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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

    Summary
    EudraCT number
    2014-000049-56
    Trial protocol
    DE   CZ   ES   FI   NL   PL  
    Global end of trial date
    18 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    04 May 2017
    First version publication date
    04 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS29250
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02340234
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the safety and efficacy of lebrikizumab used as adjunctive therapy with topical corticosteroids (TCS), compared with TCS in participants with persistent moderate to severe atopic dermatitis (AD).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice (GCP) according to the regulations and procedures described in the protocol. Approval from the Ethics Committee (EC)/Institutional Review Board (IRB) was obtained before study start. Roche also obtained approval from the relevant Competent Authority prior to starting the study. No modifications were made to the protocol after receipt of the EC/IRB approval.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Taiwan: 14
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Finland: 11
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Switzerland: 6
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    212
    EEA total number of subjects
    105
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    209
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 294 participants were screened, 212 participants were randomized, and 209 received at least one dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Lebrikizumab 250 mg Single Dose + TCS
    Arm description
    Participants received a single dose of lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1 percent [%] or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lebrikizumab administered as SC injection as per the schedule specified in the respective arms.

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Triamcinolone acetonide 0.1% cream was applied twice daily to active skin lesions.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to lebrikizumab

    Investigational medicinal product name
    Hydrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Hydrocortisone 2.5% cream was applied twice daily to active skin lesions.

    Arm title
    Lebrikizumab 125 mg Single Dose + TCS
    Arm description
    Participants received a single dose of lebrikizumab 125 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lebrikizumab administered as SC injection as per the schedule specified in the respective arms.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to lebrikizumab

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Triamcinolone acetonide 0.1% cream was applied twice daily to active skin lesions.

    Investigational medicinal product name
    Hydrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Hydrocortisone 2.5% cream was applied twice daily to active skin lesions.

    Arm title
    Lebrikizumab 125 mg Q4W + TCS
    Arm description
    Participants received lebrikizumab 125 mg SC injection every 4 weeks (Q4W) for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Lebrikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lebrikizumab administered as SC injection as per the schedule specified in the respective arms.

    Investigational medicinal product name
    Hydrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Hydrocortisone 2.5% cream was applied twice daily to active skin lesions.

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Triamcinolone acetonide 0.1% cream was applied twice daily to active skin lesions.

    Arm title
    Placebo Q4W + TCS Cream
    Arm description
    Participants received placebo Q4W for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to lebrikizumab

    Investigational medicinal product name
    Hydrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Hydrocortisone 2.5% cream was applied twice daily to active skin lesions.

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Triamcinolone acetonide 0.1% cream was applied twice daily to active skin lesions.

    Number of subjects in period 1
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Started
    53
    53
    52
    54
    Treated
    53
    52
    51
    53
    Completed
    53
    49
    48
    47
    Not completed
    0
    4
    4
    7
         Lack of efficacy
    -
    -
    1
    -
         Consent withdrawn by subject
    -
    2
    1
    3
         Other unspecified
    -
    1
    1
    -
         Adverse Event
    -
    -
    1
    1
         Lost to follow-up
    -
    1
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lebrikizumab 250 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1 percent [%] or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 125 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Q4W + TCS
    Reporting group description
    Participants received lebrikizumab 125 mg SC injection every 4 weeks (Q4W) for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Placebo Q4W + TCS Cream
    Reporting group description
    Participants received placebo Q4W for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream Total
    Number of subjects
    53 53 52 54 212
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    34.4 ± 12.3 34.9 ± 12.6 36.8 ± 12.2 38.8 ± 13.1 -
    Gender Categorical
    Units: Subjects
        Female
    22 18 16 18 74
        Male
    31 35 36 36 138

    End points

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    End points reporting groups
    Reporting group title
    Lebrikizumab 250 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1 percent [%] or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 125 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Q4W + TCS
    Reporting group description
    Participants received lebrikizumab 125 mg SC injection every 4 weeks (Q4W) for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Placebo Q4W + TCS Cream
    Reporting group description
    Participants received placebo Q4W for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Subject analysis set title
    Lebrikizumab 250 mg Single Dose + TCS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a single dose of lebrikizumab 250 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Subject analysis set title
    Lebrikizumab 125 mg Single Dose + TCS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a single dose of lebrikizumab 125 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Subject analysis set title
    Lebrikizumab 125 mg Q4W + TCS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received lebrikizumab 125 mg SC injection every 4 weeks (Q4W) for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Subject analysis set title
    Placebo Q4W + TCS Cream
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo Q4W for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Primary: Percentage of Participants Who Achieved a 50 Percent (%) Reduction From Baseline in EASI Score (EASI-50) at Week 12

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    End point title
    Percentage of Participants Who Achieved a 50 Percent (%) Reduction From Baseline in EASI Score (EASI-50) at Week 12
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 %-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    69.8 (57.45 to 82.17)
    69.2 (56.69 to 81.78)
    82.4 (71.89 to 92.82)
    62.3 (49.21 to 75.31)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% confidence interval (CI) was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4361
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    7.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.43
         upper limit
    25.52
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4792
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    6.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.13
         upper limit
    25.07
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0261
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    20.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.36
         upper limit
    36.81

    Secondary: Percent Change From Baseline in EASI Score at Week 12

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    End point title
    Percent Change From Baseline in EASI Score at Week 12
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (> 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population. Here, number of subjects analysed (N)=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: percent change
        least squares mean (standard error)
    -57.7 ± 5.263
    -58.46 ± 5.364
    -70.5 ± 5.452
    -53.14 ± 5.382
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and standard error of mean (SE) was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5458
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -4.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.41
         upper limit
    10.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.533
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4844
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -5.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.29
         upper limit
    9.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.594
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0247
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -17.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.48
         upper limit
    -2.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.671

