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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-000331-27
    Trial protocol
    		 GB   DE   CZ   PL  
    Global end of trial date
    03 Dec 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jun 2023
    First version publication date
    26 Mar 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor updates made for consistency.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ANB020-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03533751
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AnaptysBio, Inc
    Sponsor organisation address
    10421 Pacific Center Court, Suite 200, San Diego, United States, CA 92121
    Public contact
    AnaptysBio Clinical Trials Information, AnaptysBio, Inc, +1 8583626295, clinicaltrialinfo@anaptysbio.com
    Scientific contact
    AnaptysBio Clinical Trials Information, AnaptysBio, Inc, +1 8583626295, clinicaltrialinfo@anaptysbio.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
    03 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the effects of etokimab (ANB020) on skin lesions.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: • Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines; • Applicable International Council for Harmonisation Good Clinical Practice Guidelines; • Applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    United States: 134
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Czechia: 46
    Country: Number of subjects enrolled
    United Kingdom: 35
    Worldwide total number of subjects
    302
    EEA total number of subjects
    112
    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)
    279
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 75 centers in the United States, United Kingdom, Canada, Czech Republic, Germany, and Poland. The study enrolled adults with moderate to severe atopic dermatitis (AD). The study included a treatment period of 16 weeks (Week 0 to 16) followed by a safety follow-up for 8 weeks (Week 16 to Week 24).

    Pre-assignment
    Screening details
    		 Participants were equally randomized on Day 1 to one of five treatment groups. Two participants in the etokimab 300 mg/placebo 150 mg subcutaneous (SC) every 8 weeks (Q8W) group were randomized to treatment but never received treatment (1 participant withdrew consent prior to dosing and 1 participant was lost to follow-up prior to dosing).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was formulated as a sterile solution in single use glass vials containing 1.2 milliliters (mL) of solution.

    Arm title
    		 Etokimab 20 mg SC Q4W
    Arm description
    		 Participants received etokimab 20 milligrams (mg) administered SC every 4 weeks (Q4W) for up to 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etokimab
    Investigational medicinal product code
    ANB020
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etokimab was formulated as a sterile solution in single use glass vials containing 1.2 mL of solution.

    Arm title
    		 Etokimab 300 mg / 150 mg SC Q8W
    Arm description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q8W for up to 16 weeks. At Weeks 4 and 12 participants received placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was formulated as a sterile solution in single use glass vials containing 1.2 mL of solution.

    Investigational medicinal product name
    Etokimab
    Investigational medicinal product code
    ANB020
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etokimab was formulated as a sterile solution in single use glass vials containing 1.2 mL of solution.

    Arm title
    		 Etokimab 300 mg / 150 mg SC Q4W
    Arm description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etokimab
    Investigational medicinal product code
    ANB020
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etokimab was formulated as a sterile solution in single use glass vials containing 1.2 mL of solution.

    Arm title
    		 Etokimab 600 mg / 300 mg SC Q4W
    Arm description
    		 Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etokimab
    Investigational medicinal product code
    ANB020
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etokimab was formulated as a sterile solution in single use glass vials containing 1.2 mL of solution.

    Number of subjects in period 1 [1]
    		Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Started
    60
    61
    59
    60
    60
    Completed
    41
    36
    39
    40
    37
    Not completed
    19
    25
    20
    20
    23
         Consent withdrawn by subject
    12
    6
    10
    9
    10
         Physician decision
    -
    2
    1
    2
    1
         Adverse event, non-fatal
    4
    7
    2
    4
    5
         Other
    -
    2
    1
    -
    3
         Use of any excluded/prohibited medications
    -
    1
    -
    -
    1
         Lost to follow-up
    3
    7
    5
    4
    3
         Sponsor decision
    -
    -
    1
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number enrolled includes all participants randomized (ie, 302 participants) to treatment. Two participants were randomized but never received study drug. Baseline period is based on participants who were randomized and who received study drug (ie, 300 participants).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 20 mg SC Q4W
    Reporting group description
    		 Participants received etokimab 20 milligrams (mg) administered SC every 4 weeks (Q4W) for up to 16 weeks.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q8W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q8W for up to 16 weeks. At Weeks 4 and 12 participants received placebo.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q4W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 600 mg / 300 mg SC Q4W
    Reporting group description
    		 Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.

