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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    2021-002203-34
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Apr 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    M16-813
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03706040
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Abbvie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 800-633-9110, abbvieclinicaltrials@abbvie.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Dec 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
    Australia: 22
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    Japan: 32
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    United States: 78
    Worldwide total number of subjects
    172
    EEA total number of subjects
    0
    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)
    2
    Adults (18-64 years)
    149
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Adults and adolescents with moderate to severe atopic dermatitis (AD) with onset of symptoms at least 2 years before the Baseline visit were enrolled at 50 sites in the United States, Canada, Japan, and Australia. The study included a 16-week double-blind treatment period (Period A) followed by a 36-week double-blind treatment period (Period B).

    Pre-assignment
    Screening details
    Subjects were randomized in a 2:2:1 ratio to receive risankizumab 150 mg, 300 mg, or placebo with stratification by disease severity (Validated Investigator Global Assessment Scale for AD [vIGA-AD] moderate vs severe) and geographic region. At Week 16 subjects in the placebo group were re-randomized in a 1:1 ratio to risankizumab 150 mg or 300 mg.

    Period 1
    Period 1 title
    Period A (Week 0 - 16)
    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
    Placebo
    Arm description
    Participants randomized to receive placebo at Weeks 0 and 4 in Period A.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Baseline (Week 0) and Week 4.

    Arm title
    Risankizumab 150 mg
    Arm description
    Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Baseline (Week 0) and Week 4.

    Arm title
    Risankizumab 300 mg
    Arm description
    Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Baseline (Week 0) and Week 4.

    Number of subjects in period 1
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Started
    34
    69
    69
    Completed
    25
    61
    58
    Not completed
    9
    8
    11
         Consent withdrawn by subject
    3
    5
    4
         Adverse event, non-fatal
    3
    2
    1
         Other
    2
    -
    2
         Lost to follow-up
    1
    1
    4
    Period 2
    Period 2 title
    Period B (Week 16 - 52)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo / Risankizumab 150 mg
    Arm description
    Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Week 16, Week 28, and Week 40

    Arm title
    Placebo / Risankizumab 300 mg
    Arm description
    Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Week 16, Week 28, and Week 40

    Arm title
    Risankizumab 150 mg / Risankizumab 150 mg
    Arm description
    Participants initially randomized to receive 150 mg risankizumab SC in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Week 16, Week 28, and Week 40

    Arm title
    Risankizumab 300 mg / Risankizumab 300 mg
    Arm description
    Participants initially randomized to receive 300 mg risankizumab SC in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection (SC) at Week 16, Week 28, and Week 40

    Number of subjects in period 2
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Started
    13
    12
    61
    58
    Received Study Drug
    13
    11
    61
    57
    Completed
    5
    3
    33
    30
    Not completed
    8
    9
    28
    28
         Consent withdrawn by subject
    3
    2
    1
    10
         Adverse event, non-fatal
    1
    2
    3
    -
         Other
    4
    5
    23
    17
         Lost to follow-up
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants randomized to receive placebo at Weeks 0 and 4 in Period A.

    Reporting group title
    Risankizumab 150 mg
    Reporting group description
    Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.

    Reporting group title
    Risankizumab 300 mg
    Reporting group description
    Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.

    Reporting group values
    Placebo Risankizumab 150 mg Risankizumab 300 mg Total
    Number of subjects
    34 69 69 172
    Age categorical
    Units: Subjects
        < 18 years
    0 1 1 2
        18 - 39 years
    15 34 27 76
        40 - 64 years
    10 27 36 73
        ≥ 65 years
    9 7 5 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.5 ± 19.66 41.7 ± 15.12 43.8 ± 16.63 -
    Gender categorical
    Units: Subjects
        Female
    13 31 32 76
        Male
    21 38 37 96
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 8 6 14
        Not Hispanic or Latino
    34 61 63 158
    Race
    Units: Subjects
        White
    17 39 36 92
        Black or African American
    7 8 11 26
        Asian
    8 21 20 49
        Native Hawaiian or Other Pacific Islander
    1 0 1 2
        American Indian or Alaska Native
    0 1 1 2
        Multiple
    1 0 0 1
    Geographic Region
    Units: Subjects
        Japan
    6 13 13 32
        Rest of World
    28 56 56 140
    Disease Severity
    Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale: 0-Clear: No signs of AD; 1-Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2-Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3-Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4-Severe: Marked erythema, induration/papulation and/or lichenification
    Units: Subjects
        3 (Moderate)
    20 40 39 99
        4 (Severe)
    14 29 30 73
    Eczema Area and Severity Index (EASI) Score
    EASI measures the extent and severity of atopic eczema based on assessments of the 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 redness, thickness, scratching, and lichenification are assessed. The score for each region is calculated by multiplying the severity score by the area score, and adjusting for the proportion of the body region to the whole body. The EASI score is the sum of the scores for each region and ranges from 0 to 72 (worse disease).
    Units: score on a scale
        arithmetic mean (standard deviation)
    30.85 ± 12.345 31.06 ± 13.995 28.70 ± 11.247 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants randomized to receive placebo at Weeks 0 and 4 in Period A.

