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    Clinical Trial Results:
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB WHEN USED IN COMBINATION WITH TOPICAL CORTICOSTEROID TREATMENT IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

    Summary
    EudraCT number
    		 2019-004300-34
    Trial protocol
    		 PL  
    Global end of trial date
    16 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2022
    First version publication date
    20 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    J2T-DM-KGAD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04250337
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17803
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002536-PIP01-18
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2020
    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
    Canada: 22
    Country: Number of subjects enrolled
    United States: 168
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Germany: 11
    Worldwide total number of subjects
    228
    EEA total number of subjects
    38
    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)
    53
    Adults (18-64 years)
    155
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A participant is considered to have completed the study if he/she has completed the last scheduled visit: Participants continuing into Long-term Extension (LTE), upon completion of week 16 visit and rolling into LTE study. Participants not continuing into LTE, when participant had either week 16 or ET visit, and safety follow up visit.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Topical Corticosteroid
    Arm description
    		 Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14.

    Arm title
    		 Lebrikizumab + Topical Corticosteroid
    Arm description
    		 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg of Lebrikizumab Q2W from Week 4 until Week 14.

    Number of subjects in period 1
    		Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Started
    75
    153
    Received at Least One Dose of Study Drug
    75
    153
    Completed
    67
    142
    Not completed
    8
    11
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    3
         Lack of efficacy
    1
    3
         Protocol deviation
    2
    2
         Withdrawal by subject
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Topical Corticosteroid
    Reporting group description
    		 Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response

    Reporting group title
    Lebrikizumab + Topical Corticosteroid
    Reporting group description
    		 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.

    Reporting group values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid Total
    Number of subjects
    		 75 153 228
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 18 35 53
        Adults (18-64 years)
    		 52 103 155
        From 65-84 years
    		 5 15 20
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 37 75 112
        Male
    		 38 78 116
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 5 7
        Asian
    		 13 18 31
        Native Hawaiian or Other Pacific Islander
    		 0 3 3
        Black or African American
    		 9 21 30
        White
    		 49 96 145
        More than one race
    		 1 8 9
        Unknown or Not Reported
    		 1 2 3
    Region of Enrollment
    Units: Subjects
        Canada
    		 8 14 22
        United States
    		 57 111 168
        Poland
    		 8 19 27
        Germany
    		 2 9 11

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Topical Corticosteroid
    Reporting group description
    		 Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response

    Reporting group title
    Lebrikizumab + Topical Corticosteroid
    Reporting group description
    		 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.

    Primary: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16

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    End point title
    		 Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Analysis Population Description: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to Good Clinical Practice (GCP) issues.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66
    145
    Units: percentage of participants
        number (confidence interval 95%)
    22.1 (11.6 to 32.7)
    41.2 (33.0 to 49.4)
    Statistical analysis title
    		 IGA Score Reduction ≥2-points
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    18.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1
         upper limit
    		 31.5

    Primary: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI score) at Week 16

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    End point title
    		 Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI score) at Week 16
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. APD: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66 [1]
    145 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    42.2 (30.1 to 54.4)
    69.5 (61.9 to 77.2)
    Notes
    [1] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [2] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 EASI-75
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    26.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 40.8

    Secondary: Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16

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    End point title
    		 Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). APD: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66 [3]
    145 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    21.7 (11.4 to 32.0)
    41.2 (33.0 to 49.3)
    Notes
    [3] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [4] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 EASI-90
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.1
         upper limit
    		 31.7

    Secondary: Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

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    End point title
    		 Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
    End point description
    Pruritus NRS is an 11-point scale used by patients to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors. APD: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    63
    139
    Units: Percent change
        least squares mean (standard error)
    -35.47 ± 6.358
    -50.68 ± 4.546
    Statistical analysis title
    		 Percent Change Pruritus NRS
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017263
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -15.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.7
         upper limit
    		 -2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.373

    Secondary: Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16
    End point description
    Pruritus NRS is an 11-point scale used by patients to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    57
    130
    Units: percentage of participants
        number (confidence interval 95%)
    31.9 (19.3 to 44.4)
    50.6 (41.8 to 59.4)
    Statistical analysis title
    		 Pruritus NRS ≥4-Point Reduction
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    19.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.3
         upper limit
    		 34.1

    Secondary: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16
    End point description
    Pruritus NRS is an 11-point scale used by patients to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53
    124
    Units: percentage of participants
        number (confidence interval 95%)
    26.4 (14.5 to 38.3)
    46.8 (38.0 to 55.6)
    Statistical analysis title
    		 Pruritus NRS of ≥5-points
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    21.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.1
         upper limit
    		 36.1

