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    Clinical Trial Results:
    A study to assess the safety and efficacy of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)

    Summary
    EudraCT number
    		 2017-001715-36
    Trial protocol
    		 DE   AT   FR   PL  
    Global end of trial date
    26 Sep 2018

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.03.SRE.115828
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03181503
    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)493 95 70 85, cta.coordinator@galderma.com
    Scientific contact
    Galderma Medical Expert, Zarif.Jabbar, GALDERMA R&D, SNC, 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
    12 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects suffering from prurigo nodularis (PN).
    Protection of trial subjects
    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) and provided to PAREXEL before subjects were screened for entry. Amendments to the protocol and ICF were reviewed and approved in the same manner before being implemented. This study was conducted in accordance with Good Clinical Practice (GCP) as required by the International Council for Harmonisation (ICH) guidelines and in accordance with country-specific laws and regulations governing clinical studies of investigational products. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki (1964) and subsequent amendments. All subjects who participated in this clinical study were informed about the clinical study according to GCP guidelines, federal regulations, Health Insurance Portability and Accountability Act (HIPAA) for the United States (US), and in accordance with local requirements. 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
    02 Nov 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
    Austria: 9
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 24
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    46
    From 65 to 84 years
    23
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The subjects were randomized at 16 investigational sites in Austria, France, Germany and Poland.

    Pre-assignment
    Screening details
    		 This study consisted of a screening period of up to 4 weeks. All assessments at screening were done as per the schedule of assessment.

    Period 1
    Period 1 title
    Overall (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, therefore neither the subject nor the Investigator/evaluator knew which treatment was assigned to each subject. Except for the pharmacist (or other qualified personnel) who handled study drug preparation, and the Clinical Research Associate (CRA) who monitored the drug records and study data, the study remained blinded to all study individuals until after final database lock and subsequent unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Each subject was randomized to receive three subcutaneous injections of matching placebo every 4 weeks (Q4W) (at Baseline, Week 4 & Week 8).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three Subcutaneous injections (Baseline, Week 4, Week 8)

    Arm title
    		 Nemolizumab
    Arm description
    		 Each subject was randomized to receive three subcutaneous injections of 0.5 mg/kg of nemolizumab Q4W (at Baseline, Week 4 & Week 8).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CD14152
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three Subcutaneous injections (Baseline, Week 4, Week 8)

    Number of subjects in period 1
    		Placebo Nemolizumab
    Started
    36
    34
    Completed
    29
    31
    Not completed
    7
    3
         Protocol violation
    1
    -
         Adverse event
    2
    2
         Lost to follow-up
    1
    1
         Withdrawal by subject
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of matching placebo every 4 weeks (Q4W) (at Baseline, Week 4 & Week 8).

    Reporting group title
    Nemolizumab
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of 0.5 mg/kg of nemolizumab Q4W (at Baseline, Week 4 & Week 8).

    Reporting group values
    		 Placebo Nemolizumab Total
    Number of subjects
    		 36 34 70
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.4 ( 17.47 ) 59.7 ( 13.16 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 14 15 29

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of matching placebo every 4 weeks (Q4W) (at Baseline, Week 4 & Week 8).

    Reporting group title
    Nemolizumab
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of 0.5 mg/kg of nemolizumab Q4W (at Baseline, Week 4 & Week 8).

    Primary: Percent change from Baseline in pruritus numeric rating scale (NRS) to Week 4 (weekly average of the peak), using last observation carried forward (LOCF) approach

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    End point title
    		 Percent change from Baseline in pruritus numeric rating scale (NRS) to Week 4 (weekly average of the peak), using last observation carried forward (LOCF) approach
    End point description
    To assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects suffering from PN. The pruritus NRS was used by subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 4
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    34
    33
    Units: Percentage
        arithmetic mean (standard deviation)
    -13.8 ( 16.10 )
    -52.6 ( 33.96 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51
         upper limit
    		 -25

    Primary: Percent change from Baseline in pruritus NRS to Week 4 (weekly average of the peak), sensitivity analysis using multiple imputation method

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    End point title
    		 Percent change from Baseline in pruritus NRS to Week 4 (weekly average of the peak), sensitivity analysis using multiple imputation method
    End point description
    To assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects suffering from PN. The pruritus NRS was used by-subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 4
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
        arithmetic mean (standard deviation)
    -18.3 ( 22.39 )
    -52.0 ( 33.94 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47
         upper limit
    		 -19.1