    Reporting group title
    Risankizumab 150 mg
    Reporting group description
    Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.

    Reporting group title
    Risankizumab 300 mg
    Reporting group description
    Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.
    Reporting group title
    Placebo / Risankizumab 150 mg
    Reporting group description
    Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Placebo / Risankizumab 300 mg
    Reporting group description
    Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Risankizumab 150 mg / Risankizumab 150 mg
    Reporting group description
    Participants initially randomized to receive 150 mg risankizumab SC in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Risankizumab 300 mg / Risankizumab 300 mg
    Reporting group description
    Participants initially randomized to receive 300 mg risankizumab SC in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Primary: Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75 Response) at Week 16

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    End point title
    Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75 Response) at Week 16
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusting for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [1]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    11.8 (0.9 to 22.6)
    24.6 (14.5 to 34.8)
    21.7 (12.0 to 31.5)
    Notes
    [1] - Intent-to-treat (ITT) population (all randomized participants)
    Statistical analysis title
    Primary Analysis of EASI-75 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.084 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    27.7
    Notes
    [2] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Primary Analysis of EASI-75 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.179 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    24.6
    Notes
    [3] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16

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    End point title
    Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
    End point description
    Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale: 0-Clear: No signs of AD; 1-Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2-Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3-Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4-Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [4]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    5.9 (0.0 to 13.8)
    14.5 (6.2 to 22.8)
    5.8 (0.3 to 11.3)
    Notes
    [4] - Intent-to-treat population
    Statistical analysis title
    Analysis of vIGA Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.129 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    8.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    20
    Notes
    [5] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of vIGA Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.994 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    -0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.4
         upper limit
    9.4
    Notes
    [6] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

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    End point title
    Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
    End point description
    Participants were asked to rate itch (pruritis) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The analysis was conducted in the intent-to-treat population with a Baseline Pruritus NRS of ≥ 4; Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis . "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    33 [7]
    66
    66
    Units: percentage of participants
        number (confidence interval 95%)
    0 (-99999 to 99999)
    13.6 (5.4 to 21.9)
    15.2 (6.5 to 23.8)
    Notes
    [7] - Intent-to-treat population with a Baseline Pruritus NRS of ≥ 4
    Statistical analysis title
    Analysis of Pruritus NRS Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    13.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.4
         upper limit
    22.1
    Notes
    [8] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of Pruritus NRS Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    15.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.6
         upper limit
    24
    Notes
    [9] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

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

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    End point title
    Percent Change From Baseline in EASI Score at Week 16
    End point description
    EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusted for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement. Missing data were handled using a mixed-effect model with repeated measurements (MMRM).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    17 [10]
    51 [11]
    43 [12]
    Units: percent change
        least squares mean (standard error)
    -28.54 ± 9.378
    -38.86 ± 5.989
    -45.39 ± 6.351
    Notes
    [10] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [11] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [12] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    Statistical analysis title
    Analysis of Change from Baseline in EASI
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.353 [13]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    Least Squares (LS) Mean Difference
    Point estimate
    -10.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.25
         upper limit
    11.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.073
    Notes
    [13] - Mixed effect model repeated measurement (MMRM) analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.
    Statistical analysis title
    Analysis of Change from Baseline in EASI
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.139 [14]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -16.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -39.24
         upper limit
    5.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.305
    Notes
    [14] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.