    Secondary: Percent Change in EASI Score From Baseline at Week 16

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    End point title
    		 Percent Change in EASI Score From Baseline at Week 16
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors. APD: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66 [5]
    145 [6]
    Units: percent change
        least squares mean (standard error)
    -53.12 ± 5.097
    -76.76 ± 4.119
    Notes
    [5] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [6] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Percent Change in EASI Score
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.000003
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -23.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.6
         upper limit
    		 -13.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.119

    Secondary: Change From Baseline to Week 16 in Percent Body Surface Area (BSA)

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    End point title
    		 Change From Baseline to Week 16 in Percent Body Surface Area (BSA)
    End point description
    The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53 [7]
    130 [8]
    Units: score on a scale
        least squares mean (standard error)
    -16.92 ± 2.287
    -29.19 ± 1.686
    Notes
    [7] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [8] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Change from Baseline BSA
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -12.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.07
         upper limit
    		 -7.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.428

    Secondary: Percentage of Participants Achieving EASI-90 at Week 4

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    End point title
    		 Percentage of Participants Achieving EASI-90 at Week 4
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66 [9]
    145 [10]
    Units: percentage of participants
        number (confidence interval 95%)
    7.2 (0.5 to 13.8)
    10.7 (5.6 to 15.8)
    Notes
    [9] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [10] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 EASI-90 at Week 4
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.454
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 11.8

    Secondary: Percent Change in Sleep-loss Score From Baseline to Week 16

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    End point title
    		 Percent Change in Sleep-loss Score From Baseline to Week 16
    End point description
    Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    62
    134
    Units: percent change
        least squares mean (standard error)
    -36.89 ± 12.217
    -57.03 ± 7.939
    Statistical analysis title
    		 Percent Change from Baseline Sleep-loss
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.117607
    Method
    		 ANCOVA
    Parameter type
    		 Markov Chain Monte Carlo (MCMC)
    Point estimate
    -20.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.4
         upper limit
    		 5.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.81

    Secondary: Change From Baseline in Sleep-loss Score at Week 16

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    End point title
    		 Change From Baseline in Sleep-loss Score at Week 16
    End point description
    Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    63
    139
    Units: score on a scale
        least squares mean (standard error)
    -0.80 ± 0.132
    -1.10 ± 0.102
    Statistical analysis title
    		 Change from Baseline Sleep Loss
    Comparison groups
    Lebrikizumab + Topical Corticosteroid v Placebo + Topical Corticosteroid
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025293
    Method
    		 ANCOVA
    Parameter type
    		 Markov Chain Monte Carlo (MCMC)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.134

    Secondary: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    57
    130
    Units: percentage of participants
        number (confidence interval 95%)
    9.3 (1.6 to 17.1)
    23.5 (16.2 to 30.9)
    Statistical analysis title
    		 Pruritus NRS of ≥4-point Reduction Week 4
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    14.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 24.7

    Secondary: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    57
    130
    Units: percentage of participants
        number (confidence interval 95%)
    7.1 (0.4 to 13.8)
    8.5 (3.7 to 13.3)
    Statistical analysis title
    		 Pruritus NRS ≥4-points Reduction Week 2
    Comparison groups
    Lebrikizumab + Topical Corticosteroid v Placebo + Topical Corticosteroid
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.764
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.7

    Secondary: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 1
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    57
    130
    Units: percentage of participants
        number (confidence interval 95%)
    1.8 (0.0 to 5.2)
    3.8 (0.5 to 7.2)
    Statistical analysis title
    		 Pruritus NRS ≥4-point Reduction Week 1
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.498
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 6.7

    Secondary: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53
    124
    Units: percentage of participants
        number (confidence interval 95%)
    7.5 (0.4 to 14.7)
    23.4 (15.9 to 30.8)
    Statistical analysis title
    		 Pruritus NRS of ≥5-points Week 4
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.3
         upper limit
    		 25.9

    Secondary: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53
    124
    Units: percentage of participants
        number (confidence interval 95%)
    7.5 (0.4 to 14.7)
    8.9 (3.9 to 13.9)
    Statistical analysis title
    		 Pruritus NRS of ≥5-points Week 2
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.818
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 10.2

    Secondary: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

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    End point title
    		 Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
    End point description
    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. APD: All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 1
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53
    124
    Units: percentage of participants
        number (confidence interval 95%)
    1.9 (0.0 to 5.5)
    4.0 (0.6 to 7.5)
    Statistical analysis title
    		 Pruritus NRS of ≥5-points Week 1
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.499
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 7.1