    Primary: Percent change from Baseline in pruritus NRS to Week 4 (weekly average of the peak), sensitivity analysis using observed data

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    End point title
    		 Percent change from Baseline in pruritus NRS to Week 4 (weekly average of the peak), sensitivity analysis using observed data
    End point description
    To assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects suffering from PN. The pruritus NRS was used by-subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 4
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    32
    31
    Units: Percentage
        arithmetic mean (standard deviation)
    -15.2 ( 17.42 )
    -54.9 ( 33.80 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -38.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.2
         upper limit
    		 -25.3

    Secondary: Percent change from Baseline in weekly average of the peak pruritus NRS by timepoint, using LOCF approach

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    End point title
    		 Percent change from Baseline in weekly average of the peak pruritus NRS by timepoint, using LOCF approach
    End point description
    To evaluate the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects with PN. The pruritus NRS was used by subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1 (n = 33, 32)
    -6.1 ( 11.45 )
    -26.0 ( 21.93 )
        Week 2 (n = 34, 33)
    -7.4 ( 14.85 )
    -41.7 ( 30.31 )
        Week 4, (n = 34, 33)
    -13.8 ( 16.10 )
    -52.6 ( 33.96 )
        Week 8, (n = 34, 33)
    -19.7 ( 20.03 )
    -56.5 ( 34.73 )
        Week 12, (n = 34, 33)
    -18.7 ( 22.80 )
    -61.8 ( 34.95 )
        Week 16, (n = 34, 33)
    -20.8 ( 22.29 )
    -61.1 ( 35.35 )
        Week 18, (n = 34, 33)
    -21.7 ( 22.95 )
    -59.6 ( 35.89 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.5
         upper limit
    		 -10.9
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.7
         upper limit
    		 -22.4
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51
         upper limit
    		 -25
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50
         upper limit
    		 -22.1
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -42.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -57.7
         upper limit
    		 -28.2
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.4
         upper limit
    		 -25
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -37.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.4
         upper limit
    		 -22.3

    Secondary: Absolute change from Baseline in weekly average of the peak pruritus NRS by timepoint, using LOCF approach

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    End point title
    		 Absolute change from Baseline in weekly average of the peak pruritus NRS by timepoint, using LOCF approach
    End point description
    To evaluate the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects with PN. The pruritus NRS was used by subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 32)
    -0.5 ( 0.87 )
    -2.1 ( 1.66 )
        Week 2, (n = 34, 33)
    -0.6 ( 1.21 )
    -3.4 ( 2.38 )
        Week 4, (n = 34, 33)
    -1.2 ( 1.33 )
    -4.3 ( 2.77 )
        Week 8, (n = 34, 33)
    -1.6 ( 1.62 )
    -4.7 ( 2.90 )
        Week 12, (n = 34, 33)
    -1.5 ( 1.84 )
    -5.1 ( 2.95 )
        Week 16, (34, 33)
    -1.7 ( 1.81 )
    -5.1 ( 3.00 )
        Week 18, (n = 34, 33)
    -1.8 ( 1.87 )
    -4.9 ( 3.07 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.9
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 -1.8
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -2
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -1.8
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 -2.3
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -2
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 -1.8

    Secondary: Percent change from Baseline in weekly average of the peak pruritus verbal rating scale (VRS) by timepoint using LOCF approach

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    End point title
    		 Percent change from Baseline in weekly average of the peak pruritus verbal rating scale (VRS) by timepoint using LOCF approach
    End point description
    The VRS, consisting of a list of adjectives describing different levels of symptom intensity, was used by-subjects to report the intensity of their pruritus (itch) during last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their worst itch during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -9.8 ( 14.24 )
    -27.6 ( 17.21 )
        Week 2, (n = 34, 32)
    -12.3 ( 17.64 )
    -39.1 ( 25.38 )
        Week 4, (n = 34, 32)
    -15.6 ( 20.95 )
    -50.7 ( 29.37 )
        Week 8, (n = 34, 32)
    -20.7 ( 21.22 )
    -54.3 ( 30.61 )
        Week 12, (n = 34, 32)
    -19.4 ( 23.60 )
    -56.9 ( 32.64 )
        Week 16, (n = 34, 32)
    -21.2 ( 22.24 )
    -55.6 ( 34.48 )
        Week 18, (n = 34, 32)
    -23.0 ( 21.97 )
    -53.4 ( 36.56 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.8
         upper limit
    		 -9.6
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.8
         upper limit
    		 -15.6
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47
         upper limit
    		 -21.9
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46
         upper limit
    		 -20.1
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -37.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.4
         upper limit
    		 -22.9
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48
         upper limit
    		 -19.2
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45
         upper limit
    		 -14.9

