Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, double-blind, multi-center, parallel-group, placebo-controlled dose-ranging study to assess the efficacy and safety of nemolizumab (CD14152) in moderate-to-severe atopic dermatitis subjects with severe pruritus receiving topical corticosteroids

    Summary
    EudraCT number
    		 2016-005025-37
    Trial protocol
    		 DE   FR   PL  
    Global end of trial date
    21 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2019
    First version publication date
    19 Oct 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.03.SRE.114322
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03100344
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GALDERMA R&D, SNC
    Sponsor organisation address
    Les Templiers, 2400 route des Colles, Biot, France, 06410
    Public contact
    RA CTA Coordinator, GALDERMA R&D, SNC, +33 (0)4 93 95 70 85, cta.coordinator@galderma.com
    Scientific contact
    Galderma Medical Expert, GALDERMA R&D, SNC, +33 (0)4 93 95 70 85, Zarif.Jabbar-Lopez@galderma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe AD subjects with severe pruritus receiving topical corticosteroid who were not adequately controlled with topical treatments.
    Protection of trial subjects
    The study was conducted according to the protocol and subsequent amendments. At each study site, the protocol and informed consent form (ICF) for this study were reviewed and approved by a duly constituted Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before subjects were screened for entry. This study was conducted in accordance with Good Clinical Practice (GCP) as required by the International Conference for Harmonisation (ICH) guidelines and in accordance with country-specific laws and regulations governing clinical studies of investigational products. Subjects were provided with both verbal and written information regarding the study, including its objectives, possible benefits and risks, and its consequences. Sufficient time was allowed for the subjects to read the study information and ask questions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 63
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    United States: 69
    Worldwide total number of subjects
    226
    EEA total number of subjects
    112
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    209
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 57 investigational sites in Australia, Canada, Germany, France, Poland and the United States.

    Pre-assignment
    Screening details
    		 In this study, 226 participants with moderate-to-severe atopic dermatitis (AD) were randomized across the 4 treatment groups after a 2 to 4-week run-in period. All participants underwent inclusion exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This was a double-blind clinical study; Investigator’s, site staff, and subjects did not know which treatment they were receiving. The study was blinded to the contract research organization (CRO) and Sponsor study team until after final database lock (once all subjects completed safety follow-up at Week 32) and subsequent unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroid (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Each participant was randomized to receive subcutaneous injections of placebo every 4 weeks (Q4W) (Weeks 4, 8, 12, 16 and 20).

    Arm title
    		 Nemolizumab (10 mg)
    Arm description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS were considered unsafe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CD14152
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomized participants received Nemolizumab subcutaneous injection 10 mg every 4 weeks during 24 week treatment period (last injection at Week 20)

    Arm title
    		 Nemolizumab (30 mg)
    Arm description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomized participants received Nemolizumab subcutaneous injection 30 mg every 4 weeks during 24 week treatment period (last injection at Week 20)

    Arm title
    		 Nemolizumab (90 mg)
    Arm description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomized participants received Nemolizumab subcutaneous injection 90 mg every 4 weeks during 24 week treatment period (last injection at Week 20)

    Number of subjects in period 1
    		Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Started
    57
    55
    57
    57
    Completed
    43
    44
    50
    45
    Not completed
    14
    11
    7
    12
         Consent withdrawn by subject
    10
    7
    4
    8
         Adverse event, non-fatal
    -
    3
    2
    3
         Lost to follow-up
    1
    1
    1
    1
         Lack of efficacy
    2
    -
    -
    -
         Protocol deviation
    1
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroid (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (10 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS were considered unsafe.

    Reporting group title
    Nemolizumab (30 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (90 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg) Total
    Number of subjects
    		 57 55 57 57 226
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 54 53 51 51 209
        From 65-84 years
    		 3 2 6 6 17
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ( 15.01 ) 35.3 ( 14.83 ) 40.2 ( 16.64 ) 40.9 ( 14.95 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 26 28 31 111
        Male
    		 31 29 29 26 115
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 1
        Asian
    		 4 11 6 4 25
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 8 3 10 8 29
        White
    		 45 38 40 44 167
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 2 1 1 4
    Height
    Units: Centimeter
        arithmetic mean (standard deviation)
    		 170.0 ( 10.28 ) 169.7 ( 8.98 ) 171.5 ( 8.55 ) 170.6 ( 9.94 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 80.58 ( 18.835 ) 73.72 ( 14.629 ) 76.90 ( 18.613 ) 80.49 ( 22.770 ) -
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.79 ( 5.638 ) 25.54 ( 4.429 ) 26.18 ( 6.370 ) 27.51 ( 6.694 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroid (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (10 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS were considered unsafe.