    Secondary: Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16

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    End point title
    		 Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16
    End point description
    Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    53
    131
    Units: percentage of days
        least squares mean (standard error)
    23.88 ± 4.823
    31.17 ± 3.512
    Statistical analysis title
    		 TCS/TCI Free Days
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.155
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    7.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 17.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.104

    Secondary: Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16

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    End point title
    		 Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16
    End point description
    Days from first study drug injection to the day patient stop using all TCS/TCI (if a patient start and stop using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this patient). All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    66 [11]
    145
    Units: days
        median (full range (min-max))
    9999 (9999 to 9999)
    121.0 (2 to 121)
    Notes
    [11] - Less than 50 % of participants reached TCS free within treatment window, median was not calculable.
    No statistical analyses for this end point

    Secondary: Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

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    End point title
    		 Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
    End point description
    The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing Values were imputed using last observation carried forward (LOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    65 [12]
    140 [13]
    Units: percent change
        least squares mean (standard error)
    -37.35 ± 4.415
    -55.04 ± 3.542
    Notes
    [12] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [13] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Percent Change in SCORAD
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -17.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.37
         upper limit
    		 -9.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.403

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 LS Means was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    51 [14]
    109 [15]
    Units: score on a scale
        least squares mean (standard error)
    -6.46 ± 1.855
    -9.79 ± 1.815
    Notes
    [14] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [15] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Change From Baseline DLQI
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001031
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -3.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.014

    Secondary: Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points

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    End point title
    		 Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points
    End point description
    The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 LS Means was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    48 [16]
    105 [17]
    Units: percentage of participants
        number (confidence interval 95%)
    58.7 (44.1 to 73.2)
    77.4 (69.3 to 85.5)
    Notes
    [16] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [17] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 DLQI Score ≥4 Points
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 34.3
    Variability estimate
    Standard error of the mean

    Secondary: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16

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    End point title
    		 Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16
    End point description
    The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. Missing values were imputed using LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    65 [18]
    143 [19]
    Units: score on a scale
    least squares mean (standard error)
        Health State Index UK
    0.05 ± 0.025
    0.15 ± 0.019
        Health State Index US
    0.03 ± 0.018
    0.10 ± 0.014
    Notes
    [18] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [19] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Health State Index UK
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Statistical analysis title
    		 Health State Index US
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.018

    Secondary: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16

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    End point title
    		 Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16
    End point description
    The EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    65
    143
    Units: millimeters (mm)
        least squares mean (standard error)
    6.51 ± 2.364
    10.13 ± 1.831
    Statistical analysis title
    		 EQ-5D-5L VAS
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.131
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 8.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.386

    Secondary: Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

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    End point title
    		 Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
    End point description
    POEM is a 7-item, validated, questionnaire used by the patient to assess disease symptoms over the last week. The patient is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1‒ 2 days = 1; 3-4 days = 2; 5‒6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    40 [20]
    101 [21]
    Units: score on a scale
        least squares mean (standard error)
    -6.24 ± 1.038
    -10.23 ± 0.727
    Notes
    [20] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [21] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Change From Baseline POEM
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.26
         upper limit
    		 -1.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.145

    Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults

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    End point title
    		 Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults
    End point description
    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores; higher scores indicated greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized patients, even if the patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    43
    101
    Units: score on a scale
        least squares mean (standard error)
    -1.08 ± 1.367
    -1.88 ± 1.027
    Statistical analysis title
    		 Anxiety
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.571
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.58
         upper limit
    		 1.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.407

    Secondary: Change From Baseline in PROMIS Depression at Week 16 - Adults

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    End point title
    		 Change From Baseline in PROMIS Depression at Week 16 - Adults
    End point description
    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Higher score indicates greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    43
    101
    Units: score on a scale
        least squares mean (standard error)
    -1.21 ± 1.098
    -1.38 ± 0.834
    Statistical analysis title
    		 Depression
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.882
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.127

    Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma

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    End point title
    		 Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
    End point description
    The ACQ-5 has been shown to reliably measure asthma control and distinguish patients with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    14 [22]
    38 [23]
    Units: score on a scale
        least squares mean (standard error)
    0.12 ± 0.116
    0.13 ± 0.076
    Notes
    [22] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [23] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Change From Baseline ACQ-5
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.922
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.116

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

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    End point title
    		 Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) at Week 16
    End point description
    The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    11 [24]
    24 [25]
    Units: score on a scale
        least squares mean (standard error)
    -4.71 ± 1.170
    -9.33 ± 0.887
    Notes
    [24] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    [25] - One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    Statistical analysis title
    		 Change From Baseline CDLQI
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -4.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.22
         upper limit
    		 -2.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.271

    Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics

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    End point title
    		 Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics
    End point description
    ROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores; higher scores indicated greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    13
    31
    Units: score on a scale
        least squares mean (standard error)
    -4.92 ± 2.333
    -1.46 ± 1.732
    Statistical analysis title
    		 Anxiety
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.171
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 8.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.48

    Secondary: Change From Baseline in PROMIS Depression at Week 16 - Pediatrics

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    End point title
    		 Change From Baseline in PROMIS Depression at Week 16 - Pediatrics
    End point description
    PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 - 5. Total raw scores were converted to T-scores; higher scores indicated greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo + Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Number of subjects analysed
    13
    31
    Units: score on a scale
        least squares mean (standard error)
    -6.43 ± 2.536
    -2.01 ± 1.916
    Statistical analysis title
    		 Depression
    Comparison groups
    Placebo + Topical Corticosteroid v Lebrikizumab + Topical Corticosteroid
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.109
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    4.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 9.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.697

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 28
    Adverse event reporting additional description
    All randomized patients who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo +Topical Corticosteroid
    Reporting group description
    		 Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.

    Reporting group title
    Lebrikizumab + Topical Corticosteroid
    Reporting group description
    		 500 milligram (mg) Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14.

    Serious adverse events
    		 Placebo +Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 153 (1.31%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    sinus node dysfunction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo +Topical Corticosteroid Lebrikizumab + Topical Corticosteroid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 75 (34.67%)
    66 / 153 (43.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    keratoacanthoma
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    4 / 153 (2.61%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    injection site erythema
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    injection site pruritus
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    2
    injection site rash
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    injection site reaction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 153 (1.31%)
         occurrences all number
    1
    2
    injection site swelling
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    vaccination site pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    drug hypersensitivity
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    rhinitis allergic
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    sinus congestion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Psychiatric disorders
    attention deficit hyperactivity disorder
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    insomnia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    blood pressure increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    2
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    weight increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    concussion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    corneal abrasion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    fall
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    fibula fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    ligament sprain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    muscle strain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    suture related complication
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    vaccination complication
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Nervous system disorders
    cervical radiculopathy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    dizziness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    headache
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    7 / 153 (4.58%)
         occurrences all number
    1
    7
    ophthalmic migraine
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    syncope
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    eosinophilia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    iron deficiency anaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    lymphadenopathy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    lymphocytosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    neutropenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    thrombocytopenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Eye disorders
    blepharitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    conjunctival haemorrhage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    dry eye
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    3 / 153 (1.96%)
         occurrences all number
    0
    3
    eye irritation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    2
    lacrimation increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    vernal keratoconjunctivitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    xerophthalmia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    flatulence
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    gastrointestinal inflammation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    nausea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    vomiting
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    hepatic steatosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    hepatomegaly
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    alopecia areata
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    dermatitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    dermatitis acneiform
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    dermatitis atopic
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 75 (4.00%)
    3 / 153 (1.96%)
         occurrences all number
    3
    3
    dermatitis contact
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    eczema
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    hyperhidrosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    skin lesion inflammation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    urticaria
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    bursitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    myalgia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    spinal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    bacterial colitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    covid-19
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    cellulitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 153 (0.65%)
         occurrences all number
    1
    1
    conjunctivitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    7 / 153 (4.58%)
         occurrences all number
    0
    8
    furuncle
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    impetigo
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 153 (1.31%)
         occurrences all number
    1
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    5 / 75 (6.67%)
    3 / 153 (1.96%)
         occurrences all number
    6
    5
    ophthalmic herpes simplex
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 153 (1.31%)
         occurrences all number
    1
    2
    tonsillitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    tooth abscess
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    tooth infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 153 (0.65%)
         occurrences all number
    2
    1
    urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    3 / 153 (1.96%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    alcohol intolerance
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    2
    hypercholesterolaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 153 (0.00%)
         occurrences all number
    1
    0
    hyperkalaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    hypokalaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    malnutrition
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 153 (1.31%)
         occurrences all number
    0
    2
    vitamin d deficiency
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 153 (0.65%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2020
    Revised to align with FDA and EU received recommendations and regulations, to add more clarifications and ensuring consistencies between different sections, and to be consistent across the Phase 3 studies of Lebrikizumab in atopic dermatitis. It is also important to mention there was no new safety finding/signals across the program.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Mar 2020
    Enrollment pause due to COVID-19.
    18 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    One investigational site with seventeen participants was excluded from analysis due to GCP issues.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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