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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2019-001888-75
    Trial protocol
    		 DE   FR   BE   BG   PL   IT  
    Global end of trial date
    26 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2024
    First version publication date
    02 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.06.SPR.118169
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03989349
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 17122
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Zahlerweg 10, ZUG, Switzerland, 6300
    Public contact
    Clinical Trial Information Desk, Galderma S.A., CTA.Coordinator@galderma.com
    Scientific contact
    Clinical Trial Information Desk, Galderma S.A., CTA.Coordinator@galderma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001624-PIP01-14
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the efficacy and safety of Nemolizumab (CD14152) after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis not adequately controlled with topical treatments.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jun 2019
    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
    Poland: 265
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Bulgaria: 79
    Country: Number of subjects enrolled
    Estonia: 14
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Germany: 107
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Georgia: 11
    Country: Number of subjects enrolled
    Singapore: 14
    Country: Number of subjects enrolled
    United States: 195
    Worldwide total number of subjects
    787
    EEA total number of subjects
    567
    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)
    132
    Adults (18-64 years)
    603
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 136 active sites in Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, and the United States from 27 June 2019 to 26 September 2022.

    Pre-assignment
    Screening details
    		 A total of 787 randomized 2:1 to receive either nemolizumab or placebo. At Week 16, 235 nemolizumab treated responders re-randomized to receive nemolizumab Q4W,nemolizumab Q8W,or placebo during Maintenance Period.85 subjects received placebo in Initial Treatment, responded to placebo at Week 16,re-assigned to placebo and continued with placebo Q4W.

    Period 1
    Period 1 title
    Initial Treatment(Day 1-Week 16 Predose)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Initial Treatment Period: Placebo
    Arm description
    		 Subjects received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Arm title
    		 Initial Treatment Period: Nemolizumab 30 mg
    Arm description
    		 Subjects received nemolizumab 30 milligrams (mg) via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    CD14152
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Number of subjects in period 1
    		Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Started
    265
    522
    Completed
    241
    470
    Not completed
    24
    52
         Consent withdrawn by subject
    15
    24
         Physician decision
    -
    1
         Adverse event, non-fatal
    4
    17
         Randomised but not treated
    2
    3
         Lost to follow-up
    1
    1
         Protocol deviation
    2
    3
         Lack of efficacy
    -
    3
    Period 2
    Period 2 title
    Maintenance Period (Week 16-Week 48)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance Period: Nemolizumab 30 mg Q4W to Q4W
    Arm description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    CD14152
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders at Week 16 received placebo, Q8W at Weeks 20, 28, 36, and 44 by a single SC injection during Maintenance Period.

    Arm title
    		 Nemolizumab 30 mg Q4W to Q8W
    Arm description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q8W at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders at Week 16 received nemolizumab 30 mg, Q8W at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.

    Arm title
    		 Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q4W
    Arm description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q8W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders at Week 16 received placebo, Q8W at Weeks 20, 28, 36, and 44 by a single SC injection during Maintenance Period.

    Arm title
    		 Placebo Q4W Re-assigned to Placebo Q4W
    Arm description
    		 Subjects who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received placebo, Q4W during Initial Treatment Period and were clinical responders at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Number of subjects in period 2 [1]
    		Maintenance Period: Nemolizumab 30 mg Q4W to Q4W Nemolizumab 30 mg Q4W to Q8W Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q4W Placebo Q4W Re-assigned to Placebo Q4W
    Started
    79
    78
    78
    85
    Completed
    65
    68
    65
    74
    Not completed
    14
    10
    13
    11
         Consent withdrawn by subject
    2
    3
    1
    4
         Physician decision
    1
    1
    -
    1
         Re-randomized/Re-assigned but not Treated
    1
    -
    1
    1
         Adverse event, non-fatal
    3
    2
    3
    2
         other
    4
    2
    2
    -
         Lost to follow-up
    1
    -
    3
    -
         Lack of efficacy
    2
    2
    3
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Initial Treatment Period. At Week 16, 272 nemolizumab-treated participants who were clinical responders were re-randomized to receive nemolizumab Q4W, nemolizumab Q8W, or placebo during Maintenance Period. 85 participants who received placebo in Initial Treatment Period and responded to placebo at Week 16, were re-assigned to placebo and continued to receive placebo Q4W in Maintenance Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Initial Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Reporting group title
    Initial Treatment Period: Nemolizumab 30 mg
    Reporting group description
    		 Subjects received nemolizumab 30 milligrams (mg) via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Reporting group values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg Total
    Number of subjects
    		 265 522 787
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 41 91 132
        Adults (18-64 years)
    		 209 394 603
        From 65-84 years
    		 15 37 52
    Gender categorical
    Units: Subjects
        Female
    		 136 270 406
        Male
    		 129 252 381
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 19 44 63
        Not Hispanic or Latino
    		 244 464 708
        Unknown or Not Reported
    		 2 14 16
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 18 35 53
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 20 25 45
        White
    		 227 458 685
        Unknown or Not Reported
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Initial Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Reporting group title
    Initial Treatment Period: Nemolizumab 30 mg
    Reporting group description
    		 Subjects received nemolizumab 30 milligrams (mg) via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
    Reporting group title
    Maintenance Period: Nemolizumab 30 mg Q4W to Q4W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Reporting group title
    Nemolizumab 30 mg Q4W to Q8W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q8W at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.