    Reporting group title
    Nemolizumab (30 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (90 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat (ITT) population included all randomized participants. The ITT population was analyzed according to the treatment groups or stratum assigned at randomization.

    Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
    End point description
    EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Percentage change
        arithmetic mean (standard deviation)
    -58.4 ( 31.99 )
    -72.2 ( 25.96 )
    -73.4 ( 29.67 )
    -69.2 ( 31.06 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Treatment difference from Placebo
    Comparison groups
    Nemolizumab (10 mg) v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.051
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -13.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 0
    Notes
    [1] - mixed-effect model for repeated measures (MMRM)
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.016
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -16.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 -3.2
    Notes
    [2] - mixed-effect model for repeated measures (MMRM)
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.322
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.5
         upper limit
    		 6.8
    Notes
    [3] - mixed-effect model for repeated measures (MMRM)

    Secondary: Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24

    		 Close Top of page
    End point title
    		 Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
    End point description
    The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: participants
    13
    23
    31
    20
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 35.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.7
         upper limit
    		 48.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.154
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 28.6

    Secondary: Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24

    		 Close Top of page
    End point title
    		 Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
    End point description
    Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 52, 53, 52; Week 2 n:53, 50,55, 50; Week 4 n: 52, 50, 51,49; Week 8 n: 50, 45, 51, 46; Week 12 n: 41, 41, 48, 42; Week 16 n: 39, 39, 47, 40; Week 20 n: 34,37, 41, 36; Week 24 n: 32, 33, 36, 31.
    End point type
    Secondary
    End point timeframe
    From Week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    3
    9
    10
    6
        Week 2
    6
    19
    21
    17
        Week 4
    4
    19
    27
    22
        Week 8
    11
    22
    36
    26
        Week 12
    13
    26
    38
    24
        Week 16
    12
    30
    39
    25
        Week 20
    13
    27
    34
    27
        Week 24
    14
    25
    28
    24
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 22.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 23.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 15
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.3
         upper limit
    		 38.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.4
         upper limit
    		 40.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 33.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    27.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.5
         upper limit
    		 41.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    40.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.7
         upper limit
    		 54.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    31.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.4
         upper limit
    		 45.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 37.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    43.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.6
         upper limit
    		 59.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.7
         upper limit
    		 42.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 41.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    43.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.4
         upper limit
    		 59.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 35.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    33.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.4
         upper limit
    		 50.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    47.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.2
         upper limit
    		 63.2
    Statistical analysis title
    		 Placebo, vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.1
         upper limit
    		 39.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.2
         upper limit
    		 43.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    36.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.1
         upper limit
    		 53.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.6
         upper limit
    		 41.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 38.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.4
         upper limit
    		 41.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 34.4

    Secondary: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
    End point description
    SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
    End point type
    Secondary
    End point timeframe
    At baseline and at week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: percentage change
        arithmetic mean (standard deviation)
    -42.6 ( 28.25 )
    -60.8 ( 25.04 )
    -62.5 ( 25.37 )
    -55.9 ( 25.85 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Comparison groups
    Nemolizumab (10 mg) v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.017
    Method
    		 Kenward Roger]
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.2
         upper limit
    		 -2.7
    Notes
    [4] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.6
         upper limit
    		 -8.3
    Notes
    [5] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.058
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.1
         upper limit
    		 0.4
    Notes
    [6] - mixed-effect model for repeated measures