    Secondary: Percent Change From Baseline in EASI Score at Week 28 and Week 52

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    End point title
    Percent Change From Baseline in EASI Score at Week 28 and Week 52
    End point description
    EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling), scratching, and lichenification (lined skin, prurigo nodules). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement. LS means were calculated from an analysis of covariance (ANCOVA) model with Baseline, treatment and vIGA-AD categories in the model.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [15]
    5 [16]
    45 [17]
    43 [18]
    Units: percent change
    least squares mean (standard error)
        Week 28
    -58.60 ± 12.091
    -59.81 ± 14.956
    -62.44 ± 5.065
    -63.77 ± 5.051
        Week 52
    -31.39 ± 12.979
    -76.75 ± 14.199
    -67.47 ± 4.663
    -62.70 ± 4.875
    Notes
    [15] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [16] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [17] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    [18] - Intent-to-treat population with available data at each time point; N= 33 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [19]
    5 [20]
    45 [21]
    43 [22]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    37.5 (4.0 to 71.0)
    0 (-99999 to 99999)
    53.3 (38.8 to 67.9)
    41.9 (27.1 to 56.6)
        Week 52
    0 (-99999 to 99999)
    75.0 (32.6 to 100.0)
    43.2 (27.3 to 59.2)
    45.5 (28.5 to 62.4)
    Notes
    [19] - Intent-to-treat population with available data at each time point; N = 5 at Week 52
    [20] - Intent-to-treat population with available data at each time point; N = 4 at Week 52
    [21] - Intent-to-treat population with available data at each time point; N = 37 at Week 52
    [22] - Intent-to-treat population with available data at each time point; N = 33 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved an EASI 50 Response at Week 16

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    End point title
    Percentage of Participants Who Achieved an EASI 50 Response at Week 16
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusting for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score. NRI-C imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [23]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    29.4 (14.1 to 44.7)
    42.0 (30.4 to 53.7)
    34.8 (23.5 to 46.0)
    Notes
    [23] - Intent-to-treat population
    Statistical analysis title
    Analysis of EASI 50 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.171 [24]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    12.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.6
         upper limit
    31.4
    Notes
    [24] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of EASI 50 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.552 [25]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    5.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.1
         upper limit
    24.5
    Notes
    [25] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusting for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [26]
    5 [27]
    45 [28]
    43 [29]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    75.0 (45.0 to 100.0)
    80.0 (44.9 to 100.0)
    73.3 (60.4 to 86.3)
    74.4 (61.4 to 87.5)
        Week 52
    40.0 (0.0 to 82.9)
    75.0 (32.6 to 100.0)
    78.4 (65.1 to 91.6)
    72.7 (57.5 to 87.9)
    Notes
    [26] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [27] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [28] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    [29] - Intent-to-treat population with available data at each time point; N=33 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved an EASI 90 Response at Week 16

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    End point title
    Percentage of Participants Who Achieved an EASI 90 Response at Week 16
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusting for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score. NRI-C imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [30]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    2.9 (0.0 to 8.6)
    14.5 (6.2 to 22.8)
    8.7 (2.0 to 15.3)
    Notes
    [30] - Intent-to-treat population
    Statistical analysis title
    Analysis of EASI 90 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.022 [31]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    11.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.7
         upper limit
    21.6
    Notes
    [31] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of EASI 90 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.192 [32]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    5.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    14.4
    Notes
    [32] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
    End point description
    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, adjusting for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. EASI 90 response is defined as at least a 90% reduction from Baseline in EASI score. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [33]
    5 [34]
    45 [35]
    43 [36]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    25.0 (0.0 to 55.0)
    0 (-99999 to 99999)
    26.7 (13.7 to 39.6)
    27.9 (14.5 to 41.3)
        Week 52
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    24.3 (10.5 to 38.1)
    18.2 (5.0 to 31.3)
    Notes
    [33] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [34] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [35] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    [36] - Intent-to-treat population with available data at each time point; N=33 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52
    End point description
    Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale: 0-Clear: No signs of AD; 1-Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2-Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3-Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4-Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [37]
    5 [38]
    45 [39]
    43 [40]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    22.2 (10.1 to 34.4)
    25.6 (12.5 to 38.6)
        Week 52
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    24.3 (10.5 to 38.1)
    21.2 (7.3 to 35.2)
    Notes
    [37] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [38] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [39] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    [40] - Intent-to-treat population with available data at each time point; N=33 at Week 52
    No statistical analyses for this end point

    Secondary: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16

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    End point title
    Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
    End point description
    Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement. Missing data were handled using a mixed-effect model with repeated measurements (MMRM).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    17 [41]
    51 [42]
    43 [43]
    Units: percentage of body surface area
        least squares mean (standard error)
    -7.41 ± 3.813
    -13.64 ± 2.429
    -13.27 ± 2.569
    Notes
    [41] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [42] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [43] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    Statistical analysis title
    Analysis of Change from Baseline in BSA
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.169 [44]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -6.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.15
         upper limit
    2.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.506
    Notes
    [44] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.
    Statistical analysis title
    Analysis of Change from Baseline in BSA
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.204 [45]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -5.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.94
         upper limit
    3.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.589
    Notes
    [45] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.