    Secondary: Absolute change from Baseline in weekly average of the peak pruritus VRS by timepoint using LOCF approach

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    End point title
    		 Absolute change from Baseline in weekly average of the peak pruritus VRS by timepoint using LOCF approach
    End point description
    The VRS, consisting of a list of adjectives describing different levels of symptom intensity, was used by-subjects to report the intensity of their pruritus (itch) during last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their worst itch during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -0.3 ( 0.47 )
    -0.9 ( 0.57 )
        Week 2, (n = 34, 32)
    -0.4 ( 0.61 )
    -1.3 ( 0.83 )
        Week 4, (n = 34, 32)
    -0.6 ( 0.74 )
    -1.6 ( 1.00 )
        Week 8, (n = 34, 32)
    -0.7 ( 0.74 )
    -1.8 ( 1.06 )
        Week 12, (n = 34, 32)
    -0.7 ( 0.83 )
    -1.8 ( 1.09 )
        Week 16, (n = 34, 32)
    -0.7 ( 0.78 )
    -1.8 ( 1.16 )
        Week 18, (n = 34, 32)
    -0.8 ( 0.77 )
    -1.7 ( 1.26 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.3
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.5
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.7
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.6
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -0.7
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.6
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.5

    Secondary: Dynamic pruritus score (DPS) at 24, 48, and 72 hours after first injection and before second injection (Week 4)

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    End point title
    		 Dynamic pruritus score (DPS) at 24, 48, and 72 hours after first injection and before second injection (Week 4)
    End point description
    The 9-point DPS scale was used by-subjects to evaluate the change of their pruritus compared with an earlier timepoint. The scale ranges from 0 (strongly worsened pruritus) to 8 ([almost] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    At 24, 48, and 72 hours (Baseline) and Week 4
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        First injection, after 24 hours (n=23,22)
    4.3 ( 0.96 )
    5.0 ( 1.20 )
        First injection, after 48 hours (n=22, 23)
    4.0 ( 1.69 )
    5.3 ( 1.40 )
        First injection, after 72 hours (n=25,24)
    4.0 ( 1.37 )
    5.7 ( 1.34 )
        Before Second Injection (Week 4) (n=30,32)
    4.4 ( 1.07 )
    6.3 ( 1.89 )
    Statistical analysis title
    		 First injection, after 24 hours
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 First injection, after 48 hours
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 First injection, after 72 hours
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Before Second Injection (Week 4)
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percent Change From Baseline in Prurigo Activity Score (PAS) Item 5 (Number of Lesions) at Week 12

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    End point title
    		 Percent Change From Baseline in Prurigo Activity Score (PAS) Item 5 (Number of Lesions) at Week 12
    End point description
    The PAS was used by the Investigator (or trained designee) to evaluate the disease.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
        number (not applicable)
    14.8
    35.4
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: PAS Item 6 (excoriation/crusts and healed lesions stages) at each visit