    Secondary: Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
    End point description
    SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
    End point type
    Secondary
    End point timeframe
    At week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -27.9 ( 19.61 )
    -40.1 ( 19.19 )
    -40.6 ( 17.22 )
    -36.1 ( 16.56 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.016
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.5
         upper limit
    		 -1.8
    Notes
    [7] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.6
         upper limit
    		 -5.1
    Notes
    [8] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.058
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.4
         upper limit
    		 0.3
    Notes
    [9] - mixed-effect model for repeated measures

    Secondary: Percent Change from Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
    End point description
    The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions 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’. Higher scores indicate worse outcome.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Percentage change
        arithmetic mean (standard deviation)
    -50.7 ( 33.52 )
    -75.4 ( 27.64 )
    -76.2 ( 23.60 )
    -74.9 ( 29.39 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.8
         upper limit
    		 -11.2
    Notes
    [10] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -31.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.9
         upper limit
    		 -18.6
    Notes
    [11] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -25.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.4
         upper limit
    		 -11.8
    Notes
    [12] - mixed-effect model for repeated measures

    Secondary: Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
    End point description
    The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions 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'. Higher scores indicate worse outcome.
    End point type
    Secondary
    End point timeframe
    At baseline and week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -3.9 ( 2.74 )
    -6.2 ( 2.34 )
    -5.7 ( 2.51 )
    -5.8 ( 2.62 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -1
    Notes
    [13] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 -1.3
    Notes
    [14] - mixed-effect model for repeated measures
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of absolute changes
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.9
    Notes
    [15] - mixed-effect model for repeated measures

    Secondary: Number of Participants Achieving Investigator’s Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24

    		 Close Top of page
    End point title
    		 Number of Participants Achieving Investigator’s Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
    End point description
    IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) usedto evaluate the global severity of AD. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55,57; Week 2 n: 55, 55, 55, 57; Week 4 n: 54, 55, 54, 56; Week 8 n: 52, 53, 52, 54; Week 12 n: 45, 46, 50, 51; Week 16 n: 44, 46, 47, 45; Week 20 n: 39, 42, 46, 41; Week 24 n: 38, 40, 44, 40.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    1
    1
    2
    0
        Week 2
    2
    1
    4
    1
        Week 4
    2
    1
    9
    7
        Week 8
    2
    3
    10
    11
        Week 12
    6
    6
    15
    15
        Week 16
    7
    9
    19
    15
        Week 20
    9
    11
    19
    14
        Week 24
    12
    14
    21
    13
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 5.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.574
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 7.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.311
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 1.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.558
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 4.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 11.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.543
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.583
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 4.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 22.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.087
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 18.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.632
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 9.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 24.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 27
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 11.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 29.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 29.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.553
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 16.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.1
         upper limit
    		 35.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 28.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.585
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 18
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 32.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.254
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 23.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.598
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 19.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.066
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 31.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.826
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 16.9

    Secondary: Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
    End point description
    EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55, 57; Week 2 n: 55, 55, 55,57; Week 4 n: 54, 55, 54, 56; Week 8 n: 52, 53, 52, 54; Week 12 n: 45, 46, 50, 51; Week 16 n: 44, 46, 47, 45; Week 20 n: 39, 42, 46, 41; Week 24 n: 38, 40, 44, 40.
    End point type
    Secondary
    End point timeframe
    From week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    4
    6
    12
    11
        Week 2
    8
    18
    18
    21
        Week 4
    14
    22
    29
    24
        Week 8
    15
    26
    31
    31
        Week 12
    20
    30
    36
    30
        Week 16
    21
    30
    34
    32
        Week 20
    23
    32
    38
    33
        Week 24
    25
    33
    38
    31
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.487
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 14.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.033
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 26.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 23.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 33.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.027
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 32.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 38.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.086
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 32.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.3
         upper limit
    		 43.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 34.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 38.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 45
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 45
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 37.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.4
         upper limit
    		 45.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 35.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.064
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 35.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 40.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 36.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.064
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 35.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 43.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.064
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 35
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.094
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 33.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1
         upper limit
    		 39.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.273
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 28