    Secondary: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Weeks 28 and 52

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    End point title
    Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Weeks 28 and 52
    End point description
    Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement. LS means and standard errors were calculated from ANCOVA with Baseline, treatment and stratrum (Baseline vIGA-AD categories) in the model.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    8 [46]
    5 [47]
    45 [48]
    43 [49]
    Units: percentage of body surface area
    least squares mean (standard error)
        Week 28
    -20.07 ± 5.843
    -11.90 ± 7.294
    -23.23 ± 2.438
    -23.22 ± 2.443
        Week 52
    -0.86 ± 6.525
    -30.23 ± 7.316
    -29.26 ± 2.400
    -22.14 ± 2.510
    Notes
    [46] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [47] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [48] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    [49] - Intent-to-treat population with available data at each time point; N=33 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50 Response) at Week 16

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    End point title
    Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50 Response) 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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [50]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    18.0 (5.0 to 31.1)
    24.6 (14.5 to 34.8)
    13.0 (5.1 to 21.0)
    Notes
    [50] - Intent-to-treat population
    Statistical analysis title
    Analysis of SCORAD 50 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.422 [51]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    6.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.7
         upper limit
    23.1
    Notes
    [51] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of SCORAD 50 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.505 [52]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    -5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.3
         upper limit
    10
    Notes
    [52] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 28 and 52

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    End point title
    Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 28 and 52
    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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [53]
    5 [54]
    46 [55]
    43 [56]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    44.4 (12.0 to 76.9)
    20.0 (0.0 to 55.1)
    47.8 (33.4 to 62.3)
    37.2 (22.8 to 51.7)
        Week 52
    0 (-99999 to 99999)
    50.0 (1.0 to 99.0)
    52.6 (36.8 to 68.5)
    35.1 (19.8 to 50.5)
    Notes
    [53] - Intent-to-treat population with available data at each time point; N=6 at Week 52
    [54] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [55] - Intent-to-treat population with available data at each time point; N=38 at Week 52
    [56] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16

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    End point title
    Percentage of Participants Who Achieved a SCORAD 75 Response 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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [57]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    0 (-99999 to 99999)
    10.1 (3.0 to 17.3)
    2.9 (0.0 to 6.9)
    Notes
    [57] - Intent-to-treat population
    Statistical analysis title
    Analysis of SCORAD 75 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005 [58]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    10.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3
         upper limit
    17.3
    Notes
    [58] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of SCORAD 75 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.151 [59]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    2.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    6.8
    Notes
    [59] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 28 and 52

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    End point title
    Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 28 and 52
    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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [60]
    5 [61]
    46 [62]
    43 [63]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    11.1 (0.0 to 31.6)
    0 (-99999 to 99999)
    23.9 (11.6 to 36.2)
    11.6 (2.0 to 21.2)
        Week 52
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    21.1 (8.1 to 34.0)
    13.5 (2.5 to 24.5)
    Notes
    [60] - Intent-to-treat population with available data at each time point; N=6 at Week 52
    [61] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [62] - Intent-to-treat population with available data at each time point; N=38 at Week 52
    [63] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16

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    End point title
    Percentage of Participants Who Achieved a SCORAD 90 Response 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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [64]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    0 (-99999 to 99999)
    5.8 (0.3 to 11.3)
    1.4 (0.0 to 4.3)
    Notes
    [64] - Intent-to-treat population
    Statistical analysis title
    Analysis of SCORAD 90 Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.035 [65]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    5.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.4
         upper limit
    11.3
    Notes
    [65] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of SCORAD 90 Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.311 [66]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    4.4
    Notes
    [66] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 28 and 52

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    End point title
    Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 28 and 52
    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 a percentage of the whole body (0-100%). 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 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score. "99999" indicates values that could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [67]
    5 [68]
    46 [69]
    43 [70]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    6.5 (0.0 to 13.7)
    4.7 (0.0 to 10.9)
        Week 52
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    15.8 (4.2 to 27.4)
    10.8 (0.8 to 20.8)
    Notes
    [67] - Intent-to-treat population with available data at each time point; N=6 at Week 52
    [68] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [69] - Intent-to-treat population with available data at each time point; N=38 at Week 52
    [70] - Intent-to-treat population with available data at each time point; N=37 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16