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    End point title
    		 PAS Item 6 (excoriation/crusts and healed lesions stages) at each visit
    End point description
    The PAS was used by the Investigator (or trained designee) to evaluate the disease.
    End point type
    Secondary
    End point timeframe
    At Day 1 (Baseline), Weeks 4, 8, 12, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Unit on a scale
    number (not applicable)
        Excoriations/crusts, Day 1 (Baseline), 0=0%
    0
    0
        Excoriations/crusts, Day 1 (Baseline), 1=1-25%
    2
    4
        Excoriations/crusts, Day 1 (Baseline), 2=26-50%
    7
    5
        Excoriations/crusts, Day 1 (Baseline), 3=51-75%
    14
    12
        Excoriations/crusts, Day 1 (Baseline), 4=76-100%
    13
    13
        Excoriations/crusts, Week 4, 0=0%
    2
    2
        Excoriations/crusts, Week 4, 1=1-25%
    6
    10
        Excoriations/crusts, Week 4, 2=26-50%
    7
    9
        Excoriations/crusts, Week 4, 3=51-75%
    10
    9
        Excoriations/crusts, Week 4, 4=76-100%
    9
    3
        Excoriations/crusts, Week 8, 0=0%
    2
    4
        Excoriations/crusts, Week 8, 1=1-25%
    5
    13
        Excoriations/crusts, Week 8, 2=26-50%
    7
    6
        Excoriations/crusts, Week 8, 3=51-75%
    11
    9
        Excoriations/crusts, Week 8, 4=76-100%
    7
    0
        Excoriations/crusts, Week 12, 0=0%
    1
    3
        Excoriations/crusts, Week 12, 1=1-25%
    7
    17
        Excoriations/crusts, Week 12, 2=26-50%
    5
    9
        Excoriations/crusts, Week 12, 3=51-75%
    12
    3
        Excoriations/crusts, Week 12, 4=76-100%
    5
    0
        Excoriations/crusts, Week 18, 0=0%
    1
    6
        Excoriations/crusts, Week 18, 1=1-25%
    4
    12
        Excoriations/crusts, Week 18, 2=26-50%
    8
    4
        Excoriations/crusts, Week 18, 3=51-75%
    11
    5
        Excoriations/crusts, Week 18, 4=76-100%
    6
    4
        Healed lesions, Day 1 (Baseline), 0=100%
    1
    0
        Healed lesions, Day 1 (Baseline), 1=75-99%
    0
    1
        Healed lesions, Day 1 (Baseline), 2=50-74%
    3
    5
        Healed lesions, Day 1 (Baseline), 3=25-49%
    13
    9
        Healed lesions, Day 1 (Baseline), 4=0-24%
    19
    19
        Healed lesions, Week 4, 0=100%
    2
    3
        Healed lesions, Week 4, 1=75-99%
    2
    5
        Healed lesions, Week 4, 2=50-74%
    6
    5
        Healed lesions, Week 4, 3=25-49%
    11
    14
        Healed lesions, Week 4, 4=0-24%
    13
    6
        Healed lesions, Week 8, 0=100%
    2
    3
        Healed lesions, Week 8, 1=75-99%
    3
    8
        Healed lesions, Week 8, 2=50-74%
    7
    8
        Healed lesions, Week 8, 3=25-49%
    9
    12
        Healed lesions, Week 8, 4=0-24%
    11
    1
        Healed lesions, Week 12, 0=100%
    1
    2
        Healed lesions, Week 12, 1=75-99%
    2
    9
        Healed lesions, Week 12, 2=50-74%
    7
    16
        Healed lesions, Week 12, 3=25-49%
    8
    5
        Healed lesions, Week 12, 4=0-24%
    12
    0
        Healed lesions, Week 18, 0=100%
    1
    3
        Healed lesions, Week 18, 1=75-99%
    2
    12
        Healed lesions, Week 18, 2=50-74%
    7
    7
        Healed lesions, Week 18, 3=25-49%
    8
    5
        Healed lesions, Week 18, 4=0-24%
    12
    4
    Statistical analysis title
    		 Statistical analysis for Week 4 Excoriation/crust
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 8 Excoriation/crust
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 12 Excoriation/crust
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 18 Excoriation/crust
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Day 1 Excoriation/crust
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.934
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Day 1 Healed lesions
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 4 Healed lesions
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 8 Healed lesions
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 12 Healed lesions
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 18 Healed lesions
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Investigator global assessment (IGA) of prurigo at each visit

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    End point title
    		 Investigator global assessment (IGA) of prurigo at each visit
    End point description
    IGA was used to evaluate the severity of the disease. The 5-point scale ranging from 0 (clear) to 4 (severe), rates the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    At Baseline and at Weeks 4, 8, 12, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 4, (n=35,33))
    3.3 ( 0.61 )
    2.8 ( 0.81 )
        Week 8, (n = 32, 32)
    3.1 ( 0.67 )
    2.4 ( 0.80 )
        Week 12, (n = 30, 32)
    2.8 ( 0.82 )
    2.0 ( 0.80 )
        Week 18, (n = 30, 31)
    3.0 ( 0.93 )
    2.0 ( 1.11 )
        Baseline (n = 36, 34)
    3.4 ( 0.49 )
    3.5 ( 0.51 )
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis for Baseline
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.156
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Proportion of subjects achieving IGA success (defined as IGA=0 [clear] or IGA=1 [Almost clear] with two-point improvement from Baseline) at Week 12

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    End point title
    		 Proportion of subjects achieving IGA success (defined as IGA=0 [clear] or IGA=1 [Almost clear] with two-point improvement from Baseline) at Week 12
    End point description
    IGA was to evaluate the severity of the disease. The 5-point scale ranging from 0 (clear) to 4 (severe), rates the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Subjects
        number (not applicable)
    1
    7
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 30.3

