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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
    		 2019-001887-31
    Trial protocol
    		 LV   GB   DE   LT   NL   AT   CZ   PL  
    Global end of trial date
    11 Aug 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.118161
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03985943
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 117122
    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
    11 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 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 (AD) 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 regulation.
    Background therapy
    		 Subjects received topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) as 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
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 190
    Country: Number of subjects enrolled
    Spain: 46
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Austria: 29
    Country: Number of subjects enrolled
    Czechia: 64
    Country: Number of subjects enrolled
    Germany: 90
    Country: Number of subjects enrolled
    Latvia: 28
    Country: Number of subjects enrolled
    Lithuania: 10
    Country: Number of subjects enrolled
    Australia: 54
    Country: Number of subjects enrolled
    Canada: 102
    Country: Number of subjects enrolled
    New Zealand: 13
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 83
    Country: Number of subjects enrolled
    United States: 209
    Worldwide total number of subjects
    941
    EEA total number of subjects
    464
    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)
    134
    Adults (18-64 years)
    768
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 177 active sites in Australia, Austria, Canada, Czech Republic, Germany, Great Britain, Korea, Latvia, Lithuania, Netherlands, New Zealand, Poland, Spain and the United States from 27 June 2019 to 11 August 2022.

    Pre-assignment
    Screening details
    		 Total of 941 randomized 2:1 to receive either nemolizumab or placebo. At Week 16, 272 nemolizumab responders re-randomized to receive nemolizumab Q4W,nemolizumab Q8W,or placebo during Maintenance Period. 100 subjects received placebo in Initial Treatment, responded to placebo at Week 16, re-assigned to placebo and continued to receive 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
    Nemolizumab matched Placebo

    Arm title
    		 Initial Treatment Period: Nemolizumab 30 mg
    Arm 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.
    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
    Nemolizumab 30 mg via 2 SC injections on Day 1 followed by single SC injection.

    Number of subjects in period 1
    		Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg
    Started
    321
    620
    Treated
    321
    620
    Completed
    296
    560
    Not completed
    25
    60
         Physician decision
    -
    1
         Subjects request
    11
    25
         Adverse event, non-fatal
    9
    9
         Randomized but not treated
    -
    4
         Pregnancy
    -
    2
         Lost to follow-up
    -
    10
         Lack of efficacy
    2
    5
         Protocol deviation
    3
    4
    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, every 4 weeks (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
    Nemolizumab 30 mg

    Arm title
    		 Maintenance Period: 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
    CD14152
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Nemolizumab 30 mg

    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, 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
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Nemolizumab matched Placebo

    Arm title
    		 Maintenance Period: 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
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Nemolizumab matched Placebo

    Number of subjects in period 2 [1]
    		Maintenance Period: Nemolizumab 30 mg Q4W to Q4W Maintenance Period: Nemolizumab 30 mg Q4W to Q8W Maintenance Period: Nemolizumab 30 mg Q4W to Placebo Q4W Maintenance Period: Placebo Q4W Re-assigned to Placebo Q4W
    Started
    90
    91
    91
    100
    Completed
    76
    79
    69
    82
    Not completed
    14
    12
    22
    18
         Consent withdrawn by subject
    6
    4
    5
    9
         Physician decision
    2
    1
    1
    2
         Adverse event, non-fatal
    1
    3
    1
    1
         Not specified
    -
    -
    1
    1
         Lost to follow-up
    -
    1
    1
    1
         Lack of efficacy
    4
    3
    12
    4
         Protocol deviation
    1
    -
    1
    -
    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: Subjects who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders at Week 16 were rerandomized during Maintenance Period. Subjects who received placebo, Q4W during Initial Treatment Period and were clinical responders at Week 16, were re-assigned during 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 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
    		 321 620 941
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.3 ( 15.61 ) 33.5 ( 15.93 ) -
    Gender categorical
    Units: Subjects
        Female
    		 144 297 441
        Male
    		 177 323 500
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 32 64 96
        Not Hispanic or Latino
    		 288 552 840
        Unknown or Not Reported
    		 1 4 5
    Race
    Units: Subjects
        Asian
    		 51 117 168
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 18 36 54
        White
    		 244 451 695
        More than one race
    		 4 10 14
        Unknown or Not Reported
    		 1 3 4
        American Indian or Alaska Native
    		 3 2 5

    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 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, every 4 weeks (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 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, 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: 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.

    Subject analysis set title
    Initial Treatment Period: Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set 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.

    Subject analysis set title
    Initial Treatment Period: Nemolizumab 30 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set 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.

