period - Tralokinumab 300 mg Q2W Maintenance Treatment Period - Tralokinumab 300 mg Q4W Maintenance Treatment Period - Tralokinumab 150 mg Q2W Maintenance Treatment Period - Tralokinumab 150 mg Q4W
    Number of subjects analysed
    119
    1
    5
    4
    3
    Units: microgram/mL
        geometric mean (geometric coefficient of variation)
    8.27 ± 9.49
    7.26 ± 0
    2.40 ± 1.76
    3.02 ± 3.27
    3.60 ± 2.12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    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 300 Q2W
    Reporting group description
    -

    Reporting group title
    Initial Treatment Period - Tralokinumab 150 Q2W
    Reporting group description
    -

    Reporting group title
    Initial Treatment Period - Placebo
    Reporting group description
    -

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 300 Q2W
    Reporting group description
    -

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 300 Q4W
    Reporting group description
    -

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 150 Q2W
    Reporting group description
    -

    Reporting group title
    Maintenance Treatment Period - Tralokinumab 150 Q4W
    Reporting group description
    -

    Reporting group title
    Maintenance Treatment Period - Placebo
    Reporting group description
    -

    Reporting group title
    Open-label Treatment - Tralokinumab 300 Q2W + optional TCS
    Reporting group description
    -

    Reporting group title
    Safety Follow-up
    Reporting group description
    -

    Serious adverse events
    Initial Treatment Period - Tralokinumab 300 Q2W Initial Treatment Period - Tralokinumab 150 Q2W Initial Treatment Period - Placebo Maintenance Treatment Period - Tralokinumab 300 Q2W Maintenance Treatment Period - Tralokinumab 300 Q4W Maintenance Treatment Period - Tralokinumab 150 Q2W Maintenance Treatment Period - Tralokinumab 150 Q4W Maintenance Treatment Period - Placebo Open-label Treatment - Tralokinumab 300 Q2W + optional TCS Safety Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    3 / 98 (3.06%)
    5 / 94 (5.32%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    7 / 234 (2.99%)
    3 / 234 (1.28%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    Psychiatric disorders
    Anorexia nervosa
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal injury
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Initial Treatment Period - Tralokinumab 300 Q2W Initial Treatment Period - Tralokinumab 150 Q2W Initial Treatment Period - Placebo Maintenance Treatment Period - Tralokinumab 300 Q2W Maintenance Treatment Period - Tralokinumab 300 Q4W Maintenance Treatment Period - Tralokinumab 150 Q2W Maintenance Treatment Period - Tralokinumab 150 Q4W Maintenance Treatment Period - Placebo Open-label Treatment - Tralokinumab 300 Q2W + optional TCS Safety Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 97 (45.36%)
    47 / 98 (47.96%)
    36 / 94 (38.30%)
    7 / 11 (63.64%)
    6 / 13 (46.15%)
    7 / 12 (58.33%)
    8 / 14 (57.14%)
    4 / 6 (66.67%)
    100 / 234 (42.74%)
    16 / 234 (6.84%)
    Injury, poisoning and procedural complications
    Inappropriate schedule of drug administration
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 234 (0.85%)
    0 / 234 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    2
    0
    Procedural anxiety
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Wrong drug administered
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 97 (4.12%)
    1 / 98 (1.02%)
    3 / 94 (3.19%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    4 / 234 (1.71%)
    0 / 234 (0.00%)
         occurrences all number
    4
    2
    3
    0
    1
    0
    1
    0
    4
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 234 (0.85%)
    0 / 234 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 97 (6.19%)
    5 / 98 (5.10%)
    3 / 94 (3.19%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    12 / 234 (5.13%)
    0 / 234 (0.00%)
         occurrences all number
    6
    5
    3
    0
    0
    0
    0
    0
    17
    0
    Migraine
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    2 / 234 (0.85%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    2
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 97 (2.06%)
    2 / 98 (2.04%)
    2 / 94 (2.13%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    4 / 234 (1.71%)
    0 / 234 (0.00%)
         occurrences all number
    2
    2
    3
    0
    0
    1
    1
    0
    4
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 97 (0.00%)
    4 / 98 (4.08%)
    4 / 94 (4.26%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    4
    4
    1
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    2 / 97 (2.06%)
    6 / 98 (6.12%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    10 / 234 (4.27%)
    0 / 234 (0.00%)
         occurrences all number
    3
    9
    0
    0
    1
    0
    0
    0
    16
    0
    Malaise
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 234 (0.85%)
    0 / 234 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    6
    0
    0
    12
    0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 97 (3.09%)
    0 / 98 (0.00%)
    4 / 94 (4.26%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    3 / 234 (1.28%)
    1 / 234 (0.43%)
         occurrences all number
    3
    0
    4
    0
    0
    1
    1
    0
    3
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    7 / 97 (7.22%)
    12 / 98 (12.24%)
    11 / 94 (11.70%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    1 / 6 (16.67%)
    19 / 234 (8.12%)
    8 / 234 (3.42%)
         occurrences all number
    7
    16
    15
    0
    0
    1
    2
    1
    26
    9
    Dermatitis contact
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 98 (2.04%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    4 / 234 (1.71%)
    2 / 234 (0.85%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    6
    2
    Furuncle
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 234 (0.43%)
    0 / 234 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 94 (0.00%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 234 (0.00%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    2 / 97 (2.06%)
    2 / 98 (2.04%)
    1 / 94 (1.06%)
    2 / 11 (18.18%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    3 / 234 (1.28%)
    2 / 234 (0.85%)
         occurrences all number
    2
    2
    1
    2
    0
    0
    0
    0
    3
    2
    Oral herpes
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 94 (1.06%)
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    6 / 234 (2.56%)
    0 / 234 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    7
    0
    Pharyngitis
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 98 (2.04%)
    4 / 94 (4.26%)
    0 / 11 (0.00%)
    0 / 13 (0.00%)
    3 / 12 (25.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    6 / 234 (2.56%)
    1 / 234 (0.43%)
         occurrences all number
    0
    2
    4
    0
    0
    4
    0
    0
    6
    1
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 97 (11.34%)
    8 / 98 (8.16%)
    4 / 94 (4.26%)
    2 / 11 (18.18%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    25 / 234 (10.68%)
    3 / 234 (1.28%)
         occurrences all number
    11
    10
    5
    2
    0
    2
    1
    0
    34
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    12 / 97 (12.37%)
    19 / 98 (19.39%)
    8 / 94 (8.51%)
    2 / 11 (18.18%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    44 / 234 (18.80%)
    1 / 234 (0.43%)
         occurrences all number
    16
    22
    10
    2
    1
    2
    1
    0
    60
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2018
    The main reason for this amendment was extension of the post-IMP observation period at the first 3 visits in the initial treatment period and in the in open label treatment period from 30 minutes to 2 hours.
    06 Feb 2020
    The main reason for this amendment was introduction of the possibility for eligible subjects in selected countries to continue in a long-term extension trial (ECZTEND). Subjects could enter ECZTEND from completion of the treatment period and up to 26 weeks from their last IMP injection in the present trial to the first IMP injection in ECZTEND.

    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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