    Secondary: Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
    End point description
    EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55, 57; Week 2 n: 55, 55, 55, 57; Week 4 n: 54, 55, 54, 56; Week 8n: 52, 53, 52, 54; Week 12 n: 45, 46, 50, 51; Week 16 n: 44, 46, 47, 45; Week 20 n: 39, 42, 46, 41; Week 24 n: 38, 40, 44, 40.
    End point type
    Secondary
    End point timeframe
    From week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    2
    2
    3
    3
        Week 2
    4
    5
    6
    12
        Week 4
    3
    7
    12
    15
        Week 8
    7
    10
    21
    15
        Week 12
    10
    15
    25
    21
        Week 16
    11
    18
    28
    21
        Week 20
    16
    21
    25
    21
        Week 24
    15
    20
    26
    25
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.979
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.668
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.658
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 9.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 12.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.521
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 13.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.033
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 26.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.172
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 18
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.7
         upper limit
    		 27.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.2
         upper limit
    		 33.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.404
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 18.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.4
         upper limit
    		 39.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 28.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.222
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 25
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10
         upper limit
    		 42.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 35
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.111
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 29.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    29.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.2
         upper limit
    		 46
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 33.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.262
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 27.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.327
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 25.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 33.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 27.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 35.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 34.6

    Secondary: Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
    End point description
    EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55, 57; Week 2 n: 55, 55, 55, 57; Week 4 n: 54, 55, 54, 56; Week 8 n: 52, 53, 52, 54; Week 12 n: 45, 46, 50, 51; Week 16 n: 44, 46, 47, 45; Week 20 n: 39, 42, 46, 41; Week 24 n: 38, 40, 44, 40.
    End point type
    Secondary
    End point timeframe
    From week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    1
    1
    2
    1
        Week 2
    2
    0
    2
    2
        Week 4
    2
    1
    4
    3
        Week 8
    1
    3
    11
    6
        Week 12
    4
    7
    13
    14
        Week 16
    5
    10
    19
    12
        Week 20
    6
    13
    18
    14
        Week 24
    6
    13
    17
    13
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 5.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.574
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 7.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.985
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 4.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.154
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 1.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.978
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 6.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.978
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 6.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.602
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 4.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 11.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.658
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 9.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 10.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.9
         upper limit
    		 27.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.054
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 17.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.325
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 16.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 28.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 30.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.153
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 21.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.3
         upper limit
    		 38.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 25.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 26.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 35.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 27.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 26.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 33.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 25.7

    Secondary: Number of participants achieving Investigator Global Assessment (IGA) success (defined as IGA 0 [clear] or 1 [almost clear]) and a reduction of ≥2 points at each visit up to Week 24

    		 Close Top of page
    End point title
    		 Number of participants achieving Investigator Global Assessment (IGA) success (defined as IGA 0 [clear] or 1 [almost clear]) and a reduction of ≥2 points at each visit up to Week 24
    End point description
    IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55, 57; Week 2 n:55, 55, 55, 57; Week 4 n: 54, 55, 54, 56; Week 8 n: 52,53, 52, 54; Week 12 n: 45, 46, 50, 51; Week 16 n:44, 46, 47, 45; Week 20 n: 39, 42, 46, 41; Week 24 n: 38, 40, 44, 40.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Participants
        Week 1
    1
    1
    2
    0
        Week 2
    2
    1
    4
    1
        Week 4
    2
    1
    9
    7
        Week 8
    2
    3
    10
    11
        Week 12
    6
    6
    15
    15
        Week 16
    7
    9
    19
    15
        Week 20
    9
    11
    19
    14
        Week 24
    12
    14
    21
    13
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 5.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.574
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 7.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.311
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 1.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.558
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 4.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 11.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.543
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.583
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 4.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 22.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.087
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 18.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.632
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 9.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 24.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Nemolizumab (90 mg) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 27
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 11.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 29.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 29.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.553
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 16.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.1
         upper limit
    		 35.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 28.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.585
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 18
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 32.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.254
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 23.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.598
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 19.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.066
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 31.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.826
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 16.9