    Secondary: Absolute Change From Baseline in EASI Score at Week 12

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    End point title
    Absolute Change From Baseline in EASI Score at Week 12
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (> 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: units on scale
        least squares mean (standard error)
    -15.63 ± 1.343
    -14.68 ± 1.367
    -17.73 ± 1.39
    -12.67 ± 1.372
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1256
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -2.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.75
         upper limit
    0.83
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.922
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3022
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.82
         upper limit
    1.81
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.936
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0105
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -5.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.91
         upper limit
    -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.956

    Secondary: Percentage of Participants Who Achieved a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12

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    End point title
    Percentage of Participants Who Achieved a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (> 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    49.1 (35.6 to 62.52)
    38.5 (25.24 to 51.68)
    54.9 (41.25 to 68.56)
    34 (21.21 to 46.71)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region. 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.123
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    15.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.44
         upper limit
    33.63
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region. 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6627
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.87
         upper limit
    22.87
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region. 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.036
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    20.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.26
         upper limit
    39.62

    Secondary: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 12

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    End point title
    Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 12
    End point description
    The IGA score is an assessment of the participant's disease state at the time of examination and does not attempt a comparison with any of the participant's previous disease states. The IGA utilizes a 6-point scale ranging from 0 to 5 where 0 = clear (no inflammatory signs of AD), 1 = almost clear (just perceptible erythema and papulation induration), 2 = mild (mild erythema and papulation induration; no oozing or crusting), 3 = moderate (moderate erythema and papulation induration; oozing and crusting may be present), 4 = severe (severe erythema and papulation induration; oozing and crusting is present) and 5 = very severe AD. mITT population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    28.3 (16.17 to 40.43)
    21.2 (10.05 to 32.25)
    33.3 (20.4 to 46.27)
    18.9 (8.33 to 29.4)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.263
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    9.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.63
         upper limit
    25.5
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7745
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    2.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.02
         upper limit
    17.59
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0976
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    14.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.22
         upper limit
    31.15

    Secondary: Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12

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    End point title
    Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
    End point description
    The IGA score is an assessment of the participant's disease state at the time of examination and does not attempt a comparison with any of the participant's previous disease states. The IGA utilizes a 6-point scale ranging from 0 to 5 where 0 = clear (no inflammatory signs of AD), 1 = almost clear (just perceptible erythema and papulation induration), 2 = mild (mild erythema and papulation induration; no oozing or crusting), 3 = moderate (moderate erythema and papulation induration; oozing and crusting may be present), 4 = severe (severe erythema and papulation induration; oozing and crusting is present) and 5 = very severe AD. mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    35.8 (22.94 to 48.76)
    23.1 (11.63 to 34.53)
    37.3 (23.99 to 50.52)
    24.5 (12.94 to 36.11)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2154
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    11.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.02
         upper limit
    28.67
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8603
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -1.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.74
         upper limit
    14.84
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1673
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    12.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.89
         upper limit
    30.34

    Secondary: Absolute Change From Baseline in IGA at Week 12

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    End point title
    Absolute Change From Baseline in IGA at Week 12
    End point description
    The IGA score is an assessment of the participant's disease state at the time of examination and does not attempt a comparison with any of the participant's previous disease states. The IGA utilizes a 6-point scale ranging from 0 to 5 where 0 = clear (no inflammatory signs of AD), 1 = almost clear (just perceptible erythema and papulation induration), 2 = mild (mild erythema and papulation induration; no oozing or crusting), 3 = moderate (moderate erythema and papulation induration; oozing and crusting may be present), 4 = severe (severe erythema and papulation induration; oozing and crusting is present) and 5 = very severe AD. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: units on scale
        least squares mean (standard error)
    -1.13 ± 0.125
    -1.04 ± 0.128
    -1.33 ± 0.13
    -0.92 ± 0.128
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2281
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.57
         upper limit
    0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.179
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5038
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.48
         upper limit
    0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.181
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0258
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    -0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.182

    Secondary: Percentage of Participants Who Achieved an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12

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    End point title
    Percentage of Participants Who Achieved an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
    End point description
    The IGSA score is an assessment of AD signs. Investigator assesses signs in 2 steps: Step 1: Lesional assessment: Investigator chooses the lesional grade that best describes the participant’s involved skin, on average. Step 2: Consider Upgrade or Downgrade: based on skin lesion extent and location. Upgrade refers to the disease extends over the majority (>50% of a region) of one or more body regions, or is prominently affecting high visibility/functionally-important areas (face and hands). Downgrade refers to the disease localized to only one or two small areas (less than 1-2 palms) that are not highly visible or functionally important. A region is defined by i) arms combined, ii) legs combined, iii) trunk, and iv) head and neck, for a total of four regions. The IGSA utilizes a 5-point scale ranging from 0 (clear) to 5 (severe disease) where 0 = clear (no inflammatory signs of AD), 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe AD. mITT population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    30.2 (17.83 to 42.55)
    19.2 (8.52 to 29.94)
    29.4 (16.91 to 41.92)
    22.6 (11.37 to 33.91)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3945
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    7.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.18
         upper limit
    24.27
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.647
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -3.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.96
         upper limit
    12.14
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4395
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    6.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.06
         upper limit
    23.6

    Secondary: Percentage of Participants With a >/=2 Point Reduction From Baseline in IGSA at Week 12

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    End point title
    Percentage of Participants With a >/=2 Point Reduction From Baseline in IGSA at Week 12
    End point description
    The IGSA score is an assessment of AD signs. Investigator assesses signs in 2 steps: Step 1: Lesional assessment: Investigator chooses the lesional grade that best describes the participant’s involved skin, on average. Step 2: Consider Upgrade or Downgrade: based on skin lesion extent and location. Upgrade refers to the disease extends over the majority (>50% of a region) of one or more body regions, or is prominently affecting high visibility/functionally-important areas (face and hands). Downgrade refers to the disease localized to only one or two small areas (less than 1-2 palms) that are not highly visible or functionally important. A region is defined by i) arms combined, ii) legs combined, iii) trunk, and iv) head and neck, for a total of four regions. The IGSA utilizes a 5-point scale ranging from 0 (clear) to 5 (severe disease) where 0 = clear (no inflammatory signs of AD), 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe AD. mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (confidence interval 95%)
    43.4 (30.05 to 56.74)
    26.9 (14.87 to 38.98)
    41.2 (27.67 to 54.68)
    26.4 (14.55 to 38.28)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0729
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    16.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.88
         upper limit
    34.84
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1186
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    14.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.22
         upper limit
    32.74
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9636
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    0.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.41
         upper limit
    17.43

