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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Study of the Neurokinin-1 Receptor Antagonist VPD-737 [Serlopitant] in Subjects with Prurigo Nodularis

    Summary
    EudraCT number
    		 2013-005024-42
    Trial protocol
    		 DE   IE   PL  
    Global end of trial date
    10 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2020
    First version publication date
    30 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCP-102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menlo Therapeutics Inc. (formerly Tigercat Pharma, Inc.)
    Sponsor organisation address
    4085 Campbell Avenue, Suite 200, Menlo Park, CA, United States, 94025
    Public contact
    Iain Stuart, PhD, Menlo Therapeutics, Inc., 1- 800-775-7936, Iain.Stuart@foamix.com
    Scientific contact
    Iain Stuart, PhD, 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
    31 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were to evaluate the efficacy and safety of Serlopitant 5 mg tablets and placebo taken orally once daily for 8 weeks for the treatment of prurigo nodularis (PN).
    Protection of trial subjects
    The protocol, proposed informed consent form(s), and other information for subjects was reviewed and approved by central and local Ethics Committees (ECs) before the start of the trial, in compliance with local regulations. This study was conducted in compliance with the protocol and the applicable laws and regulatory requirements of Germany in which the study was conducted. The study was conducted in accordance with the ethical principles originating from the Declaration of Helsinki and amendments and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. The investigator explained to each subject the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits involved, and any discomfort it might entail. Each subject was informed that participation in the study was voluntary, that he/she could withdraw from the study at any time, and that withdrawal of consent would not affect his/her subsequent medical treatment or relationship with the treating physician. No subject could enter the study before informed consent had been obtained from him/her, or his/her legally authorized representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 127
    Worldwide total number of subjects
    127
    EEA total number of subjects
    127
    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)
    88
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were randomized at 15 sites in Germany. Of the 128 subjects who were randomized, 127 received study drug.

    Pre-assignment
    Screening details
    		 This study consisted of a screening period of up to 4 weeks. All the assessments were done at screening as per the schedule of assessment. One subject was randomized to Serlopitant but, due to an exacerbation of pruritus, received systemic cyclosporine treatment that was an exclusion criterion and therefore the subject never received study drug.

    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 as a double-blind study with the treatment assignment concealed from the subjects, the investigator(s) and their staff, and the clinical research team. The placebo was formulated to be indistinguishable from the active study product. Study materials were packaged and issued in a manner designed to maintain the blind for subjects and all study personnel involved in the direction and execution of study procedures, study assessments, and collection of data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Randomized subjects took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
    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
    Matching placebo tablets for oral administration were taken orally as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime.

    Arm title
    		 Serlopitant
    Arm description
    		 Randomized subjects took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Serlopitant
    Investigational medicinal product code
    VPD-737
    Other name
    Neurokinin-1 Receptor Antagonist VPD-737
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Serlopitant 5 mg tablets for oral administration were taken orally as a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime.

    Number of subjects in period 1
    		Placebo Serlopitant
    Started
    63
    64
    Completed
    48
    57
    Not completed
    15
    7
         Consent withdrawn by subject
    8
    4
         Other
    1
    -
         Adverse Event or Serious Adverse Event
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Reporting group title
    Serlopitant
    Reporting group description
    		 Randomized subjects took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Reporting group values
    		 Placebo Serlopitant Total
    Number of subjects
    		 63 64 127
    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)
    		 58.1 ( 11.14 ) 57.1 ( 12.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 31 67
        Male
    		 27 33 60

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Reporting group title
    Serlopitant
    Reporting group description
    		 Randomized subjects took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Primary: Average Visual Analog Scale (VAS)

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    End point title
    		 Average Visual Analog Scale (VAS)
    End point description
    At study visits, subjects recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of “no itch” (0 cm) and worst imaginable itch” (10 cm). Average VAS (average itch over the past 24 hours) was recorded. n= number of subjects analyzed
    End point type
    Primary
    End point timeframe
    At Baseline, Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 63, 64)
    7.92 ( 1.630 )
    7.88 ( 1.311 )
        Week 2 (n = 61, 63)
    7.01 ( 2.187 )
    6.06 ( 2.236 )
        Week 4 (n = 54, 64)
    6.32 ( 2.403 )
    5.41 ( 2.719 )
        Week 8 (n = 46, 57)
    5.56 ( 2.630 )
    4.21 ( 2.746 )
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Statistics for Repeated Measures of Change From Baseline
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0111
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Repeated Measures of Change from Baseline
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0248
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Repeated Measures of Change from Baseline
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.47

    Secondary: Verbal Rating Scale (VRS) - pruritus

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    End point title
    		 Verbal Rating Scale (VRS) - pruritus
    End point description
    At study visits, subjects used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present).
    End point type
    Secondary
    End point timeframe
    At Baseline and Week 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Baseline (n=62,64) Mild Present
    2
    0
        Baseline (n=62,64) Moderately Present
    18
    17
        Baseline (n=62,64) Severely Present
    20
    32
        Baseline (n=62,64) Very Severely Present
    22
    15
        Week 8 (n=45, 57) Not Present
    2
    4
        Week 8 (n=45, 57) Mild Present
    11
    27
        Week 8 (n=45, 57) Moderately Present
    18
    17
        Week 8 (n=45, 57) Severely Present
    9
    7
        Week 8 (n=45, 57) Very Severely Present
    5
    2
    No statistical analyses for this end point

    Secondary: Verbal Rating Scale (VRS) - Burning

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    End point title
    		 Verbal Rating Scale (VRS) - Burning
    End point description
    At study visits, subjects used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present).
    End point type
    Secondary
    End point timeframe
    At Baseline and Week 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Baseline (n=62,64) Not Present
    14
    21
        Baseline (n=62,64) Mild Present
    8
    5
        Baseline (n=62,64) Moderately Present
    13
    21
        Baseline (n=62,64) Severely Present
    18
    12
        Baseline (n=62,64) Very Severely Present
    9
    5
        Week 8 (n=43, 56) Not Present
    11
    31
        Week 8 (n=43, 56) Mild Present
    9
    10
        Week 8 (n=43, 56) Moderately Present
    15
    8
        Week 8 (n=43, 56) Severely Present
    5
    6
        Week 8 (n=43, 56) Very Severely Present
    3
    1
    No statistical analyses for this end point

    Secondary: Verbal Rating Scale (VRS) - Stinging

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    End point title
    		 Verbal Rating Scale (VRS) - Stinging
    End point description
    At study visits, subjects used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present).
    End point type
    Secondary
    End point timeframe
    At Baseline and Week 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Baseline (n=62,64) Not Present
    26
    21
        Baseline (n=62,64) Mild Present
    8
    14
        Baseline (n=62,64) Moderately Present
    11
    16
        Baseline (n=62,64) Severely Present
    9
    10
        Baseline (n=62,64) Very Severely Present
    8
    3
        Week 8 (n=43, 54) Not Present
    18
    30
        Week 8 (n=43, 54) Mild Present
    8
    12
        Week 8 (n=43, 54) Moderately Present
    10
    7
        Week 8 (n=43, 54) Severely Present
    4
    4
        Week 8 (n=43, 54) Very Severely Present
    3
    1
    No statistical analyses for this end point

    Secondary: Worst Visual Analog Scale (VAS)

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    End point title
    		 Worst Visual Analog Scale (VAS)
    End point description
    At study visits, subjects recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of “no itch” (0 cm) and worst imaginable itch” (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded.
    End point type
    Secondary
    End point timeframe
    At Baseline, Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n=63, 64)
    8.75 ( 1.316 )
    8.43 ( 1.190 )
        Week 2 (n=61, 63)
    7.92 ( 1.733 )
    6.85 ( 2.157 )
        Week 4 (n= 54, 64)
    7.46 ( 2.285 )
    6.19 ( 2.690 )
        Week 8 (n= 46, 57)
    6.73 ( 2.591 )
    4.82 ( 2.729 )
    No statistical analyses for this end point

    Secondary: Patient Global Assessment (PGA)

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    End point title
    		 Patient Global Assessment (PGA)
    End point description
    The PGA included a global question and dynamic sub-questions: (1) Did the pruritus improve during the treatment period (yes/no) (2) If yes, for how long (some minutes/some hours/some days) (3) If yes relieved, to what extent o 1%-30% (no or weak improvement) o 31%-50% (moderate improvement) o 51%-70% (good improvement) o 71%-100% (very good improvement) (4) Can you say it [the percentage improvement] exactly (___%).
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Percentage of Subjects
    number (not applicable)
        Week 2
    37.7
    58.7
        Week 4
    53.7
    67.2
        Week 8
    54.3
    82.5
    No statistical analyses for this end point

    Secondary: Numeric Rating Scale (NRS)

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    End point title
    		 Numeric Rating Scale (NRS)
    End point description
    Numeric Rating Scale: Using the patient diary, subjects rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): (1) average itching over the past 24 hours (Average NRS).
    End point type
    Secondary
    End point timeframe
    At Baseline, Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n=48, 48)
    7.65 ( 1.669 )
    7.60 ( 1.455 )
        Week 2 (n=58,62)
    6.23 ( 2.043 )
    5.50 ( 1.944 )
        Week 4 (n=52,62)
    5.80 ( 2.133 )
    4.91 ( 2.158 )
        Week 8 (n=46,54)
    5.11 ( 2.320 )
    4.02 ( 2.190 )
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 0
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -0.1
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0175 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.2
    Notes
    [1] - p-value assume equal variance

    Secondary: Dermatology Life Quality Index (DLQI)

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    End point title
    		 Dermatology Life Quality Index (DLQI)
    End point description
    At each visit, subjects completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the subject’s skin condition affected his/her daily activities.
    End point type
    Secondary
    End point timeframe
    At Baseline, Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n=61,61)
    14.9 ( 7.03 )
    13.7 ( 6.76 )
        Week 2 (n=57,62)
    12.4 ( 6.94 )
    11.6 ( 6.20 )
        Week 4 (n=51,62)
    11.6 ( 6.56 )
    11.4 ( 6.80 )
        Week 8 (n=44,55)
    11.3 ( 6.83 )
    10.6 ( 7.31 )
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 1.6
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 2.3
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 2.1

    Secondary: Pruritus-specific Quality of Life (ItchyQoL)

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    End point title
    		 Pruritus-specific Quality of Life (ItchyQoL)
    End point description
    At each visit, subjects completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to patients with pruritus.
    End point type
    Secondary
    End point timeframe
    At Baseline, Weeks 2, 4, and 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n=63,64)
    3.68 ( 0.737 )
    3.52 ( 0.679 )
        Week 2 (n=61,63)
    3.50 ( 0.795 )
    3.36 ( 0.670 )
        Week 4 (n=54,64)
    3.36 ( 0.863 )
    3.26 ( 0.730 )
        Week 8 (n=46,57)
    3.33 ( 0.876 )
    3.09 ( 0.904 )
    Statistical analysis title
    		 Week 2
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.1
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    Observed results)
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.2
    Statistical analysis title
    		 Week 8
    Statistical analysis description
    Observed results
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1

    Secondary: Patient Benefit Index, Version for Patients with Pruritus (PBI-P)

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    End point title
    		 Patient Benefit Index, Version for Patients with Pruritus (PBI-P)
    End point description
    At Visits 2 and 5 (or Early termination) only, subjects completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual subject. After treatment, using the Patient Benefit Questionnaire (PBQ), subjects were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient-relevant therapy benefits.
    End point type
    Secondary
    End point timeframe
    At Week 8 / End of Treatment
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    61
    63
    Units: Unit on a scale
        arithmetic mean (standard deviation)
    0.81 ( 0.984 )
    1.16 ( 1.095 )
    Statistical analysis title
    		 Week 8 / End of Treatment
    Comparison groups
    Placebo v Serlopitant
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0625 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.72
    Notes
    [2] - p-value assume equal variance.

    Secondary: Investigator Global Assessment (IGA)

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    End point title
    		 Investigator Global Assessment (IGA)
    End point description
    Using the IGA, physicians rated change in PN lesions (if any) from +5 (“markedly improved”) to -5 (“markedly worse”).
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    47
    57
    Units: Subjects
    number (not applicable)
        Markedly Improved
    0
    4
        Largely Improved
    2
    3
        Moderately To Largely Improved
    4
    3
        Moderately Improved
    4
    11
        Mildly Improved
    9
    17
        Baseline
    14
    7
        Mildly Worse
    8
    5
        Moderately Worse
    4
    4
        Moderately To Largely Worse
    1
    1
        Largely Worse
    1
    2
    No statistical analyses for this end point

    Secondary: Prurigo Activity Score (PAS)

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    End point title
    		 Prurigo Activity Score (PAS)
    End point description
    Using the PAS, physicians described, localized, counted, and measured PN lesions. The PAS was assessed at Visit 2 (Baseline), 3 (Week 2), 4 (Week 4), and 5 (Week 8) (or at Early termination). The 7 items were: 1) Type of PN lesion a. Which efflorescences do you see? (6 possible responses) b. Which type of prurigo is predominant? (6 possible responses) 2) Number of PN lesions (0, 1-19, 20-100, > 100) 3) Distribution (disseminated, localized, neither) 4) Affected areas (14 possible responses) 5) Lesions in the representative area (continuous variable) and the location of this area. 6) Lesion size (elevation, longitudinal, crosswise) a. Biggest prurigo lesion b. Representative prurigo lesion 7) Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = > 75%) a. Prurigo lesions with excoriations/crusts b. Healed prurigo lesions PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Week 8
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Day 1 (n=63,64) 1 - 25 %
    7
    5
        Day 1 (n=63,64) 26 - 50 %
    18
    19
        Day 1 (n=63,64) 51 - 75 %
    17
    19
        Day 1 (n=63,64) >75 %
    21
    21
        Week 8 (n=47,57) 0 %
    0
    4
        Week 8 (n=47,57) 1 - 25 %
    11
    15
        Week 8 (n=47,57) 26 - 50 %
    12
    12
        Week 8 (n=47,57) 51 - 75 %
    11
    11
        Week 8 (n=47,57) >75 %
    13
    15
    No statistical analyses for this end point

    Secondary: Rescue medication usage

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    End point title
    		 Rescue medication usage
    End point description
    Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
    End point type
    Secondary
    End point timeframe
    8 Weeks
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Pre-treatment Rescue Medication Used
    15
    17
        Used Rescue Medication
    12
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs)

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    End point title
    		 Number of subjects with adverse events (AEs)
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality.
    End point type
    Secondary
    End point timeframe
    From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
    End point values
    		 Placebo Serlopitant
    Number of subjects analysed
    63
    64
    Units: Subjects
    number (not applicable)
        Adverse events (AEs)
    91
    102
        Subjects with AEs
    39
    46
        Treatment-emergent adverse events (TEAEs)
    91
    102
        Subjects with TEAEs
    39
    46
        Subjects with TEAEs leading to discontinuation
    6
    3
        Subjects with TEAEs related to study drug
    22
    31
        Subjects with TEAEs by maximum severity, Mild
    14
    18
        Subjects with TEAEs by maximum severity, Moderate
    22
    22
        Subjects with TEAEs by maximum severity, Severe
    3
    6
        Subjects with serious TEAEs
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized subjects took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Reporting group title
    Serlopitant
    Reporting group description
    		 Randomized subjects took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

    Serious adverse events
    		 Placebo Serlopitant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 64 (4.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (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
    Actinic elastosis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 63 (31.75%)
    31 / 64 (48.44%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 64 (6.25%)
         occurrences all number
    1
    4
    Headache
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 64 (6.25%)
         occurrences all number
    4
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 63 (6.35%)
    6 / 64 (9.38%)
         occurrences all number
    4
    6
    Oedema peripheral
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 64 (6.25%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 63 (4.76%)
    7 / 64 (10.94%)
         occurrences all number
    3
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    7 / 63 (11.11%)
    3 / 64 (4.69%)
         occurrences all number
    7
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 63 (3.17%)
    11 / 64 (17.19%)
         occurrences all number
    3
    11
    Urinary tract infection
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 64 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2014
    Subjects were first screened under Version 3.0 of the protocol (26 May 2014). Protocol Version 4.0 specified that efficacy analysis would be on the intent-to-treat (ITT) population.
    19 Sep 2014
    Protocol Version 5.0 Shortened the washout periods to 2 weeks for systemic prior therapies, 1 week for topical therapies, and 5 days for antihistamines. The additional review according to the Common Terminology Criteria for Adverse Events (CTCAE) of AEs previously classified as moderate toxicity or higher was deleted as those criteria are specified for cancer indications.  As fluconazole was classified as a strong CYP3A4 inhibitor in the exclusion criteria, it was deleted in the section describing co-administration of weak and moderate CYP3A4 inhibitors.
    16 Apr 2015
    Protocol Version 6.0 The sample size, which was originally based on clinical judgment, was revised based on statistical estimates obtained on data from a recently completed study in pruritus. The total sample size was doubled to detect a statistically significant difference between treatment groups. Accordingly, the planned number of trial sites was increased and the estimated trial period was extended. The shelf-life extension and subsequent re-labelling of the study drug were added.
    16 Jun 2015
    Protocol Version 7.0 Originally, subjects who were at least 18 and no more than 75 years of age at screening were eligible for study entry. The maximum age was increased to no more than 80 years.

    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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