    Reporting group values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W Total
    Number of subjects
    		 60 61 59 60 60 300
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.5 ± 15.92 40.1 ± 16.76 39.7 ± 14.38 38.9 ± 14.61 37.1 ± 14.78 -
    Gender categorical
    Units: Subjects
        Female
    		 29 25 36 24 32 146
        Male
    		 31 36 23 36 28 154
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 2 3
        Asian
    		 5 2 0 0 6 13
        Black or African American
    		 6 9 10 4 6 35
        White
    		 49 48 46 55 45 243
        Other
    		 0 1 3 1 1 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 10 11 8 8 7 44
        Not Hispanic or Latino
    		 50 49 51 50 53 253
        Not Reported
    		 0 1 0 1 0 2
        Unknown
    		 0 0 0 1 0 1
    Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD)
    The vIGA-AD is a 5-point scale to evaluate AD severity: • 0: Clear - No inflammatory signs of AD (erythema, induration/papulation, lichenification, oozing/crusting) • 1: Almost clear - Barely perceptible erythema, induration/papulation, minimal lichenification • 2: Mild - Slight but definite erythema, induration/papulation, or lichenification. No oozing/crusting • 3: Moderate - Clearly perceptible erythema, induration/papulation, or lichenification. Oozing or crusting may be present • 4: Severe - Marked erythema, induration/papulation, or lichenification. Oozing or crusting may be present
    Units: Subjects
        Grade 0 (Clear)
    		 0 0 0 0 0 0
        Grade 1 (Almost clear)
    		 0 0 0 0 0 0
        Grade 2 (Mild)
    		 0 0 0 0 0 0
        Grade 3 (Moderate)
    		 49 36 43 43 38 209
        Grade 4 (Severe)
    		 10 25 16 17 22 90
        Missing
    		 1 0 0 0 0 1
    Eczema Area and Severity Index (EASI)
    EASI measures the extent and severity of atopic eczema of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region, percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, edema), scratching (excoriation) and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease). In placebo group, 59 participants were evaluable.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 26.6 ± 11.45 29.8 ± 12.08 27.1 ± 10.38 32.2 ± 13.06 29.5 ± 12.19 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 20 mg SC Q4W
    Reporting group description
    		 Participants received etokimab 20 milligrams (mg) administered SC every 4 weeks (Q4W) for up to 16 weeks.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q8W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q8W for up to 16 weeks. At Weeks 4 and 12 participants received placebo.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q4W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 600 mg / 300 mg SC Q4W
    Reporting group description
    		 Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.

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

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    End point title
    		 Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
    End point description
    EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease). The full analysis set included all randomized subjects who received 1 dose of etokimab or placebo and had baseline and post-baseline EASI scores. Missing data were imputed using multiple imputation.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: percent change
        least squares mean (standard error)
    -49.38 ± 7.124
    -41.63 ± 6.707
    -55.70 ± 6.206
    -47.40 ± 6.091
    -44.56 ± 7.811
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline EASI as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4498
    Method
    		 ANCOVA
    Parameter type
    		 Least squares (LS) mean difference
    Point estimate
    7.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4066
         upper limit
    		 27.8983
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.235
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline EASI as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.501
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -6.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.774
         upper limit
    		 12.1262
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.39
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline EASI as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8349
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.6037
         upper limit
    		 20.5476
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.454
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline EASI as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6662
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    4.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.1892
         upper limit
    		 26.8275
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.154

    Secondary: Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16

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    End point title
    		 Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16
    End point description
    EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease). Full Analysis Set. Participants with missing data were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: subjects
    21
    19
    27
    21
    18
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7992
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.9509
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2197
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.757
         upper limit
    		 3.3572
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7197
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5345
         upper limit
    		 2.4774
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6772
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.391
         upper limit
    		 1.8404

    Secondary: Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16

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    End point title
    		 Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16
    End point description
    EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease). Full Analysis Set. Participants with missing data were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: subjects
    10
    10
    14
    12
    11
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9537
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3922
         upper limit
    		 2.6994
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3316
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6323
         upper limit
    		 3.8895
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5166
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5331
         upper limit
    		 3.4944
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7426
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4545
         upper limit
    		 3.0223

    Secondary: Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16

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    End point title
    		 Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16
    End point description
    EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease). Full Analysis Set. Participants with missing data were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: subjects
    3
    5
    7
    7
    2
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4543
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3998
         upper limit
    		 7.7615
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1874
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6314
         upper limit
    		 10.4827
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1721
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6506
         upper limit
    		 11.0814
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics from a logistic regression model with treatment as fixed effect and baseline EASI as a covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6755
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1086
         upper limit
    		 4.2141