    Secondary: Absolute Change From Baseline in IGSA at Week 12

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    End point title
    Absolute Change From Baseline in IGSA at Week 12
    End point description
    IGSA score is an assessment of AD signs. Investigator assesses signs in 2 steps: Step 1:Lesional assessment:Investigator chooses lesional grade that best describes participant’s involved skin, on average. Step 2: Consider Upgrade or Downgrade:based on skin lesion extent and location. Upgrade refers to disease extends over majority (>50% of a region) of one or more body regions, or is prominently affecting high visibility/functionally-important areas (face and hands). Downgrade refers to disease localized to only one or two small areas (less than 1-2 palms) that are not highly visible or functionally important. A region is defined by i) arms combined, ii) legs combined, iii) trunk, and iv) head and neck, for a total of four regions. IGSA utilizes a 5-point scale ranging from 0 (clear) to 5 (severe disease) where 0=clear(no inflammatory signs of AD), 1=almost clear, 2=mild, 3=moderate, 4=severe AD. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: units on scale
        least squares mean (standard error)
    -1.27 ± 0.136
    -1.14 ± 0.139
    -1.4 ± 0.141
    -1.02 ± 0.14
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2027
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.63
         upper limit
    0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.195
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5316
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.51
         upper limit
    0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.197
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0568
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.199

    Secondary: Percent Change From Baseline in Severity Scoring of Atopic Dermatitis (SCORAD) Index Score at Week 12

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    End point title
    Percent Change From Baseline in Severity Scoring of Atopic Dermatitis (SCORAD) Index Score at Week 12
    End point description
    The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities); and 2) subjective symptoms of pruritus and sleep disturbance as reported by the participant on a visual analog scale (VAS) from 0 to 10 (increasing severity); along with 3) Physician assessment of affected areas (extent) in each region is made as percentage of body surface (head [10%], upper extremities [20%], trunk [30%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: percent change
        least squares mean (standard error)
    -42.63 ± 4.069
    -38.72 ± 4.143
    -53.45 ± 4.218
    -35.41 ± 4.159
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2161
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -7.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.69
         upper limit
    4.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.818
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5734
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -3.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.89
         upper limit
    8.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.873
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0026
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -18.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -29.72
         upper limit
    -6.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.923

    Secondary: Absolute Change From Baseline in SCORAD Index Score at Week 12

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    End point title
    Absolute Change From Baseline in SCORAD Index Score at Week 12
    End point description
    The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities); and 2) subjective symptoms of pruritus and sleep disturbance as reported by the participant on a VAS from 0 to 10 (increasing severity); along with 3) Physician assessment of affected areas (extent) in each region is made as percentage of body surface (head [10%], upper extremities [20%], trunk [30%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: units on scale
        least squares mean (standard error)
    -26.17 ± 2.354
    -22.98 ± 2.395
    -31.84 ± 2.438
    -20.6 ± 2.404
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0989
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -5.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.21
         upper limit
    1.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.364
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4841
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -2.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.07
         upper limit
    4.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.395
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0012
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -11.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.99
         upper limit
    -4.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.423

    Secondary: Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD Index Score (SCORAD-50/SCORAD-75) at Week 12

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    End point title
    Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD Index Score (SCORAD-50/SCORAD-75) at Week 12
    End point description
    The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities); and 2) subjective symptoms of pruritus and sleep disturbance as reported by the participant on a VAS from 0 to 10 (increasing severity); along with 3) Physician assessment of affected areas (extent) in each region is made as percentage of body surface (head [10%], upper extremities [20%], trunk [30%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score. mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
    number (confidence interval 95%)
        SCORAD-50
    47.2 (33.73 to 60.61)
    34.6 (21.68 to 47.55)
    51 (37.26 to 64.7)
    26.4 (14.55 to 38.28)
        SCORAD-75
    11.3 (2.79 to 19.85)
    13.5 (4.18 to 22.74)
    21.6 (10.28 to 32.86)
    13.2 (4.09 to 22.32)
    Statistical analysis title
    Statistical Analysis 1: SCORAD-50
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0297
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    20.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.82
         upper limit
    38.69
    Statistical analysis title
    Statistical Analysis 2: SCORAD-50
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3817
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    8.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.35
         upper limit
    25.75
    Statistical analysis title
    Statistical Analysis 3: SCORAD-50
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0117
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    24.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.42
         upper limit
    42.71
    Statistical analysis title
    Statistical Analysis 4: SCORAD-75
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7636
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -1.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.37
         upper limit
    10.6
    Statistical analysis title
    Statistical Analysis 5: SCORAD-75
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9764
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.75
         upper limit
    13.26
    Statistical analysis title
    Statistical Analysis 6: SCORAD-75
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2663
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    8.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.15
         upper limit
    22.87

    Secondary: Percentage of Participants Who Achieved EASI-50 (50% Reduction From Baseline in EASI Score) at Week 12 and Maintained EASI-50 at Week 16

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    End point title
    Percentage of Participants Who Achieved EASI-50 (50% Reduction From Baseline in EASI Score) at Week 12 and Maintained EASI-50 at Week 16
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (> 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population. Here, N=participants who achieved EASI-50 at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    37
    36
    42
    33
    Units: percentage of participants
        number (confidence interval 95%)
    94.6 (87.31 to 100)
    80.6 (67.63 to 93.48)
    95.2 (88.8 to 100)
    81.8 (68.66 to 94.98)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0991
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    12.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.27
         upper limit
    27.82
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9529
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -1.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.7
         upper limit
    17.18
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0676
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    13.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.23
         upper limit
    28.07