    Reporting group title
    Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q4W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q8W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Reporting group title
    Placebo Q4W Re-assigned to Placebo Q4W
    Reporting group description
    		 Subjects who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Primary: Percentage of Subjects With Investigator’s Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population

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    End point title
    		 Percentage of Subjects With Investigator’s Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population
    End point description
    IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data at Week 16 were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: Percentage of subjects
        number (not applicable)
    26.0
    37.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0006 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    12.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 19.8
    Notes
    [1] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Primary: Percentage of Subjects With Investigator’s Global Assessment (IGA) Success at Week 16: Severe Pruritus Population

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    End point title
    		 Percentage of Subjects With Investigator’s Global Assessment (IGA) Success at Week 16: Severe Pruritus Population
    End point description
    IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Subjects with missing data at Week 16 are considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    22.0
    36.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0008 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    14.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 24.3
    Notes
    [2] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Primary: Percentage of Subjects With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population

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    End point title
    		 Percentage of Subjects With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
    End point description
    EASI-75 was defined as >=75 percent (%) improvement in EASI from baseline to Week 16. EASI evaluates severity of subjects AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Subjects with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. The ITT population consisted of all randomised subjects.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    30.2
    42.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0006 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    12.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 20.3
    Notes
    [3] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Primary: Percentage of Subjects With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population

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    End point title
    		 Percentage of Subjects With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population
    End point description
    EASI-75 was defined as >=75 percent (%) improvement in EASI from baseline to Week 16. EASI evaluates severity of subjects AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Subjects with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    25.0
    41.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0004 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    16.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 6.6
         upper limit
    		 26
    Notes
    [4] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population

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    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    18.1
    41.0
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level. Subjects with missing data are considered non-responders.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    23.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 16.1
         upper limit
    		 30.3
    Notes
    [5] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).
    Statistical analysis title
    		 Statistical Analysis 2: MI-MAR Method
    Statistical analysis description
    Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption. The estimates are from 50 complete datasets by MI-MAR assumption.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    27.8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 21.2
         upper limit
    		 34.5
    Notes
    [6] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy is considered treatment failure. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    21.3
    48.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level. Subjects with missing data are considered non-responders.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    27.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 17.5
         upper limit
    		 36.6
    Notes
    [7] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).
    Statistical analysis title
    		 Statistical Analysis 2: MI-MAR Method
    Statistical analysis description
    Nemolizumab 30 mg versus Placebo using MI-MAR assumption. The estimates are from 50 complete datasets by MI-MAR assumption.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    33.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 24.5
         upper limit
    		 42.3
    Notes
    [8] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe].

    Secondary: Percentage of Subjects With <2 Points in Weekly Average PP NRS at Week 16: ITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subject with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    11.3
    28.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    17.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 10.9
         upper limit
    		 23.3
    Notes
    [9] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subject to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    8.5
    26.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    18.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 25.8
    Notes
    [10] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population

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    End point title
    		 Percentage of Subjects With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
    End point description
    The sleep disturbance NRS is a scale used by the subjects to report the degree of their sleep loss related to AD. Subjects were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    16.2
    33.5
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    17.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 10.8
         upper limit
    		 24.3
    Notes
    [11] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
    End point description
    The sleep disturbance NRS is a scale used by the subjects to report the degree of their sleep loss related to AD. Subjects were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    20.7
    42.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    21.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 12.5
         upper limit
    		 31.4
    Notes
    [12] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    5.3
    26.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    20.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 15.6
         upper limit
    		 26.1
    Notes
    [13] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    7.9
    30.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    22.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 15
         upper limit
    		 29.9
    Notes
    [14] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    2.6
    15.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    13.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 9
         upper limit
    		 17.4
    Notes
    [15] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    1.2
    11.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    9.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 5.5
         upper limit
    		 14.3
    Notes
    [16] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    1.9
    16.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [17]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    15.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 19.2
    Notes
    [17] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    3.0
    19.3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    16.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 10.5
         upper limit
    		 22.1
    Notes
    [18] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population

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    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. The ITT population consisted of all randomised subjects. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    265
    522
    Units: percentage of subjects
        number (not applicable)
    0.4
    6.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the endpoints were reported and continued when the test for preceding endpoint was statistically significant at two-sided 2.5% significance level.
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    787
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [19]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    6.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 9.1
    Notes
    [19] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe] and PP NRS [>=7, <7]).

    Secondary: Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale: Severe Pruritus Population

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    End point title
    		 Percentage of Subjects With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale: Severe Pruritus Population
    End point description
    The PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a subject received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Subjects with missing data were considered non-responders. Severe pruritus population consisted of all randomised subjects with a baseline PP NRS >=7. Data was planned to be collected and analysed for Initial Treatment Period.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects analysed
    164
    316
    Units: percentage of subjects
        number (not applicable)
    0.6
    8.5
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Initial Treatment Period: Placebo v Initial Treatment Period: Nemolizumab 30 mg
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 11.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period to Week 48
    Adverse event reporting additional description
    The safety population comprised all subjects who received at least 1 dose of study drug. One subject was re-randomized to Nemolizumab Q8W for Maintenance Period, but erroneously received Nemolizumb twice consecutively and thus counted in Nemolizumab 30 mg Q4W to Q4W for safety analysis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Initial Treatment Period: Nemolizumab 30 mg
    Reporting group description
    		 Subjects received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Reporting group title
    Initial Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.