    Secondary: Percentage Change from Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Percentage Change from Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
    End point description
    EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 53, 55, 57; Week 2 n:55, 55,55, 57; Week 4 n: 54, 55, 54,56; Week 8 n: 52, 53, 52, 54; Week 12 n: 45,46,50,51; Week 16 n: 44,46,47,45; Week 20 n: 39,42,46,41; Week 24 n: 38,40,44,40.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Percentage change
    arithmetic mean (standard deviation)
        Week 1
    -12.4 ( 24.32 )
    -22.7 ( 23.54 )
    -29.3 ( 31.44 )
    -28.6 ( 25.52 )
        Week 2
    -24.8 ( 29.16 )
    -34.9 ( 27.70 )
    -40.1 ( 26.96 )
    -40.1 ( 32.83 )
        Week 4
    -26.5 ( 33.45 )
    -40.3 ( 28.36 )
    -46.7 ( 38.49 )
    -41.8 ( 41.57 )
        Week 8
    -28.6 ( 36.85 )
    -42.0 ( 38.15 )
    -51.7 ( 47.73 )
    -49.9 ( 37.21 )
        Week 12
    -43.3 ( 35.22 )
    -58.5 ( 28.16 )
    -64.1 ( 33.92 )
    -56.7 ( 37.25 )
        Week 16
    -47.6 ( 32.09 )
    -59.1 ( 33.90 )
    -72.2 ( 27.59 )
    -61.8 ( 41.62 )
        Week 20
    -57.3 ( 31.66 )
    -67.2 ( 35.18 )
    -71.6 ( 29.39 )
    -70.9 ( 27.07 )
        Week 24
    -58.4 ( 31.99 )
    -72.2 ( 25.96 )
    -73.4 ( 29.67 )
    -69.2 ( 31.06 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.049
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 0
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -16.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.7
         upper limit
    		 -7
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -15.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 -5.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.9
         upper limit
    		 1.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -16.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.2
         upper limit
    		 -5.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -14.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.8
         upper limit
    		 -3.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Nemolizumab (10 mg) v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.5
         upper limit
    		 -0.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.7
         upper limit
    		 -7.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -15.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.8
         upper limit
    		 -1.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -14.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 0.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -23.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.9
         upper limit
    		 -7.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -20.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36
         upper limit
    		 -5.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.4
         upper limit
    		 -2.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -23.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.1
         upper limit
    		 -10.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -14.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.1
         upper limit
    		 -1.3
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.6
         upper limit
    		 1.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -23.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.5
         upper limit
    		 -8.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.154
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 4.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 1.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.7
         upper limit
    		 -2.1
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.4
         upper limit
    		 4.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -13.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 0
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -16.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 -3.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.322
    Method
    		 Kenward-Rogers
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.5
         upper limit
    		 6.8

    Secondary: Percent Change from Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
    End point description
    Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 55, 52, 53, 52; Week 2 n:53, 50,55, 50; Week 4 n: 52, 50, 51,49; Week 8 n: 50, 45, 51, 46; Week 12 n: 41, 41, 48, 42; Week 16 n: 39, 39, 47, 40; Week 20 n: 34, 37, 41, 36; Week 24 n: 32, 33, 36, 31.
    End point type
    Secondary
    End point timeframe
    At baseline and Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Percentage of change
    arithmetic mean (standard deviation)
        Week 1
    -9.8 ( 18.47 )
    -22.6 ( 21.76 )
    -25.5 ( 30.15 )
    -19.8 ( 21.16 )
        Week 2
    -12.9 ( 23.97 )
    -36.9 ( 27.34 )
    -42.1 ( 23.91 )
    -37.6 ( 32.29 )
        Week 4
    -16.3 ( 23.77 )
    -38.7 ( 30.25 )
    -51.8 ( 26.87 )
    -45.7 ( 32.64 )
        Week 8
    -23.0 ( 23.88 )
    -48.2 ( 28.82 )
    -61.5 ( 24.16 )
    -58.0 ( 28.63 )
        Week 12
    -28.2 ( 28.83 )
    -58.0 ( 28.99 )
    -68.7 ( 25.04 )
    -56.4 ( 29.81 )
        Week 16
    -36.2 ( 30.25 )
    -61.4 ( 28.62 )
    -71.7 ( 22.53 )
    -63.7 ( 33.07 )
        Week 20
    -38.0 ( 30.11 )
    -64.6 ( 28.62 )
    -69.9 ( 26.30 )
    -69.7 ( 28.47 )
        Week 24
    -42.2 ( 31.66 )
    -65.8 ( 29.94 )
    -66.9 ( 38.60 )
    -68.2 ( 26.88 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.4
         upper limit
    		 -2.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -15.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.8
         upper limit
    		 -7.1
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 1
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 -0.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -21.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 -11.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -29.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.1
         upper limit
    		 -19.1
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -23.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34
         upper limit
    		 -13.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -21.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.1
         upper limit
    		 -10.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -34.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.5
         upper limit
    		 -24.2
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -30.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.6
         upper limit
    		 -19.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -22.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.2
         upper limit
    		 -12.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -37.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.4
         upper limit
    		 -27.2
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -34.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.4
         upper limit
    		 -23.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.6
         upper limit
    		 -12.5
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -38.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.7
         upper limit
    		 -27.2
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -30.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.7
         upper limit
    		 -18.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.8
         upper limit
    		 -8.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -34.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46
         upper limit
    		 -22.6
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -28.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.7
         upper limit
    		 -16.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.7
         upper limit
    		 -8.4
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -29.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -42.1
         upper limit
    		 -17.3
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.6
         upper limit
    		 -15.2
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -22.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.1
         upper limit
    		 -8.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -31.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.9
         upper limit
    		 -18
    Statistical analysis title
    		 Placebo v Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Nemolizumab (90 mg) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.8
         upper limit
    		 -16.2