    Secondary: Percentage of Participants Who Achieved EASI-50 (50% Reduction From Baseline in EASI Score) at Week 12 and Maintained EASI-50 at Both Weeks 16 and 20

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    End point title
    Percentage of Participants Who Achieved EASI-50 (50% Reduction From Baseline in EASI Score) at Week 12 and Maintained EASI-50 at Both Weeks 16 and 20
    End point description
    The EASI score was used to measure the severity and extent of AD and measures erythema, induration-papulation, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head and neck, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (> 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. mITT population. Here, N=participants who achieved EASI-50 at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 20
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    37
    36
    42
    33
    Units: percentage of participants
        number (confidence interval 95%)
    78.4 (65.11 to 91.64)
    80.6 (67.63 to 93.48)
    90.5 (81.6 to 99.35)
    72.7 (57.53 to 87.92)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5771
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    5.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.5
         upper limit
    25.82
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3913
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    7.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.1
         upper limit
    27.78
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0477
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    17.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.15
         upper limit
    35.35

    Secondary: Percentage of Participants Who Achieved IGA Score of 0 or 1 at Week 12 and Maintained IGA Score of 0 or 1 at Week 16

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    End point title
    Percentage of Participants Who Achieved IGA Score of 0 or 1 at Week 12 and Maintained IGA Score of 0 or 1 at Week 16
    End point description
    The IGA score is an assessment of AD severity. It is an assessment of the participant's disease state at the time of examination and does not attempt a comparison with any of the participant's previous disease states. The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear (no inflammatory signs of AD), 1 = almost clear (just perceptible erythema and papulation induration), 2 = mild (mild erythema and papulation induration; no oozing or crusting), 3 = moderate (moderate erythema and papulation induration; oozing and crusting may be present), 4 = severe (severe erythema and papulation induration; oozing and crusting is present) and 5 = very severe AD. mITT population. Here, N=participants who achieved IGA score of 0 or 1 at Week 12.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 16
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    15
    11
    17
    10
    Units: percentage of participants
        number (confidence interval 95%)
    60 (35.21 to 84.79)
    72.7 (46.41 to 99.05)
    82.4 (64.23 to 100)
    80 (55.21 to 100)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.254
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -20
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -55.1
         upper limit
    15.06
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8809
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -7.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -43.4
         upper limit
    28.88
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6744
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    2.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.4
         upper limit
    33.06

    Secondary: Percentage of Participants Who Achieved IGA Score of 0 or 1 at Week 12 and Maintained IGA Score of 0 or 1 at Both Weeks 16 and 20

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    End point title
    Percentage of Participants Who Achieved IGA Score of 0 or 1 at Week 12 and Maintained IGA Score of 0 or 1 at Both Weeks 16 and 20
    End point description
    The IGA score is an assessment of AD severity. It is an assessment of the participant's disease state at the time of examination and does not attempt a comparison with any of the participant's previous disease states. The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear (no inflammatory signs of AD), 1 = almost clear (just perceptible erythema and papulation induration), 2 = mild (mild erythema and papulation induration; no oozing or crusting), 3 = moderate (moderate erythema and papulation induration; oozing and crusting may be present), 4 = severe (severe erythema and papulation induration; oozing and crusting is present) and 5 = very severe AD. mITT population. Here, N=participants who achieved IGA score of 0 or 1 at Week 12.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 16, 20
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    15
    11
    17
    10
    Units: percentage of participants
        number (confidence interval 95%)
    60 (35.21 to 84.79)
    54.5 (25.12 to 83.97)
    70.6 (48.93 to 92.25)
    60 (29.64 to 90.36)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9409
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -39.2
         upper limit
    39.2
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9712
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -5.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -47.7
         upper limit
    36.83
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.582
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    10.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.7
         upper limit
    47.89

    Secondary: Percentage of Participants Who Achieved IGSA Score of 0 or 1 at Week 12 and Maintained IGSA Score of 0 or 1 at Week 16

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    End point title
    Percentage of Participants Who Achieved IGSA Score of 0 or 1 at Week 12 and Maintained IGSA Score of 0 or 1 at Week 16
    End point description
    IGSA score is an assessment of AD signs. Investigator assesses signs in 2 steps: Step 1: Lesional assessment: Investigator chooses lesional grade that best describes participant’s involved skin, on average. Step 2: Consider Upgrade or Downgrade: based on skin lesion extent and location. Upgrade refers to disease extends over majority (>50% of a region) of one or more body regions, or is prominently affecting high visibility/functionally-important areas (face and hands). Downgrade refers to disease localized to only one or two small areas (less than 1-2 palms) that are not highly visible or functionally important. A region is defined by i) arms combined, ii) legs combined, iii) trunk, and iv) head and neck, for a total of four regions. IGSA utilizes a 5-point scale ranging from 0 (clear) to 5 (severe disease) where 0=clear (no inflammatory signs of AD), 1=almost clear, 2=mild, 3=moderate, 4=severe AD. mITT population. Here, N=participants who achieved IGSA score of 0 or 1 at Week 12.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 16
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    16
    10
    15
    12
    Units: percentage of participants
        number (confidence interval 95%)
    62.5 (38.78 to 86.22)
    80 (55.21 to 100)
    73.3 (50.95 to 95.71)
    83.3 (62.25 to 100)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1708
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -20.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -52.6
         upper limit
    10.91
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8752
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -3.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.9
         upper limit
    29.21
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9458
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -40.7
         upper limit
    20.75

    Secondary: Percentage of Participants Who Achieved IGSA Score of 0 or 1 at Week 12 and Maintained IGSA Score of 0 or 1 at Both Weeks 16 and 20