    Secondary: Percent change from Baseline in weekly average of the average pruritus NRS by timepoint, using LOCF approach

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    End point title
    		 Percent change from Baseline in weekly average of the average pruritus NRS by timepoint, using LOCF approach
    End point description
    To evaluate the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects with PN. The pruritus NRS was used by subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    Change from baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -7.5 ( 12.82 )
    -26.6 ( 21.25 )
        Week 2, (n = 34, 32)
    -9.6 ( 15.28 )
    -44.0 ( 29.54 )
        Week 4, (n = 34, 32)
    -16.5 ( 18.25 )
    -53.4 ( 33.23 )
        Week 8, (n = 34, 32)
    -24.6 ( 23.38 )
    -57.3 ( 34.78 )
        Week 12, (n = 34, 32)
    -23.0 ( 26.31 )
    -62.6 ( 34.98 )
        Week 16, (n = 34, 32)
    -25.9 ( 24.89 )
    -62.4 ( 35.93 )
        Week 18, (n = 34, 32)
    -26.2 ( 25.39 )
    -60.4 ( 36.15 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.2
         upper limit
    		 -9.8
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.7
         upper limit
    		 -22.6
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.2
         upper limit
    		 -23.1
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.6
         upper limit
    		 -17.3
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.8
         upper limit
    		 -24.1
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -35.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.3
         upper limit
    		 -20.6
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.6
         upper limit
    		 -18.2

    Secondary: Absolute change from Baseline in weekly average of the average pruritus NRS by timepoint, using LOCF approach

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    End point title
    		 Absolute change from Baseline in weekly average of the average pruritus NRS by timepoint, using LOCF approach
    End point description
    To evaluate the efficacy of nemolizumab compared to placebo in the treatment of pruritus in subjects with PN. The pruritus NRS was used by subjects to report the intensity of their pruritus (itch) during the last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being ‘worst itch imaginable’, how would they rate their itch at the worst moment during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    Change from baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -0.5 ( 0.82 )
    -1.9 ( 1.47 )
        Week 2, (n = 34, 32)
    -0.8 ( 1.14 )
    -3.2 ( 2.03 )
        Week 4, (n = 34, 32)
    -1.3 ( 1.41 )
    -3.9 ( 2.44 )
        Week 8, (n = 34, 32)
    -1.9 ( 1.80 )
    -4.2 ( 2.60 )
        Week 12, (n = 34, 32)
    -1.8 ( 2.05 )
    -4.6 ( 2.71 )
        Week 16, (n = 34, 32)
    -2.0 ( 1.97 )
    -4.6 ( 2.86 )
        Week 18, (n = 34, 32)
    -2.1 ( 2.02 )
    -4.5 ( 2.94 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -0.7
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 -1.6
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    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
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 -1.1
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 -1.7
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 -1.4
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 -1.2

    Secondary: Percent change from Baseline in weekly average of the average pruritus VRS by timepoint using LOCF approach

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    End point title
    		 Percent change from Baseline in weekly average of the average pruritus VRS by timepoint using LOCF approach
    End point description
    The VRS, consisting of a list of adjectives describing different levels of symptom intensity, was used by-subjects to report the intensity of their pruritus (itch) during last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their worst itch during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -10.5 ( 19.72 )
    -29.6 ( 16.90 )
        Week 2, (n = 34, 32)
    -13.0 ( 19.20 )
    -42.9 ( 24.22 )
        Week 4, (n = 34, 32)
    -16.4 ( 24.10 )
    -52.1 ( 27.63 )
        Week 8, (n = 34, 32)
    -23.5 ( 22.89 )
    -55.4 ( 30.63 )
        Week 12, (n = 34, 32)
    -21.9 ( 25.90 )
    -62.1 ( 29.98 )
        Week 16, (n = 34, 32)
    -25.1 ( 24.15 )
    -62.0 ( 32.48 )
        Week 18, (n = 34, 32)
    -26.2 ( 24.40 )
    -58.7 ( 34.81 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.7
         upper limit
    		 -9.5
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.2
         upper limit
    		 -18.8
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -35.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.1
         upper limit
    		 -22.4
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -31.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45
         upper limit
    		 -18.1
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.6
         upper limit
    		 -26.3
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50.1
         upper limit
    		 -22.1
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.1
         upper limit
    		 -17