    Secondary: Number of Participants With Adverse Events

    		 Close Top of page
    End point title
    		 Number of Participants With Adverse Events
    End point description
    To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
    End point type
    Secondary
    End point timeframe
    From screening to Follow-up visit (Week 32)/Early termination visit
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    56
    55
    57
    57
    Units: Participants
        Subjects with treatment-emergent SAEs
    1
    3
    2
    2
        TEAE with fatal outcome
    0
    1
    0
    0
        Subjects with TEAE leading to temporary study drug
    0
    1
    2
    1
        Subjects with TEAE leading to permanent study drug
    4
    4
    2
    7
        Subjects with TEAE leading to study withdrawal
    0
    3
    2
    3
        Subjects with at least 1 TEAE
    43
    47
    47
    48
        Subjects with severe TEAEs
    6
    3
    5
    2
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
    End point description
    Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 56, 52, 53,52; Week 2 n: 54, 50, 55, 50; Week 4 n: 55, 50, 53, 50; Week 8 n: 53, 45, 54, 47; Week 12 n: 43, 43, 52, 43; Week 16 n: 39, 41, 52, 42; Week 20 n: 36, 40, 47, 38; Week 24 n: 32, 33, 36, 31.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1
    -0.9 ( 1.38 )
    -2.0 ( 1.96 )
    -2.3 ( 1.89 )
    -1.7 ( 1.66 )
        Week 2
    -1.2 ( 1.82 )
    -3.1 ( 2.34 )
    -3.4 ( 1.96 )
    -3.3 ( 2.56 )
        Week 4
    -1.4 ( 1.84 )
    -3.4 ( 2.62 )
    -4.2 ( 2.21 )
    -3.8 ( 2.73 )
        Week 8
    -1.9 ( 1.94 )
    -4.1 ( 2.58 )
    -5.0 ( 2.14 )
    -4.7 ( 2.54 )
        Week 12
    -2.3 ( 2.44 )
    -4.9 ( 2.45 )
    -5.6 ( 2.29 )
    -4.7 ( 2.66 )
        Week 16
    -2.9 ( 2.55 )
    -5.2 ( 2.34 )
    -5.8 ( 2.25 )
    -5.1 ( 2.77 )
        Week 20
    -3.1 ( 2.52 )
    -5.4 ( 2.61 )
    -5.9 ( 2.22 )
    -5.4 ( 2.66 )
        Week 24
    -3.5 ( 2.65 )
    -5.6 ( 2.55 )
    -5.8 ( 2.54 )
    -5.5 ( 2.33 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -1
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 -1.8
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.3