    Reporting group title
    Maintenance Period: Nemolizumab 30 mg Q4W to Q4W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Reporting group title
    Maintenance Period: Nemolizumab 30 mg Q4W to Q8W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q8W at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.

    Reporting group title
    Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q8W
    Reporting group description
    		 Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q8W at Weeks 20, 28, 36, and 44 by a single SC injection during Maintenance Period.

    Reporting group title
    Maintenance Period: Placebo Q4W Re-assigned to Placebo Q4W
    Reporting group description
    		 Subjects who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as subjects with an IGA of 0 [clear] or 1 [almost clear] or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.

    Serious adverse events
    		 Initial Treatment Period: Nemolizumab 30 mg Initial Treatment Period: Placebo Maintenance Period: Nemolizumab 30 mg Q4W to Q4W Maintenance Period: Nemolizumab 30 mg Q4W to Q8W Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q8W Maintenance Period: Placebo Q4W Re-assigned to Placebo Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 519 (2.50%)
    3 / 263 (1.14%)
    6 / 79 (7.59%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
    1 / 84 (1.19%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychogenic tremor
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Injury, poisoning and procedural complications
    Comminuted fracture
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cyst
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 519 (0.00%)
    1 / 263 (0.38%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic colitis
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Inguinal hernia
         subjects affected / exposed
    0 / 519 (0.00%)
    1 / 263 (0.38%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 519 (0.58%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    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
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 519 (0.39%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 519 (0.00%)
    1 / 263 (0.38%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 519 (0.00%)
    1 / 263 (0.38%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 519 (0.00%)
    0 / 263 (0.00%)
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Herpes zoster
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Infected cyst
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Superinfection bacterial
         subjects affected / exposed
    1 / 519 (0.19%)
    0 / 263 (0.00%)
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Initial Treatment Period: Nemolizumab 30 mg Initial Treatment Period: Placebo Maintenance Period: Nemolizumab 30 mg Q4W to Q4W Maintenance Period: Nemolizumab 30 mg Q4W to Q8W Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q8W Maintenance Period: Placebo Q4W Re-assigned to Placebo Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 519 (13.68%)
    40 / 263 (15.21%)
    17 / 79 (21.52%)
    11 / 77 (14.29%)
    26 / 77 (33.77%)
    16 / 84 (19.05%)
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    34 / 519 (6.55%)
    15 / 263 (5.70%)
    6 / 79 (7.59%)
    3 / 77 (3.90%)
    6 / 77 (7.79%)
    5 / 84 (5.95%)
         occurrences all number
    42
    15
    7
    4
    7
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 519 (3.66%)
    12 / 263 (4.56%)
    7 / 79 (8.86%)
    3 / 77 (3.90%)
    5 / 77 (6.49%)
    6 / 84 (7.14%)
         occurrences all number
    24
    13
    12
    6
    6
    8
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 519 (1.16%)
    5 / 263 (1.90%)
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    5 / 77 (6.49%)
    2 / 84 (2.38%)
         occurrences all number
    6
    5
    1
    2
    5
    2
    COVID-19
         subjects affected / exposed
    14 / 519 (2.70%)
    8 / 263 (3.04%)
    3 / 79 (3.80%)
    4 / 77 (5.19%)
    13 / 77 (16.88%)
    6 / 84 (7.14%)
         occurrences all number
    14
    8
    3
    4
    13
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2019
    This substantial protocol amendment was required as it updated and clarified study drug information, systemic rescue therapy use, added sleep metrics to clarify secondary endpoints to be assessed based on the subject sleep diary, Added timepoints for PEF collection in subjects without a medical history of asthma, added information to support dose selection rationale, Updated the schedule of assessments to align with the eCRF, corrected and clarified the schedule of assessments, added study design rationale for full population and subpopulation of PP NRS ≥7 analyses, approved contraceptive methods for females to maximize pregnancy prevention in female subjects.
    27 Feb 2020
    This substantial protocol amendment was required as it updated inclusion criteria o clarify ‘true abstinence’ and remove single-barrier methods as effective forms of contraception. Also, it clarified steps for emergency breaking of the blind by the Investigator
    01 Jun 2020
    This amendment included update in study drug description, methods of contraception, exclusion criterion including clarification regarding asthma that was not well controlled, subjects with specified infections at baseline and subjects with COVID-19 infection were to be excluded, failure of dupilumab, history of malignancy to allow a shortened timeframe between treatment and study entry for subjects with certain previously treated malignancies and AESIs to include COVID-19
    04 Nov 2021
    This amendment updated and clarified administrative items from memo dated 06 May 2021, Clarified points related to inclusion criteria/exclusion criteria

    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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