    Primary: Percentage of Subjects With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population

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    End point title
    		 Percentage of Subjects With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    24.6
    35.6
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0003 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    11.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 4.7
         upper limit
    		 18.3
    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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Severe Pruritus Population

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    End point title
    		 Percentage of Subjects With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    21.4
    35.5
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    14.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 6.1
         upper limit
    		 22.5
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    29.0
    43.5
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    14.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 7.8
         upper limit
    		 22
    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. 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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    23.8
    41.6
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    18.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 9.6
         upper limit
    		 26.6
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    17.8
    42.7
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    24.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 18.4
         upper limit
    		 31.5
    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
    		 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: Nemolizumab 30 mg v Initial Treatment Period: Placebo
    Number of subjects included in analysis
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    28.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 22
         upper limit
    		 34.3
    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

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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: 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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    18.6
    46.1
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    27.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 19.4
         upper limit
    		 35.7
    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
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    32.1
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 24.4
         upper limit
    		 39.8
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    11.2
    30.6
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    19.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 13.7
         upper limit
    		 25.2
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    7.6
    27.8
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    20.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 26.8
    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.
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    19.9
    37.9
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    17.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 24.5
    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.
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    22.4
    42.1
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 11.2
         upper limit
    		 28.2
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    6.5
    27.4
    Statistical analysis title
    		 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
    941
    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
    		 15.8
         upper limit
    		 26
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    7.1
    28.3
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    21.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 14.8
         upper limit
    		 27.6
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    3.7
    16
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    12.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 8.2
         upper limit
    		 16.3
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    2.9
    12.6
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    9.7
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 5.2
         upper limit
    		 14.2
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    3.1
    17.7
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [17]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    14.6
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 10.6
         upper limit
    		 18.7
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    3.8
    20.7
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    16.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 22.3
    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
    321
    620
    Units: percentage of subjects
        number (not applicable)
    1.2
    4.5
    Statistical analysis title
    		 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
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0064 [19]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    3.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 5.8
    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
    210
    406
    Units: percentage of subjects
        number (not applicable)
    1.9
    6.2
    Statistical analysis title
    		 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
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0177 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata-adjusted percentage difference
    Point estimate
    4.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 7.7
    Notes
    [20] - Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomised stratification variables (IGA severity [3=moderate, 4=severe]).

    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 three times consecutively and thus counted in Nemolizumab 30 mg Q4W to Q4W for safety analysis.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    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 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 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 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 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.

    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 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: Placebo Initial Treatment Period: Nemolizumab 30 mg 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
    4 / 321 (1.25%)
    6 / 616 (0.97%)
    4 / 91 (4.40%)
    3 / 90 (3.33%)
    2 / 91 (2.20%)
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmablastic lymphoma
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 100 (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
    Salivary gland cancer
         subjects affected / exposed
    0 / 321 (0.00%)
    1 / 616 (0.16%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Uterine leiomyoma
         subjects affected / exposed
    0 / 321 (0.00%)
    1 / 616 (0.16%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 100 (1.00%)
         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
    Splenic injury
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 321 (0.00%)
    1 / 616 (0.16%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 321 (0.93%)
    2 / 616 (0.32%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 2
    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
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 321 (0.00%)
    1 / 616 (0.16%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 100 (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
    Musculoskeletal and connective tissue disorders
    Dupuytren's contracture
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    1 / 91 (1.10%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Periarthiritis
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    1 / 91 (1.10%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    1 / 91 (1.10%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    COVID-19
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    1 / 91 (1.10%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 321 (0.31%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 100 (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
    Cellulitis
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 321 (0.00%)
    0 / 616 (0.00%)
    0 / 91 (0.00%)
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 100 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Initial Treatment Period: Placebo Initial Treatment Period: Nemolizumab 30 mg 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
    67 / 321 (20.87%)
    144 / 616 (23.38%)
    27 / 91 (29.67%)
    28 / 90 (31.11%)
    33 / 91 (36.26%)
    35 / 100 (35.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 321 (3.43%)
    28 / 616 (4.55%)
    5 / 91 (5.49%)
    5 / 90 (5.56%)
    3 / 91 (3.30%)
    1 / 100 (1.00%)
         occurrences all number
    12
    37
    7
    10
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    13 / 321 (4.05%)
    33 / 616 (5.36%)
    3 / 91 (3.30%)
    6 / 90 (6.67%)
    5 / 91 (5.49%)
    5 / 100 (5.00%)
         occurrences all number
    14
    33
    3
    6
    5
    8
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    33 / 321 (10.28%)
    73 / 616 (11.85%)
    7 / 91 (7.69%)
    8 / 90 (8.89%)
    12 / 91 (13.19%)
    10 / 100 (10.00%)
         occurrences all number
    39
    92
    8
    8
    15
    11
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 321 (1.87%)
    10 / 616 (1.62%)
    9 / 91 (9.89%)
    9 / 90 (10.00%)
    6 / 91 (6.59%)
    10 / 100 (10.00%)
         occurrences all number
    6
    10
    9
    9
    7
    10
    Nasopharyngitis
         subjects affected / exposed
    8 / 321 (2.49%)
    9 / 616 (1.46%)
    7 / 91 (7.69%)
    5 / 90 (5.56%)
    7 / 91 (7.69%)
    6 / 100 (6.00%)
         occurrences all number
    8
    9
    10
    6
    9
    6
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 321 (4.36%)
    9 / 616 (1.46%)
    3 / 91 (3.30%)
    3 / 90 (3.33%)
    5 / 91 (5.49%)
    9 / 100 (9.00%)
         occurrences all number
    14
    9
    3
    3
    5
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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