    Secondary: Absolute change from Baseline in weekly average of the average pruritus VRS by timepoint using LOCF approach

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    End point title
    		 Absolute change from Baseline in weekly average of the average pruritus VRS by timepoint using LOCF approach
    End point description
    The VRS, consisting of a list of adjectives describing different levels of symptom intensity, was used by-subjects to report the intensity of their pruritus (itch) during last 24 hours. Subjects were asked the following questions in their local language: • For average itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their itch overall during the previous 24 hours; • For maximum itch intensity: On a scale of 0 to 4, with 0 being ‘no itch’ and 4 being ‘very severe itch’, how would they rate their worst itch during the previous 24 hours. n=number of subjects in analysis
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 1, 2, 4, 8, 12, 16, 18
    End point values
    		 Placebo Nemolizumab
    Number of subjects analysed
    36
    34
    Units: Percentage
    arithmetic mean (standard deviation)
        Week 1, (n = 33, 31)
    -0.4 ( 0.50 )
    -0.9 ( 0.49 )
        Week 2, (n = 34, 32)
    -0.4 ( 0.61 )
    -1.3 ( 0.68 )
        Week 4, (n = 34, 32)
    -0.6 ( 0.73 )
    -1.6 ( 0.84 )
        Week 8, (n = 34, 32)
    -0.7 ( 0.72 )
    -1.7 ( 0.96 )
        Week 12, (n = 34, 32)
    -0.7 ( 0.82 )
    -1.9 ( 0.94 )
        Week 16, (n = 34, 32)
    -0.8 ( 0.78 )
    -1.9 ( 1.06 )
        Week 18, (n = 34, 32)
    -0.8 ( 0.79 )
    -1.8 ( 1.16 )
    Statistical analysis title
    		 Statistical analysis for Week 1
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.3
    Statistical analysis title
    		 Statistical analysis for Week 2
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.5
    Statistical analysis title
    		 Statistical analysis for Week 4
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.6
    Statistical analysis title
    		 Statistical analysis for Week 8
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.5
    Statistical analysis title
    		 Statistical analysis for Week 12
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.7
    Statistical analysis title
    		 Statistical analysis for Week 16
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.6
    Statistical analysis title
    		 Statistical analysis for Week 18
    Comparison groups
    Placebo v Nemolizumab
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening until follow-up visit (up to Week 18)/early termination
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of matching placebo every 4 weeks (Q4W) (at Baseline, Week 4 & Week 8).

    Reporting group title
    Nemolizumab
    Reporting group description
    		 Each subject was randomized to receive three subcutaneous injections of 0.5 mg/kg of nemolizumab Q4W (at Baseline, Week 4 & Week 8).

    Serious adverse events
    		 Placebo Nemolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 36 (8.33%)
    4 / 34 (11.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema nummular
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fibromyalgia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Nemolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 36 (66.67%)
    23 / 34 (67.65%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    Pyrexia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Rubber sensitivity
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Dysphonia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Psychomotor retardation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Eye injury
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Post procedural inflammation
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Diastolic dysfunction
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Mitral valve incompetence
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Aerophagia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Dental caries
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 36 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    4
    Dermatitis contact
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Neurodermatitis
         subjects affected / exposed
    2 / 36 (5.56%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    Eczema
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Intertrigo
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Panniculitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    Rash papular
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Rosacea
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Polyuria
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    Spinal pain
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Groin pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 36 (11.11%)
    5 / 34 (14.71%)
         occurrences all number
    5
    5
    Conjunctivitis
         subjects affected / exposed
    2 / 36 (5.56%)
    3 / 34 (8.82%)
         occurrences all number
    2
    3
    Bronchitis
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Wound infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Erysipelas
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Periodontitis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Apr 2018
    Global amendment: ▪ Clarification regarding dosing was added throughout; ▪ The collection of NRS data between Screening Visit 2 and the Baseline Visit was clarified; ▪ For exclusion criterion 13, the text “immunosuppressive or immunomodulatory drugs (e.g., azathioprine, methotrexate, thalidomide, cyclosporine)” was expanded to include the drugs apremilast, hydroxychloroquine; ▪ Pharmacokinetics (PK) sampling time and PK sampling identification were further clarified for visits at Weeks 1, 2, 12, 16 and 18 because no injections were done at these visits; ▪ Fibrinogen was removed from blood sampling assessments.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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