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    End point title
    Percentage of Participants Who Achieved IGSA Score of 0 or 1 at Week 12 and Maintained IGSA Score of 0 or 1 at Both Weeks 16 and 20
    End point description
    IGSA score is an assessment of AD signs. Investigator assesses signs in 2 steps: Step 1: Lesional assessment: Investigator chooses lesional grade that best describes participant’s involved skin, on average. Step 2: Consider Upgrade or Downgrade: based on skin lesion extent and location. Upgrade refers to disease extends over majority (>50% of a region) of one or more body regions, or is prominently affecting high visibility/functionally-important areas (face and hands). Downgrade refers to disease localized to only one or two small areas (less than 1-2 palms) that are not highly visible or functionally important. A region is defined by i) arms combined, ii) legs combined, iii) trunk, and iv) head and neck, for a total of four regions. IGSA utilizes a 5-point scale ranging from 0 (clear) to 5 (severe disease) where 0=clear (no inflammatory signs of AD), 1=almost clear, 2=mild, 3=moderate, 4=severe AD. mITT population. Here, N=participants who achieved IGSA score of 0 or 1 at Week 12.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 16, 20
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    16
    10
    15
    12
    Units: percentage of participants
        number (confidence interval 95%)
    56.3 (31.94 to 80.56)
    60 (29.64 to 90.36)
    60 (35.21 to 84.79)
    50 (21.71 to 78.29)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9439
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    6.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31
         upper limit
    43.55
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6297
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.5
         upper limit
    51.5
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5347
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -27.6
         upper limit
    47.62

    Secondary: Percentage of Participants Who Achieved SCORAD-50 (50% Reduction From Baseline in SCORAD Index Score) at Week 12 and Maintained SCORAD-50 at Week 16

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    End point title
    Percentage of Participants Who Achieved SCORAD-50 (50% Reduction From Baseline in SCORAD Index Score) at Week 12 and Maintained SCORAD-50 at Week 16
    End point description
    The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities); and 2) subjective symptoms of pruritus and sleep disturbance as reported by the participant on a VAS from 0 to 10 (increasing severity); along with 3) Physician assessment of affected areas (extent) in each region is made as percentage of body surface (head [10%], upper extremities [20%], trunk [30%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score. mITT population. Here, N=participants who achieved SCORAD-50 at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    25
    18
    26
    14
    Units: percentage of participants
        number (confidence interval 95%)
    72 (54.4 to 89.6)
    72.2 (51.53 to 92.91)
    76.9 (60.73 to 93.12)
    85.7 (67.38 to 100)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4875
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -13.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -39.1
         upper limit
    11.7
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3375
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -13.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -41.1
         upper limit
    14.15
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1334
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -8.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -33.3
         upper limit
    15.67

    Secondary: Percentage of Participants Who Achieved SCORAD-50 (50% Reduction From Baseline in SCORAD Index Score) at Week 12 and Maintained SCORAD-50 at Both Weeks 16 and 20

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    End point title
    Percentage of Participants Who Achieved SCORAD-50 (50% Reduction From Baseline in SCORAD Index Score) at Week 12 and Maintained SCORAD-50 at Both Weeks 16 and 20
    End point description
    The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities); and 2) subjective symptoms of pruritus and sleep disturbance as reported by the participant on a VAS from 0 to 10 (increasing severity); along with 3) Physician assessment of affected areas (extent) in each region is made as percentage of body surface (head [10%], upper extremities [20%], trunk [30%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score. mITT population. Here, N=participants who achieved SCORAD-50 at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 20
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    25
    18
    26
    14
    Units: percentage of participants
        number (confidence interval 95%)
    64 (45.18 to 82.82)
    61.1 (38.59 to 83.63)
    50 (30.78 to 69.22)
    78.6 (57.08 to 100)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4852
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -14.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -43.1
         upper limit
    13.99
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3375
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -17.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -48.6
         upper limit
    13.67
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    CMH chi-square test was stratified by geographic region (US/Canada versus Europe versus others). 95% CI was based on normal approximation for binomial proportion.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1334
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    -28.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -57.4
         upper limit
    0.26

    Secondary: Percent Change From Baseline in Total % Body Surface Area (BSA) Affected With AD at Week 12

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    End point title
    Percent Change From Baseline in Total % Body Surface Area (BSA) Affected With AD at Week 12
    End point description
    Affected BSA was assessed for each of the following four body regions: head and neck, upper limbs, trunk, and lower limbs. Affected BSA was assessed on a 7-point ordinal scale, where 0=no eruption, 1=<10%, 2=>10%-29%, 3=>30%-49%, 4=>50%-69%, 5=>70%-89%, and 6=>90%-100%. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: percent change
        least squares mean (standard error)
    -38.6 ± 8.069
    -45.2 ± 8.206
    -57.68 ± 8.35
    -47.42 ± 8.242
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4453
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    8.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.93
         upper limit
    31.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.541
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8487
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    2.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.7
         upper limit
    25.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.625
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3835
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -10.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -33.39
         upper limit
    12.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.736

    Secondary: Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12

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    End point title
    Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
    End point description
    Pruritus VAS score was measured as a part of SCORAD. Subjective symptoms of pruritus were reported by the participant on a VAS. VAS is an eleven point scale ranging from 0 (no pruritus) to 10 centimeters (cm) (most severe pruritus). mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: cm
        least squares mean (standard error)
    -2.03 ± 0.325
    -2.06 ± 0.331
    -2.53 ± 0.336
    -1.83 ± 0.332
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6591
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.12
         upper limit
    0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.464
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6223
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.16
         upper limit
    0.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.469
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1391
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.63
         upper limit
    0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.472

    Secondary: Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12

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    End point title
    Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
    End point description
    Pruritus VAS score was measured as a part of SCORAD. Subjective symptoms of pruritus were reported by the participant on a VAS. VAS is an eleven point scale ranging from 0 (no pruritus) to 10 centimeters (cm) (most severe pruritus). mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    50
    49
    50
    Units: percent change
        least squares mean (standard error)
    -32.82 ± 5.953
    -34.92 ± 6.143
    -40.71 ± 6.188
    -27.54 ± 6.124
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5374
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -5.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.12
         upper limit
    11.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.54
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.396
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -7.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -24.5
         upper limit
    9.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.679
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.132
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -13.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -30.34
         upper limit
    4
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.706