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    End point title
    Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" 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 score of 0 or 1 means that the disease has no effect at all. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    34 [71]
    69
    69
    Units: percentage of participants
        number (confidence interval 95%)
    9.0 (0.0 to 18.8)
    8.7 (2.0 to 15.3)
    5.8 (0.3 to 11.3)
    Notes
    [71] - Intent-to-treat population
    Statistical analysis title
    Analysis of DLQI Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.965 [72]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    11.5
    Notes
    [72] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of DLQI Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.583 [73]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    -3.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.3
         upper limit
    8.1
    Notes
    [73] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
    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 score of 0 or 1 means that the disease has no effect at all.
    End point type
    Secondary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [74]
    5 [75]
    49 [76]
    44 [77]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    22.2 (0.0 to 49.4)
    20.0 (0.0 to 55.1)
    16.3 (6.0 to 26.7)
    13.6 (3.5 to 23.8)
        Week 52
    20.0 (0.0 to 55.1)
    25.0 (0.0 to 67.4)
    13.9 (2.6 to 25.2)
    15.6 (3.0 to 28.2)
    Notes
    [74] - ITT population with available data at each time point; N=5 at Week 52
    [75] - ITT population with available data at each time point; N=4 at Week 52
    [76] - ITT population with available data at each time point; N=36 at Week 52
    [77] - ITT population with available data at each time point; N=32 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16

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    End point title
    Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
    End point description
    The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. In this study, the CDLQI was administered to participants who were < 16 years old at Baseline. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID- 19 (NRI-C) was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    0 [78]
    1 [79]
    1 [80]
    Units: percentage of participants
        number (not applicable)
    0
    0
    Notes
    [78] - Intent-to-treat population < 16 years old at the Baseline visit
    [79] - Intent-to-treat population < 16 years old at the Baseline visit
    [80] - Intent-to-treat population < 16 years old at the Baseline visit
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
    End point description
    The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. In this study, the CDLQI was administered to participants who were < 16 years old at Baseline. There were no participants with available CDLQI results at Week 52, so only Week 28 results are presented.
    End point type
    Secondary
    End point timeframe
    Week 28 and Week 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    0 [81]
    0 [82]
    1 [83]
    0 [84]
    Units: percentage of participants
        number (not applicable)
    0
    Notes
    [81] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [82] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [83] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [84] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline to Week 16 Among Those with a DLQI ≥ 4 at Baseline

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    End point title
    Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline to Week 16 Among Those with a DLQI ≥ 4 at Baseline
    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 change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID). Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    32 [85]
    64
    64
    Units: percentage of participants
        number (confidence interval 95%)
    25.6 (10.3 to 41.0)
    31.3 (19.9 to 42.6)
    37.5 (25.6 to 49.4)
    Notes
    [85] - Intent-to-treat population with a Baseline DLQI ≥ 4
    Statistical analysis title
    Analysis of DLQI MCID Response
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.539 [86]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    5.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13
         upper limit
    24.9
    Notes
    [86] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).
    Statistical analysis title
    Analysis of DLQI MCID Response
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.213 [87]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted Difference
    Point estimate
    12.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7
         upper limit
    31.5
    Notes
    [87] - Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]).

    Secondary: Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline to Week 28 and Week 52 Among Those with a DLQI ≥ 4 at Baseline

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    End point title
    Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline to Week 28 and Week 52 Among Those with a DLQI ≥ 4 at Baseline
    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 change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [88]
    5 [89]
    45 [90]
    51 [91]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    77.8 (50.6 to 100.0)
    40.0 (0.0 to 82.9)
    66.7 (52.9 to 80.4)
    68.3 (54.0 to 82.5)
        Week 52
    60.0 (17.1 to 100.0)
    50.0 (1.0 to 99.0)
    63.6 (47.2 to 80.0)
    66.7 (49.8 to 83.5)
    Notes
    [88] - Intent-to-treat population with a Baseline DLQI of ≥ 4; N=5 at Week 52
    [89] - Intent-to-treat population with a Baseline DLQI of ≥ 4; N=4 at Week 52
    [90] - Intent-to-treat population with a Baseline DLQI of ≥ 4; N=33 at Week 52
    [91] - Intent-to-treat population with a Baseline DLQI of ≥ 4; N=30 at Week 52
    No statistical analyses for this end point

    Secondary: Change From Baseline in DLQI Score at Week 16

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    End point title
    Change From Baseline in 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. Missing data were handled using a mixed-effect model with repeated measurements (MMRM).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    17 [92]
    49 [93]
    41 [94]
    Units: scores on a scale
        least squares mean (standard error)
    -3.4 ± 1.55
    -3.4 ± 0.95
    -4.4 ± 1.03
    Notes
    [92] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [93] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [94] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    Statistical analysis title
    Analysis of Change from Baseline in DLQI
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.988 [95]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.82
    Notes
    [95] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.
    Statistical analysis title
    Analysis of Change from Baseline in DLQI
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.594 [96]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.7
         upper limit
    2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.86
    Notes
    [96] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.