    Secondary: Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16

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    End point title
    		 Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16
    End point description
    The vIGA-AD is a static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present 1: Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting 2: Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting 3: Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present 4: Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present. Number of participants with ≥2 points reduction in vIGA-AD is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60 [1]
    61 [2]
    59 [3]
    60 [4]
    60 [5]
    Units: subjects
    8
    7
    8
    10
    9
    Notes
    [1] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [2] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [3] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [4] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [5] - Full Analysis Set. Participants with missing data were counted as non-responders.
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6058
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2481
         upper limit
    		 2.2543
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9521
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3356
         upper limit
    		 2.7923
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6905
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4457
         upper limit
    		 3.3878
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9399
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3671
         upper limit
    		 2.9518

    Secondary: Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16

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    End point title
    		 Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16
    End point description
    vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present 1: Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting 2: Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting 3: Moderate- Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present 4: Severe- Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present. Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60 [6]
    61 [7]
    59 [8]
    60 [9]
    60 [10]
    Units: subjects
    5
    5
    6
    8
    6
    Notes
    [6] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [7] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [8] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [9] - Full Analysis Set. Participants with missing data were counted as non-responders.
    [10] - Full Analysis Set. Participants with missing data were counted as non-responders.
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7659
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.329
         upper limit
    		 4.5268
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6273
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3895
         upper limit
    		 4.776
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2967
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5734
         upper limit
    		 6.1879
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5544
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4152
         upper limit
    		 5.1476

    Secondary: Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16

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    End point title
    		 Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16
    End point description
    Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit. Full Analysis Set. Participants with missing data were counted as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: subjects
    5
    6
    8
    9
    9
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3175
         upper limit
    		 3.9513
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3222
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5511
         upper limit
    		 6.1214
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2564
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6089
         upper limit
    		 6.431
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    Inferential statistics based on a Logistic regression model with treatment as fixed effect and baseline test score as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2912
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5806
         upper limit
    		 6.1275

    Secondary: Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16

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    End point title
    		 Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16
    End point description
    Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit. Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    56
    58
    52
    54
    54
    Units: percent change
        least squares mean (standard error)
    -21.13 ± 5.964
    -22.30 ± 6.211
    -17.69 ± 6.530
    -30.39 ± 6.176
    -27.18 ± 6.192
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline Peak Weekly Averaged NRS as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8927
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.2117
         upper limit
    		 15.8686
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.679
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline Peak Weekly Averaged NRS as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7035
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.2767
         upper limit
    		 21.1463
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.019
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline Peak Weekly Averaged NRS as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2819
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -9.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.159
         upper limit
    		 7.6237
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.608
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline Peak Weekly Averaged NRS as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4793
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -6.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.8452
         upper limit
    		 10.7333
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.557

    Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16

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    End point title
    		 Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
    End point description
    SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as extent of disease (0 [no disease]-102 [worst disease]). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 [no itch] to 10 [worst imaginable itch] and sleeplessness: 0 [no sleeplessness] to 10 [worst imaginable sleeplessness]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst). Full Analysis Set. Missing data were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: percent change
        least squares mean (standard error)
    -37.99 ± 4.764
    -31.42 ± 4.605
    -39.22 ± 4.294
    -35.48 ± 4.401
    -31.23 ± 4.927
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline SCORAD as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3262
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    6.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5723
         upper limit
    		 19.7054
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.677
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline SCORAD as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8465
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.7439
         upper limit
    		 11.2782
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.366
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline SCORAD as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6947
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.0587
         upper limit
    		 15.082
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.396
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline SCORAD as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3288
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    6.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8451
         upper limit
    		 20.3626
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.909

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

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
    End point description
    The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant’s QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement. Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    59
    60
    Units: units on a scale
        least squares mean (standard error)
    -5.61 ± 0.946
    -5.35 ± 0.966
    -6.52 ± 0.945
    -6.05 ± 0.945
    -5.18 ± 1.036
    Statistical analysis title
    		 Placebo Vs Etokimab 20 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline DLQI score as covariate.
    Comparison groups
    Placebo v Etokimab 20 mg SC Q4W
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8497
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4081
         upper limit
    		 2.9218
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.355
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q8W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline DLQI score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q8W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5016
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5636
         upper limit
    		 1.7473
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35
    Statistical analysis title
    		 Placebo Vs Etokimab 300 mg / 150 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline DLQI score as covariate.
    Comparison groups
    Placebo v Etokimab 300 mg / 150 mg SC Q4W
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7511
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.167
         upper limit
    		 2.287
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.386
    Statistical analysis title
    		 Placebo Vs Etokimab 600 mg / 300 mg SC Q4W
    Statistical analysis description
    The p-value was obtained using mixed effect ANCOVA model with treatment as fixed effect and baseline DLQI score as covariate.
    Comparison groups
    Placebo v Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7558
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3133
         upper limit
    		 3.1824
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.396