    Secondary: Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12

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    End point title
    Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
    End point description
    The 5-D itch scale is a 5-item, validated questionnaire used to evaluate change in itch over time. The 5-D itch scale refers to the previous 2 weeks and the questions are organized into 5 domains: duration, degree, direction, disability, and distribution. The total 5-D itch score is calculated by summing each of the separately scored 5 domains. Total score ranges between 5 (no pruritus) and 25 (most severe pruritus). Higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: units on scale
        least squares mean (standard error)
    -3.24 ± 0.557
    -2.26 ± 0.57
    -3.74 ± 0.581
    -2.55 ± 0.57
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3842
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.27
         upper limit
    0.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.798
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7226
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.31
         upper limit
    1.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.809
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1446
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.79
         upper limit
    0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.813

    Secondary: Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12

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    End point title
    Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
    End point description
    The 5-D itch scale is a 5-item, validated questionnaire used to evaluate change in itch over time. The 5-D itch scale refers to the previous 2 weeks and the questions are organized into 5 domains: duration, degree, direction, disability, and distribution. The total 5-D itch score is calculated by summing each of the separately scored 5 domains. Total score ranges between 5 (no pruritus) and 25 (most severe pruritus). Higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: percent change
        least squares mean (standard error)
    -15.23 ± 3.71
    -10.57 ± 3.798
    -20.51 ± 3.877
    -13.05 ± 3.799
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6816
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -2.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.66
         upper limit
    8.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.313
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6464
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    2.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.15
         upper limit
    13.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.385
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1697
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -7.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.15
         upper limit
    3.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.419

    Secondary: Total Amount of TCS Used From Baseline to Week 12

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    End point title
    Total Amount of TCS Used From Baseline to Week 12
    End point description
    Total amount of TCS (Triamcinolone acetonide 0.1% cream or hydrocortisone 2.5% cream) used in grams from baseline to Week 12 was reported. mITT population. Here, n=participants who used triamcinolone acetonide 0.1% cream or hydrocortisone 2.5% cream at specified time-point per arm, respectively.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: grams
    arithmetic mean (standard deviation)
        Triamcinolone acetonide 0.1% (n=33, 32, 42, 29)
    608.7 ± 740
    510.2 ± 478.5
    669.4 ± 975
    699.9 ± 687.5
        Hydrocortisone 2.5% (n=27, 32, 32, 32)
    28.2 ± 26.2
    36.2 ± 68.2
    29.3 ± 32.2
    38.9 ± 66.6
    No statistical analyses for this end point

    Secondary: Total Amount of TCS Used From Week 12 to End of Study or Early Termination

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    End point title
    Total Amount of TCS Used From Week 12 to End of Study or Early Termination
    End point description
    Total amount of TCS (Triamcinolone acetonide 0.1% cream or hydrocortisone 2.5% cream) in grams used from Week 12 to the end of study or early termination was reported. mITT population. Here, n=participants who used triamcinolone acetonide 0.1% cream or hydrocortisone 2.5% cream at specified time-point per arm, respectively.
    End point type
    Secondary
    End point timeframe
    From Week 12 to end of study or early termination (up to 20 weeks)
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: grams
    arithmetic mean (standard deviation)
        Triamcinolone acetonide 0.1% (n=36, 40, 43, 36)
    459.4 ± 630.1
    379.4 ± 443.5
    279.4 ± 243.2
    415.1 ± 414.4
        Hydrocortisone 2.5% (n=32, 36, 34, 34)
    15 ± 16.5
    15 ± 25
    19.4 ± 22.4
    16 ± 19.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced AD Disease Flares From Baseline to Week 12

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    End point title
    Percentage of Participants Who Experienced AD Disease Flares From Baseline to Week 12
    End point description
    Disease flare was defined as a measurable increase in extent or severity of lesions over a period of at least 3 days, under continued treatment and corresponding with a clinically significant increase in disease severity (as assessed by the treating physician and/or by the participant) necessitating an escalation in therapy, as defined by the protocol or initiated separately by the participant or a treating physician outside of the protocol. mITT population.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    53
    52
    51
    53
    Units: percentage of participants
        number (not applicable)
    5.7
    0
    2
    5.7
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in AD Symptoms at Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)

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    End point title
    Absolute Change From Baseline in AD Symptoms at Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
    End point description
    The 8-item ADSD was used to assess participants’ AD symptoms; specifically, itchiness, skin pain, bleeding, skin sensitivity, skin irritation, skin flakiness, skin dryness, and weeping or oozing of clear fluid from the skin. The diary items were assessed on an 11-point numeric rating scale ranging from 0 (no symptom) to 10 (symptom as bad as one can imagine) and a Yes/No wake question. The diary had a recall specification of 24 hours. Scores of individual items were added to yield a total ADSD score (0-80), where higher scores mean worst symptom. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    33
    33
    32
    37
    Units: units on scale
        least squares mean (standard error)
    -11.3 ± 1.963
    -10.32 ± 1.815
    -11.82 ± 1.837
    -9.49 ± 1.96
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5143
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.31
         upper limit
    3.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.776
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7552
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.12
         upper limit
    4.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.671
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3878
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -2.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.66
         upper limit
    2.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.691

    Secondary: Percent Change From Baseline in AD Symptoms at Week 12, as Assessed by the ADSD

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    End point title
    Percent Change From Baseline in AD Symptoms at Week 12, as Assessed by the ADSD
    End point description
    The 8-item ADSD was used to assess participants’ AD symptoms; specifically, itchiness, skin pain, bleeding, skin sensitivity, skin irritation, skin flakiness, skin dryness, and weeping or oozing of clear fluid from the skin. The diary items were assessed on an 11-point numeric rating scale ranging from 0 (no symptom) to 10 (symptom as bad as one can imagine) and a Yes/No wake question. The diary had a recall specification of 24 hours. Scores of individual items were added to yield a total ADSD score (0-80), where higher scores mean worst symptom. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    33
    33
    32
    37
    Units: percent change
        least squares mean (standard error)
    -14.23 ± 12.981
    -18.21 ± 12.011
    -40.31 ± 12.224
    -32.91 ± 12.897
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3096
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    18.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.56
         upper limit
    54.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    18.315
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4058
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    14.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.18
         upper limit
    49.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.626
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6782
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -7.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -42.59
         upper limit
    27.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.791