    Secondary: Change From Baseline in DLQI Score at Weeks 28 and 52

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    End point title
    Change From Baseline in DLQI Score at Weeks 28 and 52
    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. LS means and standard errors were calculated from an ANCOVA model with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [97]
    5 [98]
    48 [99]
    43 [100]
    Units: scores on a scale
    least squares mean (standard error)
        Week 28
    -8.0 ± 2.06
    -5.3 ± 2.69
    -7.1 ± 0.87
    -7.3 ± 0.93
        Week 52
    -4.5 ± 2.99
    -5.0 ± 3.30
    -7.7 ± 1.11
    -6.5 ± 1.18
    Notes
    [97] - ITT population with available data at each time point; N=5 at Week 52
    [98] - ITT population with available data at each time point; N=4 at Week 52
    [99] - ITT population with available data at each time point; N=36 at Week 52
    [100] - ITT population with available data at each time point; N=32 at Week 52
    No statistical analyses for this end point

    Secondary: Change From Baseline in CDLQI Score at Week 16

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    End point title
    Change From Baseline in CDLQI Score at Week 16
    End point description
    The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement. In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit. Missing data were handled using a mixed-effect model with repeated measurements (MMRM).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    0 [101]
    1 [102]
    0 [103]
    Units: scores on a scale
        least squares mean (standard error)
    ±
    -2.0 ± 0.00
    ±
    Notes
    [101] - ITT population < 16 years old; No participants in this group were < 16 years old at Baseline
    [102] - ITT population < 16 years old; Baseline and Week 16 data contributed to the repeated measures model.
    [103] - ITT population < 16 years old; No participants in this group had available postbaseline CDLQI values
    No statistical analyses for this end point

    Secondary: Change From Baseline in CDLQI Score at Week 28 and Week 52

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    End point title
    Change From Baseline in CDLQI Score at Week 28 and Week 52
    End point description
    The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement. In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit. There were no participants with available CDLQI results at Week 52, so only Week 28 results are presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    0 [104]
    0 [105]
    1 [106]
    0 [107]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    1.0 ± 0.00
    ±
    Notes
    [104] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [105] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [106] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    [107] - Intent-to-treat population < 16 years old at the Baseline visit with available data
    No statistical analyses for this end point

    Secondary: Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16

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    End point title
    Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
    End point description
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement. Missing data were handled using a mixed-effect model with repeated measurements (MMRM).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Risankizumab 150 mg Risankizumab 300 mg
    Number of subjects analysed
    17 [108]
    45 [109]
    39 [110]
    Units: scores on a scale
        least squares mean (standard error)
    -0.098 ± 0.5110
    -1.416 ± 0.3408
    -1.746 ± 0.3619
    Notes
    [108] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [109] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    [110] - ITT population; non-missing Baseline and Week 16 data contributed to the repeated measures model.
    Statistical analysis title
    Analysis of Change from Baseline in Pruritus NRS
    Comparison groups
    Placebo v Risankizumab 150 mg
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.033 [111]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -1.318
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.531
         upper limit
    -0.105
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6137
    Notes
    [111] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.
    Statistical analysis title
    Analysis of Change from Baseline in Pruritus NRS
    Comparison groups
    Placebo v Risankizumab 300 mg
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009 [112]
    Method
    Mixed Effect Model Repeated Measurement
    Parameter type
    LS Mean Difference
    Point estimate
    -1.648
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.885
         upper limit
    -0.411
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.626
    Notes
    [112] - MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.

    Secondary: Change From Baseline in Worst Pruritus NRS at Weeks 28 and 52

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    End point title
    Change From Baseline in Worst Pruritus NRS at Weeks 28 and 52
    End point description
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement. LS means and standard errors were calculated from an ANCOVA with Baseline, treatment and stratrum (Baseline vIGA-AD categories) in the model.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [113]
    5 [114]
    50 [115]
    44 [116]
    Units: scores on a scale
    least squares mean (standard error)
        Week 28
    -2.685 ± 0.9303
    -3.182 ± 1.2347
    -2.474 ± 0.3887
    -2.684 ± 0.4179
        Week 52
    -2.668 ± 1.2153
    -4.012 ± 1.3907
    -2.936 ± 0.4567
    -2.454 ± 0.4957
    Notes
    [113] - Intent-to-treat population with available data at each time point; N=5 at Week 52
    [114] - Intent-to-treat population with available data at each time point; N=4 at Week 52
    [115] - Intent-to-treat population with available data at each time point; N=36 at Week 52
    [116] - Intent-to-treat population with available data at each time point; N=32 at Week 52
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus NRS From Baseline to Week 28 and Week 52