    Secondary: Number of Participants Who Experienced an Adverse Event (AE)

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    End point title
    		 Number of Participants Who Experienced an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose: - Results in death; - Is life-threatening; - Requires inpatient hospitalization or prolongation of existing hospitalization; - Results in persistent disability/incapacity; - Is a congenital anomaly/birth defect. The safety analysis set included all randomized subjects who received 1 dose of etokimab or placebo.
    End point type
    Secondary
    End point timeframe
    From first dose to Week 24
    End point values
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W Etokimab 300 mg / 150 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W
    Number of subjects analysed
    60
    61
    59
    60
    60
    Units: subjects
        Any TEAEs
    38
    40
    41
    42
    43
        Serious TEAE
    1
    2
    3
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to Week 24
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 20 mg SC Q4W
    Reporting group description
    		 Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 600 mg / 300 mg SC Q4W
    Reporting group description
    		 Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q4W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.

    Reporting group title
    Etokimab 300 mg / 150 mg SC Q8W
    Reporting group description
    		 Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q8W for up to 16 weeks. At Weeks 4 and 12 participants received placebo.

    Serious adverse events
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W Etokimab 300 mg / 150 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 61 (3.28%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
    3 / 59 (5.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    Troponin I Increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hysterectomy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis Atopic
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    3 / 60 (5.00%)
    1 / 60 (1.67%)
    2 / 59 (3.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis Exfoliative Generalised
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint Instability
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema Herpeticum
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Etokimab 20 mg SC Q4W Etokimab 600 mg / 300 mg SC Q4W Etokimab 300 mg / 150 mg SC Q4W Etokimab 300 mg / 150 mg SC Q8W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 60 (40.00%)
    22 / 61 (36.07%)
    26 / 60 (43.33%)
    18 / 60 (30.00%)
    23 / 59 (38.98%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
         occurrences all number
    3
    2
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 61 (8.20%)
    1 / 60 (1.67%)
    3 / 60 (5.00%)
    3 / 59 (5.08%)
         occurrences all number
    9
    5
    2
    5
    4
    Dizziness
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    3 / 60 (5.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    3
    0
    3
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    11 / 60 (18.33%)
    12 / 61 (19.67%)
    9 / 60 (15.00%)
    8 / 60 (13.33%)
    6 / 59 (10.17%)
         occurrences all number
    20
    15
    11
    11
    12
    Eczema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
    5 / 60 (8.33%)
    3 / 60 (5.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    4
    6
    4
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
    1 / 59 (1.69%)
         occurrences all number
    3
    0
    1
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 61 (6.56%)
    6 / 60 (10.00%)
    5 / 60 (8.33%)
    5 / 59 (8.47%)
         occurrences all number
    7
    4
    7
    8
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 61 (4.92%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
    1 / 59 (1.69%)
         occurrences all number
    5
    3
    5
    4
    2
    Oral herpes
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
    3 / 59 (5.08%)
         occurrences all number
    0
    0
    1
    2
    4
    Impetigo
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    1
    0
    0
    0
    3
    Conjunctivitis
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    4
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2018
    Updates included: - Resolution of key comments and requests from respective Regulatory Agencies/Health Authorities; - Procedures were clarified; - Alignment with the Common Protocol Template; - Minor grammatical, editorial, formatting, and administrative changes not affecting the conduct of the study have been incorporated into this amendment for clarification and administrative purposes only.
    02 Jul 2019
    Updates to the statistical approach to data analysis included: - Secondary endpoints were reorganized; - Some previously secondary endpoints were reclassified as exploratory; - Some previously exploratory endpoints were reclassified as secondary; - Timepoints were clarified for some endpoints; - An interim analysis was introduced for analysis of efficacy data at Week 16 and safety data collected as of the date of the data cut-off.

    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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