    Secondary: Absolute Change From Baseline in AD-Specific Health-Related Quality of Life (QoL) at Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)

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    End point title
    Absolute Change From Baseline in AD-Specific Health-Related Quality of Life (QoL) at Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)
    End point description
    The ADIQ is a 17-item questionnaire used to assess the participants’ AD-specific health-related QoL. The questionnaire assesses AD’s impact on emotions, energy, activities of daily living, and social activities. The ADIQ had a recall specification of 7 days. The questions were assessed on a 5-point likert scale: 0 (not at all), 1 (a little), 2 (somewhat), 3 (quite a bit), and 4 (extreme). Scores of individual items were added to yield a total ADIQ score (0-68), where higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: units on scale
        least squares mean (standard error)
    -10.92 ± 1.551
    -9.28 ± 1.58
    -12.75 ± 1.607
    -6.24 ± 1.578
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0357
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -4.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.05
         upper limit
    -0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.214
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1751
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -3.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.45
         upper limit
    1.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.234
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0043
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -6.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.95
         upper limit
    -2.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.251

    Secondary: Percent Change From Baseline in AD-Specific Health-Related QoL at Week 12, as Assessed by the ADIQ

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    End point title
    Percent Change From Baseline in AD-Specific Health-Related QoL at Week 12, as Assessed by the ADIQ
    End point description
    The ADIQ is a 17-item questionnaire used to assess the participants’ AD-specific health-related QoL. The questionnaire assesses AD’s impact on emotions, energy, activities of daily living, and social activities. The ADIQ had a recall specification of 7 days. The questions were assessed on a 5-point likert scale: 0 (not at all), 1 (a little), 2 (somewhat), 3 (quite a bit), and 4 (extreme). Scores of individual items were added to yield a total ADIQ score (0-68), where higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: percent change
        least squares mean (standard error)
    -30.79 ± 8.989
    -33.2 ± 9.153
    -54.29 ± 9.173
    -29.49 ± 9.133
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9193
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.59
         upper limit
    23.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.818
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7742
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -3.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -29.23
         upper limit
    21.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.934
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0568
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -24.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -50.33
         upper limit
    0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.94

    Secondary: Absolute Change From Baseline in Health-Related QoL at Week 12, as Measured by the Dermatology Life Quality Index (DLQI)

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    End point title
    Absolute Change From Baseline in Health-Related QoL at Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
    End point description
    The DLQI is a 10-item, validated questionnaire used routinely in clinical practice to evaluate the impact of dermatologic diseases on participants' lives. The DLQI refers to the previous 7 days and questions are categorized into six domains: symptoms and feelings (2 items), daily activities (2 items), leisure (2 items), work and school (1 item), personal relationships (2 items), and treatment (1 item). The questions were assessed on a 4-point likert scale: 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items were added to yield a total DLQI score (0-30), where higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: units on scale
        least squares mean (standard error)
    -5.64 ± 0.653
    -5.45 ± 0.665
    -5.15 ± 0.678
    -4.52 ± 0.666
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2313
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.96
         upper limit
    0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.933
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3229
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.79
         upper limit
    0.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.943
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5045
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.51
         upper limit
    1.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.949

    Secondary: Percent Change From Baseline in Health-Related QoL at Week 12, as Measured by the DLQI

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    End point title
    Percent Change From Baseline in Health-Related QoL at Week 12, as Measured by the DLQI
    End point description
    The DLQI is a 10-item, validated questionnaire used routinely in clinical practice to evaluate the impact of dermatologic diseases on participants' lives. The DLQI refers to the previous 7 days and questions are categorized into six domains: symptoms and feelings (2 items), daily activities (2 items), leisure (2 items), work and school (1 item), personal relationships (2 items), and treatment (1 item). The questions were assessed on a 4-point likert scale: 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items were added to yield a total DLQI score (0-30), where higher scores mean greater impairment of the participant’s health-related QoL. mITT population. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    49
    45
    49
    Units: percent change
        least squares mean (standard error)
    -40.67 ± 6.691
    -34.33 ± 6.929
    -43.12 ± 7.017
    -33.57 ± 6.928
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with exchangeable covariance structure.
    Comparison groups
    Lebrikizumab 250 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4621
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -7.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.04
         upper limit
    11.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.637
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Single Dose + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9383
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.04
         upper limit
    18.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.809
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Adjusted mean and SE was calculated using linear mixed effects model including fixed effects of baseline value, treatment arm, visit, treatment by visit interaction, and geographic region; participant was included in the model as random effects with unstructured covariance structure.
    Comparison groups
    Lebrikizumab 125 mg Q4W + TCS v Placebo Q4W + TCS Cream
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.333
    Method
    Mixed models analysis
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -9.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.91
         upper limit
    9.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.85

    Secondary: Number of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab

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    End point title
    Number of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab
    End point description
    Safety evaluable (SE) population was defined as participants who received at least one dose of the study treatment. Participants were analysed as per actual treatment received. Here, N=participants evaluable for this outcome. n=participants evaluable for specified category, per arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose on Day 1), post-baseline (pre-dose on Days 29, 85,141, study discontinuation visit [up to Day 141])
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    53
    50
    53
    Units: participants
        Baseline (n=51, 53, 50, 53)
    4
    1
    5
    2
        Post-baseline (n=52,53,50,52)
    8
    19
    11
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein

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    End point title
    Number of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein
    End point description
    Treatment-induced PLBL2 = a participant with negative or missing baseline PLBL2 result and at least one positive post-baseline PLBL2 result. Treatment-enhanced PLBL2 = a participant with positive PLBL2 result at baseline who had one or more post-baseline titer results that were at least 0.60 t.u. greater than the baseline titer result. SE population. Participants were analysed as per actual treatment received. Here, N=participants evaluable for this outcome. n=participants evaluable for specified category, per arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose on Day 1), post-baseline (pre-dose on Days 29, 85,141, study discontinuation visit [up to Day 141])
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    51
    52
    50
    53
    Units: participants
        Baseline (n=51, 52, 50, 53)
    1
    0
    2
    1
        Post-baseline:Treatment-induced (n=51, 48, 49, 50)
    1
    1
    2
    0
        Post-baseline:Treatment-enhanced(n=51, 48, 49, 50)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Disease Rebound

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    End point title
    Percentage of Participants With Disease Rebound
    End point description
    Disease rebound was defined as a significant worsening of disease severity after cessation of therapy to a severity level that is greater than prior to commencing therapy. SE population.
    End point type
    Secondary
    End point timeframe
    From Week 12 up to 20 weeks
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Number of subjects analysed
    52
    54
    50
    53
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    1.9
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Concentration (Cmax) of Lebrikizumab

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    End point title
    Maximum Observed Serum Concentration (Cmax) of Lebrikizumab
    End point description
    SE population, only participants who received lebrikizumab were to be analysed for this outcome. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    After first dose of lebrikizumab at Week 1
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS
    Number of subjects analysed
    51
    54
    50
    Units: micrograms per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    35.6 ± 10.8
    17 ± 5.22
    16.1 ± 5.19
    No statistical analyses for this end point

    Secondary: Time to Reach Cmax (Tmax) of Lebrikizumab

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    End point title
    Time to Reach Cmax (Tmax) of Lebrikizumab
    End point description
    SE population, only participants who received lebrikizumab were to be analysed for this outcome. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    After first dose of lebrikizumab at Week 1
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS
    Number of subjects analysed
    51
    54
    50
    Units: days
        median (full range (min-max))
    6.97 (4.88 to 14.9)
    6.98 (4.92 to 14.6)
    6.96 (1.98 to 10.3)
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentration (Cmin) of Lebrikizumab

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    End point title
    Minimum Serum Concentration (Cmin) of Lebrikizumab
    End point description
    SE population, only participants who received lebrikizumab were to be analysed for this outcome. Here, N=participants analysed for this outcome. n=participants analysed at specified time-point.
    End point type
    Secondary
    End point timeframe
    Pre-dose (Hour 0) at Weeks 4, 8, 12
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS
    Number of subjects analysed
    52
    53
    50
    Units: mcg/mL
    arithmetic mean (standard deviation)
        Week 4 (n=51, 53, 50)
    21.4 ± 6.87
    10.2 ± 3
    9.15 ± 2.99
        Week 8 (n=52, 50, 46)
    9.53 ± 3.53
    4.59 ± 2.12
    13.6 ± 5.34
        Week 12 (n=50, 49, 46)
    3.77 ± 2.01
    2.28 ± 1.72
    14.4 ± 5.69
    No statistical analyses for this end point

    Secondary: Elimination Half-Life (t1/2) of Lebrikizumab

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    End point title
    Elimination Half-Life (t1/2) of Lebrikizumab
    End point description
    SE population, only participants who received lebrikizumab were to be analysed for this outcome. Here, N=participants analysed for this outcome.
    End point type
    Secondary
    End point timeframe
    Pre-dose (Hour 0) on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141)
    End point values
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS
    Number of subjects analysed
    52
    52
    48
    Units: days
        arithmetic mean (standard deviation)
    22.2 ± 6.18
    18.5 ± 5.06
    20.9 ± 4.17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening up to Week 20
    Adverse event reporting additional description
    SE population
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Lebrikizumab 250 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Single Dose + TCS
    Reporting group description
    Participants received a single dose of lebrikizumab 125 mg SC injection on Day 1 followed by placebo on Week 4 and Week 8. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Lebrikizumab 125 mg Q4W + TCS
    Reporting group description
    Participants received lebrikizumab 125 mg SC injection every 4 weeks (Q4W) for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Reporting group title
    Placebo Q4W + TCS Cream
    Reporting group description
    Participants received placebo Q4W for a total of 3 doses. Participants continued to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

    Serious adverse events
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 54 (5.56%)
    2 / 50 (4.00%)
    2 / 53 (3.77%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sensory loss
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolothiasis
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rebound atopic dermatitis
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative abcess
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lebrikizumab 250 mg Single Dose + TCS Lebrikizumab 125 mg Single Dose + TCS Lebrikizumab 125 mg Q4W + TCS Placebo Q4W + TCS Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 52 (42.31%)
    23 / 54 (42.59%)
    16 / 50 (32.00%)
    19 / 53 (35.85%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 52 (7.69%)
    0 / 54 (0.00%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 54 (3.70%)
    4 / 50 (8.00%)
    2 / 53 (3.77%)
         occurrences all number
    8
    3
    4
    2
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 54 (7.41%)
    2 / 50 (4.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    4
    3
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 54 (5.56%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    3
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 54 (0.00%)
    1 / 50 (2.00%)
    3 / 53 (5.66%)
         occurrences all number
    3
    0
    1
    3
    Pruritus
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 54 (7.41%)
    3 / 50 (6.00%)
    1 / 53 (1.89%)
         occurrences all number
    2
    4
    3
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 54 (5.56%)
    0 / 50 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    3
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    8 / 52 (15.38%)
    10 / 54 (18.52%)
    5 / 50 (10.00%)
    8 / 53 (15.09%)
         occurrences all number
    10
    13
    8
    9
    Postoperative wound infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 50 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    1
    0
    0
    4
    Rhinitis
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 54 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    3
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 52 (1.92%)
    7 / 54 (12.96%)
    2 / 50 (4.00%)
    5 / 53 (9.43%)
         occurrences all number
    1
    7
    4
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2015
    - Antiviral medication to treat herpes zoster was deleted from the list of therapies permitted during the study. - Herpes zoster infection was added as a reason requiring study treatment discontinuation.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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