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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis

    Summary
    EudraCT number
    		 2017-004210-25
    Trial protocol
    		 DE   AT   PL  
    Global end of trial date
    06 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2021
    First version publication date
    21 Jan 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MTI-106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03677401
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menlo Therapeutics Inc.
    Sponsor organisation address
    200 Cardinal Way, 2nd Floor, Redwood City, CA, United States, 94063
    Public contact
    Chief Scientific Officer, Menlo Therapeutics Inc., 1-800 775-7936, Iain.Stuart@foamix.com
    Scientific contact
    Chief Scientific Officer, Menlo Therapeutics Inc., 1-800 775-7936, Iain.Stuart@foamix.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
    22 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to assess the efficacy of serlopitant for the treatment of pruritus in adults with prurigo nodularis (PN), and to assess the safety and tolerability of repeated oral doses of serlopitant in adults with PN.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95) and with applicable local requirements. Prior to the performance of any study-specific procedure, written informed consent was obtained from each subject. The subject was informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that the subject could withdraw from the study at any time and for any reason, and that this would not have any effect on his/her potential future medical care. Representative written information given to the subject and a sample of the Independent Ethics Committee/Institutional Review Board-approved consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Aug 2018
    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
    European Union: 295
    Worldwide total number of subjects
    295
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    196
    From 65 to 84 years
    97
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter study was conducted from 29 August 2018 to 06 February 2020.

    Pre-assignment
    Screening details
    		 During the screening period (4 weeks), all subjects were evaluated for eligibility and chronic pruritic conditions frequently associated with PN. Subjects were to complete an electronic diary (eDiary) at the Screening visit.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were randomized to receive once-daily oral doses of placebo for 10 weeks.

    Arm title
    		 Serlopitant 5 mg
    Arm description
    		 Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10- week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selopitant 5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were randomized to receive once-daily oral doses of serlopitant 5 mg for 10 weeks.

    Number of subjects in period 1
    		Placebo Serlopitant 5 mg
    Started
    148
    147
    Completed
    138
    129
    Not completed
    10
    18
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    4
    14
         Reason unspecified
    1
    -
         Sponsor decision
    -
    1
         Lack of efficacy
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.

    Reporting group title
    Serlopitant 5 mg
    Reporting group description
    		 Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10- week treatment period.

    Reporting group values
    		 Placebo Serlopitant 5 mg Total
    Number of subjects
    		 148 147 295
    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)
    		 58.5 ( 12.97 ) 57.5 ( 15.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 94 98 192
        Male
    		 54 49 103
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 2 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 0 2
        White
    		 145 145 290
        More than one race
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.

    Reporting group title
    Serlopitant 5 mg
    Reporting group description
    		 Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10- week treatment period.

    Primary: Percent of Subjects With Worst Itch Numeric Rating Scale (WINRS) 4-point Responder Rate at Week 10

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    End point title
    		 Percent of Subjects With Worst Itch Numeric Rating Scale (WINRS) 4-point Responder Rate at Week 10
    End point description
    During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from Baseline in weekly average WI-NRS at Week 10.
    End point type
    Primary
    End point timeframe
    At Week 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Percentage of subjects
    number (not applicable)
        Success
    18.95
    25.90
        Failure
    81.05
    74.10
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.158
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.

    Secondary: Percent of Subjects With WI-NRS 4-point Responder Rate at Week 4

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    End point title
    		 Percent of Subjects With WI-NRS 4-point Responder Rate at Week 4
    End point description
    During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from Baseline in weekly average WI-NRS at Week 10.
    End point type
    Secondary
    End point timeframe
    At Week 4
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Percentage of subjects
    number (not applicable)
        Success
    11.49
    12.63
        Failure
    88.51
    87.37
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 4
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.75
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.

    Secondary: Percent of Subjects With WI-NRS 4-point Responder Rate at Week 2

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    End point title
    		 Percent of Subjects With WI-NRS 4-point Responder Rate at Week 2
    End point description
    During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from Baseline in weekly average WI-NRS at Week 10.
    End point type
    Secondary
    End point timeframe
    At Week 2
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Percentage of Subjects
    number (not applicable)
        Success
    6.76
    5.55
        Failure
    93.24
    94.45
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 2
    Comparison groups
    Serlopitant 5 mg v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.674
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.

    Secondary: Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10

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    End point title
    		 Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
    End point description
    During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 6, and 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Score on a scale
    least squares mean (standard deviation)
        Change from Baseline at Week 2
    -0.94 ( 1.470 )
    -1.25 ( 1.496 )
        Change from Baseline at Week 4
    -1.42 ( 1.908 )
    -1.60 ( 1.955 )
        Change from Baseline at Week 6
    -1.61 ( 2.105 )
    -1.93 ( 2.182 )
        Change from Baseline at Week 10
    -1.86 ( 2.334 )
    -2.24 ( 2.543 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 2
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.06
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    At Week 4
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.401
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    At Week 6
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.185
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.164
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.