    Secondary: Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
    End point description
    Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 56, 52, 53,52; Week 2 n: 54, 50, 55, 50; Week 4 n: 55, 50, 53, 50; Week 8 n: 53, 45, 54, 47; Week 12 n: 43, 43, 52, 43 Week 16 n: 39, 41, 52, 42; Week 20 n: 36, 40, 47, 38; Week 24 n: 32, 33, 36, 31.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1
    -0.9 ( 1.24 )
    -2.0 ( 1.94 )
    -2.3 ( 1.86 )
    -1.8 ( 1.64 )
        Week 2
    -1.2 ( 1.73 )
    -3.1 ( 2.32 )
    -3.3 ( 1.89 )
    -3.3 ( 2.50 )
        Week 4
    -1.5 ( 1.73 )
    -3.5 ( 2.47 )
    -4.1 ( 2.16 )
    -3.8 ( 2.63 )
        Week 8
    -2.1 ( 1.95 )
    -4.1 ( 2.42 )
    -4.9 ( 2.13 )
    -4.7 ( 2.39 )
        Week 12
    -2.4 ( 2.43 )
    -4.9 ( 2.48 )
    -5.5 ( 2.29 )
    -4.6 ( 2.50 )
        Week 16
    -3.0 ( 2.47 )
    -5.3 ( 2.18 )
    -5.7 ( 2.19 )
    -5.1 ( 2.59 )
        Week 20
    -3.3 ( 2.55 )
    -5.3 ( 2.47 )
    -5.8 ( 2.18 )
    -5.3 ( 2.50 )
        Week 24
    -3.7 ( 2.59 )
    -5.5 ( 2.53 )
    -5.6 ( 2.49 )
    -5.2 ( 2.19 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 -1.6
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -1.1

    Secondary: Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

    		 Close Top of page
    End point title
    		 Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
    End point description
    Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’. Higher scores indicate worse outcome. Note: n=number of subjects in analysis. Week 1 n: 56, 52, 53,52; Week 2 n: 54, 50, 55, 50; Week 4 n: 55, 50, 53, 50; Week 8 n: 53, 45, 54,47; Week 12 n: 43, 43, 52, 43; Week 16 n: 39, 41, 52, 42; Week 20 n: 36, 40, 47, 38; Week 24 n: 32, 33, 36, 31.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Number of subjects analysed
    57
    55
    57
    57
    Units: Percentage of change
    arithmetic mean (standard deviation)
        Week 1
    -11.0 ( 16.33 )
    -24.6 ( 23.39 )
    -29.4 ( 28.24 )
    -23.2 ( 22.63 )
        Week 2
    -14.6 ( 23.01 )
    -39.9 ( 29.89 )
    -45.2 ( 25.06 )
    -40.4 ( 33.77 )
        Week 4
    -19.7 ( 22.48 )
    -43.5 ( 31.66 )
    -55.8 ( 27.60 )
    -48.2 ( 33.16 )
        Week 8
    -26.9 ( 25.34 )
    -52.0 ( 29.50 )
    -65.1 ( 24.67 )
    -61.5 ( 28.03 )
        Week 12
    -30.9 ( 31.63 )
    -61.7 ( 30.02 )
    -72.2 ( 25.36 )
    -60.1 ( 29.77 )
        Week 16
    -40.2 ( 31.73 )
    -66.8 ( 27.02 )
    -73.9 ( 22.83 )
    -67.1 ( 31.64 )
        Week 20
    -42.7 ( 32.43 )
    -67.5 ( 30.03 )
    -74.5 ( 24.85 )
    -70.6 ( 29.39 )
        Week 24
    -47.7 ( 32.60 )
    -68.7 ( 30.60 )
    -69.9 ( 35.76 )
    -70.5 ( 26.41 )
    Statistical analysis title
    		 Placebo vs Nemolizumab (10 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (10 mg)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -23.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.7
         upper limit
    		 -9.9
    Statistical analysis title
    		 Placebo vs Nemolizumab (30 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (30 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger]
    Parameter type
    		 mean difference of percentage changes]
    Point estimate
    -31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45
         upper limit
    		 -17.7
    Statistical analysis title
    		 Placebo vs Nemolizumab (90 mg)
    Statistical analysis description
    Week 24
    Comparison groups
    Placebo v Nemolizumab (90 mg)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Kenward Roger
    Parameter type
    		 mean difference of percentage changes
    Point estimate
    -29.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.2
         upper limit
    		 -15.2

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From screening to Follow-up visit (Week 32)/Early termination visit
    Adverse event reporting additional description
    An AE is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (10 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (30 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Reporting group title
    Nemolizumab (90 mg)
    Reporting group description
    		 Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.