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    End point title
    Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus NRS From Baseline to Week 28 and Week 52
    End point description
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo / Risankizumab 150 mg Placebo / Risankizumab 300 mg Risankizumab 150 mg / Risankizumab 150 mg Risankizumab 300 mg / Risankizumab 300 mg
    Number of subjects analysed
    9 [117]
    5 [118]
    48 [119]
    43 [120]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 28
    22.2 (0.0 to 49.4)
    20.0 (0.0 to 55.1)
    31.3 (18.1 to 44.4)
    39.5 (24.9 to 54.1)
        Week 52
    20.0 (0.0 to 55.1)
    25.0 (0.0 to 67.4)
    38.2 (21.9 to 54.6)
    28.1 (12.5 to 43.7)
    Notes
    [117] - ITT population with Baseline Pruritus NRS ≥ 4 and available data at each time point; N=5 at Week 52
    [118] - ITT population with Baseline Pruritus NRS ≥ 4 and available data at each time point; N=4 at Week 52
    [119] - ITT population with Baseline Pruritus NRS ≥ 4 and available data at each time point; N=34 at Week 52
    [120] - ITT population with Baseline Pruritus NRS ≥ 4 and available data at each time point; N=32 at Week 52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Period A: Placebo
    Reporting group description
    Participants received placebo by subcutaneous injection at Week 0 and Week 4 in Period A.

    Reporting group title
    Period A: Risankizumab 150 mg
    Reporting group description
    Participants received 150 mg risankizumab SC at Week 0 and Week 4 in Period A.

    Reporting group title
    Period A: Risankizumab 300 mg
    Reporting group description
    Participants received 300 mg risankizumab SC at Week 0 and Week 4 in Period A.

    Reporting group title
    Period B: Placebo / Risankizumab 150 mg
    Reporting group description
    Participants initially randomized to placebo were re-randomized at Week 16 and received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Period B: Placebo / Risankizumab 300 mg
    Reporting group description
    Participants initially randomized to placebo were re-randomized at Week 16 and received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Period B: Risankizumab 150 mg / Risankizumab 150 mg
    Reporting group description
    Participants initially randomized to 150 mg risankizumab in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Reporting group title
    Period B: Risankizumab 300 mg / Risankizumab 300 mg
    Reporting group description
    Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.

    Serious adverse events
    Period A: Placebo Period A: Risankizumab 150 mg Period A: Risankizumab 300 mg Period B: Placebo / Risankizumab 150 mg Period B: Placebo / Risankizumab 300 mg Period B: Risankizumab 150 mg / Risankizumab 150 mg Period B: Risankizumab 300 mg / Risankizumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    2 / 61 (3.28%)
    3 / 57 (5.26%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CERVIX CARCINOMA STAGE I
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FRACTURED COCCYX
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SPINAL FRACTURE
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ARRHYTHMIA
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 61 (1.64%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    AMAUROSIS FUGAX
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    DERMATITIS ATOPIC
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    CELLULITIS
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 61 (1.64%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Period A: Placebo Period A: Risankizumab 150 mg Period A: Risankizumab 300 mg Period B: Placebo / Risankizumab 150 mg Period B: Placebo / Risankizumab 300 mg Period B: Risankizumab 150 mg / Risankizumab 150 mg Period B: Risankizumab 300 mg / Risankizumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 34 (50.00%)
    25 / 69 (36.23%)
    25 / 69 (36.23%)
    6 / 13 (46.15%)
    5 / 11 (45.45%)
    13 / 61 (21.31%)
    10 / 57 (17.54%)
    Investigations
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    1 / 61 (1.64%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    BLOOD THYROID STIMULATING HORMONE INCREASED
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 69 (0.00%)
    3 / 69 (4.35%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 61 (1.64%)
    1 / 57 (1.75%)
         occurrences all number
    3
    0
    3
    0
    0
    1
    1
    Cardiac disorders
    BUNDLE BRANCH BLOCK RIGHT
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Surgical and medical procedures
    WISDOM TEETH REMOVAL
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    DIZZINESS POSTURAL
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    LEUKOPENIA
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 61 (1.64%)
    0 / 57 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    General disorders and administration site conditions
    OEDEMA PERIPHERAL
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    DENTAL CARIES
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    TOOTHACHE
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    1 / 69 (1.45%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    Reproductive system and breast disorders
    AMENORRHOEA
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    DERMATITIS ATOPIC
         subjects affected / exposed
    7 / 34 (20.59%)
    19 / 69 (27.54%)
    16 / 69 (23.19%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
    7 / 61 (11.48%)
    5 / 57 (8.77%)
         occurrences all number
    7
    19
    16
    2
    1
    7
    5
    HYPERTROPHIC SCAR
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    PRURITUS
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 69 (2.90%)
    5 / 69 (7.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    2 / 61 (3.28%)
    0 / 57 (0.00%)
         occurrences all number
    2
    2
    5
    0
    0
    2
    0
    URTICARIA
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    2 / 69 (2.90%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    0
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 34 (0.00%)
    4 / 69 (5.80%)
    4 / 69 (5.80%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    4 / 61 (6.56%)
    3 / 57 (5.26%)
         occurrences all number
    0
    6
    4
    0
    0
    4
    4
    SKIN INFECTION
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 69 (1.45%)
    1 / 69 (1.45%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    TONSILLITIS
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    TOOTH INFECTION
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 61 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 69 (1.45%)
    3 / 69 (4.35%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 61 (1.64%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    3
    0
    0
    1
    1
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 69 (0.00%)
    0 / 69 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 61 (0.00%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2018
    The purpose of this Amendment was to: - Modify eligibility criterion #6 to add specific AD diagnosis criteria. - Add new eligibility criterion (new #10) with minimum daily worst pruritus criterion. - Update Areas of Safety Interest table to correct administrative inconsistencies. - Clarify requirements for obtaining samples in the event of a suspected systemic hypersensitivity reaction. - Clarify wording regarding post-dosing hypersensitivity monitoring.
    13 Feb 2019
    The purpose of this Amendment was to: - Update Protocol to align language around requiring a confirmed diagnosis of AD by a dermatologist for participation in the study with the eligibility criteria. - Update Background and Rationale to remove asthma from the list of indications that risankizumab is being developed. - Update data reported across Phase 3 psoriasis clinical studies in Benefits and Risks to Subjects. - Update Additional Endpoints to add detail around when variables will be analyzed and added proportion of subjects achieving EASI 100 and proportion of subjects achieving vIGA-AD of "0" with a reduction from Baseline of ≥ 2 points to the list of endpoints. - Update Overall Study Design and Plan to add detail to clarify the process around the number of subjects allowed to be screened, randomized, and enrolled in the study. - Update Eligibility Criterion 1 to clarify the process for obtaining adolescent subject assent and the need to consent in this study for adolescent subjects who become of legal age during the study. - Update Eligibility Criteria to add "and functionally able to read and understand study questionnaires" to eligibility criterion 2. - Update Withdrawal of Subjects and Discontinuation of Study regarding subject discontinuation criteria due to the occurrence of hepatic test abnormalities. - Update Complaints and Adverse Events to add detail around SAE reporting, add detail to definitions of AE severity, asthma-related AE reporting, and update the wording around risks. - Update Operations Manual to add the following: -- Hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) (if locally required) every 12 weeks. --adult waist circumference measurement at the Week 52 visit. -- text around the available supplemental asthma CRF. --detail that study drug administration instruction for risankizumab pre-filled syringes will be provided for use by site staff. --Additional clarifications and alignments to the Protocol.
    29 Jul 2019
    The purpose of this Amendment is to update the following: - Remove all mention of actigraphy from the Protocol since the study will no longer include actigraphy assessments. - Add Safety Grading Definitions to align with the updated risankizumab protocol standards. - Add local label guidance on contraception and live vaccination language to align with the updated risankizumab protocol standards. - Remove mention of the Statistical Analysis Plan – Supplemental (SAP-S) since complete and specific details of the statistical analysis will be added to the SAP and the SAP-S is no longer needed.
    13 Oct 2020
    The purpose of this version is to incorporate necessary protocol modifications due to the COVID-19 pandemic as follows: - Included information on the re-evaluation of the benefit and risk to subjects participating in the study. There is no anticipated additional risk to subjects. - Added instructions to refer to Operations Manual for necessary changes to activities or procedures. - Provided instructions in the event of temporary study drug interruption/halt due to COVID-19 and that in the event the subject cannot complete an onsite visit, administration of study drug at the subject's house is to be performed by study staff if feasible and permitted by local regulations. - Clarified that protocol deviations may include modifications due to COVID-19. Added NRI-C to incorporate handling of missing data due to COVID-19 as the primary approach and NRI-NC as sensitivity analysis. - Added that remote monitoring may be employed as needed. - Added reference to Operations Manual for allowed modification. - Operations Manual updated to include details on how to perform specific activities/procedures that may be impacted by changes in global/local regulations due to the pandemic.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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