    Secondary: Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10

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    End point title
    		 Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
    End point description
    During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they at least 3-point reduction from Baseline in weekly average WI-NRS.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, and 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Percentage of subjects
    number (not applicable)
        Percentage of responders at Week 2
    8.11
    11.89
        Percentage of responders at Weel 4
    18.24
    20.03
        Percentage of responders at Weel 10
    25.65
    37.58
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 2
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.283
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    At Week 4
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.701
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.033
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
    End point description
    Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
    End point type
    Secondary
    End point timeframe
    At Week 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Score on a scale
        least squares mean (standard deviation)
    -4.4 ( 5.07 )
    -4.5 ( 5.14 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.797
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [11] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.

    Secondary: Change From Baseline in DLQI Question 1 to Week 10

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    End point title
    		 Change From Baseline in DLQI Question 1 to Week 10
    End point description
    DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
    End point type
    Secondary
    End point timeframe
    At Week 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Score on a scale
        least squares mean (standard deviation)
    -0.6 ( 0.75 )
    -0.6 ( 0.76 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.845
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [12] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.

    Secondary: Change From Baseline in Investigator’s Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10

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    End point title
    		 Change From Baseline in Investigator’s Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10
    End point description
    The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4 and 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Score on a scale
    least squares mean (standard deviation)
        Change from Baseline at Week 2
    -0.2 ( 0.43 )
    -0.2 ( 0.43 )
        Change from Baseline at Week 4
    -0.4 ( 0.64 )
    -0.3 ( 0.64 )
        Change from Baseline at Week 10
    -0.5 ( 0.77 )
    -0.5 ( 0.78 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 2
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.385
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [13] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    At Week 4
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 = 0.786
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [14] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.502
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [15] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.

    Secondary: Change From Baseline in Investigator’s Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10

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    End point title
    		 Change From Baseline in Investigator’s Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
    End point description
    The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, and 10
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Score on a scale
    least squares mean (standard deviation)
        Change from Baseline at Week 2
    -0.2 ( 0.49 )
    -0.3 ( 0.49 )
        Change from Baseline at Week 4
    -0.5 ( 0.68 )
    -0.5 ( 0.68 )
        Change from Baseline at Week 10
    -0.7 ( 0.91 )
    -0.7 ( 0.92 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    At Week 2
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [16]
    P-value
    		 = 0.197
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [16] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    At Week 4
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.694
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [17] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    At Week 10
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 = 0.916
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [18] - P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAEs)
    End point description
    Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
    End point type
    Secondary
    End point timeframe
    From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early
    End point values
    		 Placebo Serlopitant 5 mg
    Number of subjects analysed
    148
    147
    Units: Subjects
        Subjects with any TEAE
    87
    84
        Subjects with any related TEAE
    24
    30
        Subjects with any serious TEAE
    2
    5
        Subjects who died
    0
    0
        Subjects who discontinued study drug
    4
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
    Adverse event reporting additional description
    AEs and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.

    Reporting group title
    Serlopitant 5 mg
    Reporting group description
    		 Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10- week treatment period.

    Serious adverse events
    		 Placebo Serlopitant 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 148 (1.35%)
    5 / 147 (3.40%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Musculoskeletal and connective tissue disorders
    Crystal arthropathy
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 147 (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: 5%
    Non-serious adverse events
    		 Placebo Serlopitant 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 148 (22.30%)
    30 / 147 (20.41%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 148 (4.05%)
    10 / 147 (6.80%)
         occurrences all number
    8
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 148 (4.05%)
    12 / 147 (8.16%)
         occurrences all number
    6
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    23 / 148 (15.54%)
    17 / 147 (11.56%)
         occurrences all number
    25
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Mar 2019
    V 3.0: - Removed two key secondary efficacy endpoints - Increased study population to 280 subjects - Added optional interim analysis
    16 Dec 2019
    V 4.0: - Removed ‘Change from Baseline in Dermatology Life Quality Index (DLQI) to Week 10'; Added ‘WI-NRS 4-point responder rate at Week 2’ - Removed ‘WI-NRS 4-point responder rate at Week 2’; Added ‘Change from Baseline in DLQI to Week 10’; Added ‘Change from Baseline in DLQI Question 1 to Week 10’ - Removed ‘Change from Baseline in DLQI to Week 10’; Added ‘WI-NRS 4-point responder rate at Week 2’ - Changed the minimum number of observations needed to compute a week’s average of WI-NRS from 1 observation to 4 observations; Removed the explanation for handling missing Week 10 DLQI data; Updated the number of random seeds needed to impute missing data - Removed ‘Change from Baseline in DLQI to Week 10’; Added ‘WI-NRS 4-point responder rate at Week 2’; Removed information regarding the ANCOVA model - Added information regarding the analysis of the secondary endpoints - Removed ‘Graphs of laboratory values over time will also be produced.’

    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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