    Serious adverse events
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    2 / 57 (3.51%)
    2 / 57 (3.51%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Post-traumatic amnestic disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 57 (1.75%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 57 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 57 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Nemolizumab (10 mg) Nemolizumab (30 mg) Nemolizumab (90 mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 56 (76.79%)
    47 / 55 (85.45%)
    47 / 57 (82.46%)
    47 / 57 (82.46%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 55 (3.64%)
    1 / 57 (1.75%)
    1 / 57 (1.75%)
         occurrences all number
    4
    3
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 56 (12.50%)
    7 / 55 (12.73%)
    4 / 57 (7.02%)
    5 / 57 (8.77%)
         occurrences all number
    8
    10
    5
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 57 (1.75%)
    3 / 57 (5.26%)
         occurrences all number
    0
    1
    1
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    3 / 57 (5.26%)
    1 / 57 (1.75%)
         occurrences all number
    4
    3
    3
    1
    Nausea
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 55 (7.27%)
    1 / 57 (1.75%)
    1 / 57 (1.75%)
         occurrences all number
    3
    4
    2
    1
    Abdominal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    3 / 57 (5.26%)
    0 / 57 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    7 / 57 (12.28%)
    10 / 57 (17.54%)
         occurrences all number
    1
    3
    8
    12
    Cough
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    3 / 57 (5.26%)
    2 / 57 (3.51%)
         occurrences all number
    2
    1
    6
    2
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    18 / 56 (32.14%)
    11 / 55 (20.00%)
    13 / 57 (22.81%)
    16 / 57 (28.07%)
         occurrences all number
    21
    13
    15
    18
    Dry skin
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    3 / 57 (5.26%)
    0 / 57 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    3 / 57 (5.26%)
    2 / 57 (3.51%)
         occurrences all number
    2
    1
    3
    2
    Arthralgia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    3 / 57 (5.26%)
    0 / 57 (0.00%)
         occurrences all number
    1
    4
    4
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 56 (21.43%)
    18 / 55 (32.73%)
    14 / 57 (24.56%)
    13 / 57 (22.81%)
         occurrences all number
    19
    22
    18
    17
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 55 (7.27%)
    6 / 57 (10.53%)
    4 / 57 (7.02%)
         occurrences all number
    1
    5
    6
    4
    Sinusitis
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 55 (7.27%)
    3 / 57 (5.26%)
    1 / 57 (1.75%)
         occurrences all number
    0
    4
    3
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    3 / 57 (5.26%)
    4 / 57 (7.02%)
         occurrences all number
    1
    0
    3
    4
    Oral herpes
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    1 / 57 (1.75%)
    3 / 57 (5.26%)
         occurrences all number
    1
    2
    3
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    1 / 57 (1.75%)
    1 / 57 (1.75%)
         occurrences all number
    5
    3
    1
    1
    Rhinitis
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 55 (0.00%)
    3 / 57 (5.26%)
    1 / 57 (1.75%)
         occurrences all number
    4
    0
    3
    2
    Folliculitis
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    3 / 57 (5.26%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    3
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2017
    To provide clarity to the definition of severe pruritus, inclusion criterion 17 was amended to utilize a single scale, pruritus NRS, for study entry. To qualify for inclusion, the average of pruritus NRS for the maximum intensity had to be ≥7 during the 7 days prior to the Baseline Visit. The PCS measurement was still recorded but was not used to determine the subject’s eligibility.
    01 Jun 2018
    Jonathan Silverberg, MD was designated as the Coordinating Investigator pursuant to the European Agency for the Evaluation of Medicinal Products guidance on “Coordinating Investigator Signature of Clinical Trial Reports”.

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

    European Medicines Agency © 1995-Fri Apr 26 20:41:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA