<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02196324</url>
  </required_header>
  <id_info>
    <org_study_id>TCP-102</org_study_id>
    <nct_id>NCT02196324</nct_id>
  </id_info>
  <brief_title>A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Study of Neurokinin-1 Receptor Antagonist Serlopitant in Subjects With Prurigo Nodularis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vyne Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vyne Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor&#xD;
      antagonist is safe and effective for treatment of prurigo nodularis versus placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sensation of itch is transmitted to the brain through the nervous system. Several&#xD;
      chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat&#xD;
      this condition by blocking one of the chemicals involved in the transmission of the itch&#xD;
      signal. This is an oral drug administered once daily It has been used in other trials and has&#xD;
      shown to be safe at the doses used in this trial. The trial will involve once daily pills for&#xD;
      8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper&#xD;
      during the study period. Patients will also be monitored for safety and will have blood taken&#xD;
      for testing and several points during the trial. Overall participation will last about 14&#xD;
      weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2014</start_date>
  <completion_date type="Actual">June 10, 2016</completion_date>
  <primary_completion_date type="Actual">May 27, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Visual Analog Scale at Baseline</measure>
    <time_frame>At Baseline</time_frame>
    <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Visual Analog Scale at Week 2</measure>
    <time_frame>At Week 2</time_frame>
    <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Visual Analog Scale at Week 4</measure>
    <time_frame>At Week 4</time_frame>
    <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Visual Analog Scale at Week 8</measure>
    <time_frame>At Week 8</time_frame>
    <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus</measure>
    <time_frame>At Baseline and Week 8</time_frame>
    <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning</measure>
    <time_frame>At Baseline and Week 8</time_frame>
    <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging</measure>
    <time_frame>At Baseline and Week 8</time_frame>
    <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst Visual Analog Scale (VAS)</measure>
    <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
    <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)</measure>
    <time_frame>At Weeks 2, 4, and 8</time_frame>
    <description>The PGA included a question: Did the pruritus improve during the treatment period (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS)</measure>
    <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
    <description>Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
    <description>At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.&#xD;
The scoring of each question is as follows:&#xD;
Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.&#xD;
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.&#xD;
Interpreting the DLQI Scores:&#xD;
0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus-specific Quality of Life (ItchyQoL)</measure>
    <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
    <description>At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.&#xD;
Items should be scored for the following answers:&#xD;
Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Benefit Index, Version for Patients With Pruritus (PBI-P)</measure>
    <time_frame>At Week 8 / End of Treatment</time_frame>
    <description>At Visits 2 and 5 (or Early termination) only, participants 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 participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants 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. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;does/did not apply to me&quot; = 5; and missing value = -9. Higher scores indicated better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)</measure>
    <time_frame>At Week 8</time_frame>
    <description>Using the IGA, physicians rated change in PN lesions (if any) from +5 (&quot;markedly improved&quot;) to -5 (&quot;markedly worse&quot;). Higher scores indicated better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement on Prurigo Activity Score (PAS)</measure>
    <time_frame>At Day 1 and Week 8</time_frame>
    <description>Using the PAS, physicians described, localized, counted, and measured PN lesions.&#xD;
One of the 7 items was:&#xD;
Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = &gt; 75%)&#xD;
a. Prurigo lesions with excoriations/crusts&#xD;
Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Rescue Medication Usage</measure>
    <time_frame>Pre-treatment, upto 8 Weeks</time_frame>
    <description>Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Prurigo Nodularis</condition>
  <arm_group>
    <arm_group_label>serlopitant 5 mg tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>serlopitant 5 mg tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>serlopitant</intervention_name>
    <description>NK1 receptor antagonist</description>
    <arm_group_label>serlopitant 5 mg tablets</arm_group_label>
    <other_name>VPD-737</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting all of the following criteria will be eligible for study entry:&#xD;
&#xD;
               1. Males or females who are at least 18 years and no more than 80 years of age at&#xD;
                  Screening.&#xD;
&#xD;
               2. Must have PN (defined as the presence of pruritic nodules due to chronic&#xD;
                  pruritus,) of more than 6 weeks duration despite treatment with current therapies&#xD;
                  such as antihistamines or corticosteroids (&quot;treatment resistant&quot; PN).&#xD;
&#xD;
               3. Must have PN lesions on both arms, both legs, and/or the trunk (ie, the lesions&#xD;
                  must not be localized).&#xD;
&#xD;
               4. Must have a VAS pruritus score of 70 or greater within 72 hours of Baseline.&#xD;
&#xD;
               5. Males, non-fecund females (ie, surgically sterilized, if procedure was done 12&#xD;
                  months before screening or subject is postmenopausal, without menses for 12&#xD;
                  months before screening), or females of childbearing potential using an&#xD;
                  acceptable method of birth control for a period of 35 days before the first&#xD;
                  dosing, and all females must have a negative pregnancy test at the screening and&#xD;
                  baseline visits:&#xD;
&#xD;
                  Note 1: Acceptable methods of birth control include any one of the following:&#xD;
&#xD;
                  abstinence, vasectomized sexual partner, hormonal methods (ie, birth-control&#xD;
                  pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device&#xD;
                  [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical&#xD;
                  cap, or condom with spermicidal jelly or foam. Subjects using oral contraceptives&#xD;
                  must also use a reliable backup method of birth control during the study and&#xD;
                  until the first menses after the last dose of study medication or for 14 days&#xD;
                  menses after the last dose of study medication.&#xD;
&#xD;
               6. Willing and able to understand and provide written informed consent.&#xD;
&#xD;
               7. Willing and able to comply with study requirements and restrictions including the&#xD;
                  discontinuation of all current therapies for pruritus.&#xD;
&#xD;
               8. Subjects must be in good health as determined by medical history, physical&#xD;
                  examination, and results of Electro Cardio Gram (ECG) and clinical laboratory&#xD;
                  tests (including urinalysis).&#xD;
&#xD;
               9. Agreeing to confidential use and storage of all data and use of all anonymized&#xD;
                  data for publication including scientific publication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects not eligible for the study are those who:&#xD;
&#xD;
          -  Have chronic pruritus due conditions other than PN, such as the following conditions:&#xD;
&#xD;
          -  Lichen simplex chronicus&#xD;
&#xD;
          -  Lichen amyloidosus&#xD;
&#xD;
          -  Localized pruritus (e.g., only one arm affected)&#xD;
&#xD;
          -  Neuropathic and psychogenic pruritus (notalgia paresthetica, brachioradial pruritus,&#xD;
             somatoform prurigo, dilusional parasitosis, depression associated prurigo)&#xD;
&#xD;
          -  Active dermatoses needing immediate therapy such as atopic dermatitis (without PN) or&#xD;
             bullous pemphigoid;&#xD;
&#xD;
          -  Have a history of use (within the specified time periods) of the medications listed&#xD;
             below. Prior to randomization, a subject who used any of these medications must&#xD;
             undergo a washout period equal to the length of the interval specified below (eg, 2&#xD;
             weeks for antihistamines, 4 weeks for naltrexone, and 4 weeks for cyclosporine A).&#xD;
&#xD;
          -  Topical or systemic antihistamines, (used ≤2 weeks prior to the baseline visit)&#xD;
             [loratindine, or cetirizine may act as rescue medication during treatment];&#xD;
&#xD;
          -  Topical calcineurin inhibitors, topical capsaicin, menthol, camphor, polidocanol,&#xD;
             topical antibiotics, antiseptic baths and cleansing lotions (used ≤2 weeks prior to&#xD;
             the baseline visit);&#xD;
&#xD;
          -  Topical steroids (used ≤2 weeks prior to the baseline visit);&#xD;
&#xD;
          -  Naltrexone, paroxetine, fluvoxamine, amitriptyline, gabapentin, pregabalin, or&#xD;
             UVtherapy (prescribed for the pruritus treatment) (used ≤4 weeks prior to the baseline&#xD;
             visit);&#xD;
&#xD;
          -  Systemic steroids (used ≤4 weeks prior to the baseline visit);&#xD;
&#xD;
          -  Cyclosporine A and other immunosuppressants (used ≤4 weeks prior to the baseline&#xD;
             visit).&#xD;
&#xD;
          -  Have any medical condition or disability that would interfere with the assessment of&#xD;
             safety or efficacy in this trial or would compromise the ability of the subject to&#xD;
             undergo study procedures or to give informed consent.&#xD;
&#xD;
          -  Have any chronic or acute medical condition that, in the opinion of the investigator,&#xD;
             might interfere with the study results or place the subject at undue risk.&#xD;
&#xD;
          -  Have a history of sensitivity to any components of the study material.&#xD;
&#xD;
          -  Are females of childbearing potential who are unwilling to use adequate contraception&#xD;
             or who are breast feeding.&#xD;
&#xD;
          -  Have chronic renal disease, ie, serum creatinine greater than 2.4 mg/dL.&#xD;
&#xD;
          -  Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2&#xD;
             times the upper limit of normal. Subjects with hepatitis B or C who have normal liver&#xD;
             function may be enrolled.&#xD;
&#xD;
          -  Have a current malignancy (such as Hodgkin's lymphoma, B or T cell lymphoma, or&#xD;
             myeloma) or blood cell dyscrasia (eg, polycythemia or myelofibrosis) that might lead&#xD;
             to systemic chronic pruritus.&#xD;
&#xD;
          -  Subjects with untreated hyperthyroidism.&#xD;
&#xD;
          -  Have pruritus of psychiatric etiology (eg, delusions of parasitosis, obsessive&#xD;
             compulsive disorder, or major depression) or neuropathic etiology (eg, due to&#xD;
             shingles, spinal cord injury or with neurologic deficit).&#xD;
&#xD;
          -  Have pruritus due to urticaria, drug allergy, or infection (such as pityriasis rosea&#xD;
             or tinea or active human immunodeficiency virus [HIV]). Note: Subjects with HIV who&#xD;
             have undetectable viral load, CD 4 counts &gt;200 cells/cc, and stable retroviral therapy&#xD;
             may enroll.&#xD;
&#xD;
          -  Are on medications known to cause pruritus (ie, Erbitux®, opioids, cocaine,&#xD;
             amphetamines, and angiotensin converting enzyme [ACE] inhibitors) and are suspected of&#xD;
             having drug-induced pruritus.&#xD;
&#xD;
          -  Have taken investigational medications within 30 days prior to Screening.&#xD;
&#xD;
          -  Are currently participating in any other clinical study.&#xD;
&#xD;
          -  Have a history (within the previous 4 weeks) of use of tricyclic antidepressants,&#xD;
             selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake&#xD;
             inhibitors (SNRIS), monoamine oxidase (MAO) inhibitors, opioids, immunemodulators&#xD;
             (e.g. azathioprine, methotrexate, mycophenolate mofetil, cyclosporine A, antibodies),&#xD;
             or neuroactive medications (e.g. pregabalin, gabapentin).&#xD;
&#xD;
          -  Have a history (within the previous 4 weeks) of use of sedatives or tranquilizers.&#xD;
&#xD;
        Subjects must undergo an appropriate washout period from any sedatives or tranquilizers&#xD;
        before enrolling in the study.&#xD;
&#xD;
          -  Are currently treated with strong CYP3A4 inhibitors (e.g. conazole, ketoconazole,&#xD;
             fluconazole, itraconazole, voroconazole etc. or erythromycin). The co-administration&#xD;
             of moderate CYP3A4 inhibitors to VPD-737 may be allowed with investigator agreement&#xD;
             and appropriate safety monitoring.&#xD;
&#xD;
          -  Received ultraviolet B (UVB) or psoralen + ultraviolet A (PUVA) treatment within 30&#xD;
             days prior to Screening.&#xD;
&#xD;
          -  Within the past 12 months, have expressed suicidal ideation with some intent to act.&#xD;
&#xD;
          -  Started or changed creams, or emollients including over-the-counter (OTC) preparations&#xD;
             or bath oil treatment for relief of pruritus within 2 weeks prior to Screening.&#xD;
&#xD;
          -  Have any social or medical condition (eg, alcoholism, drug dependency, psychotic&#xD;
             state) that, in the investigator's opinion, might interfere with the subject's ability&#xD;
             to comply with the requirements of the protocol.&#xD;
&#xD;
          -  Are employees of the study site or of the Sponsor's company.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonja Staender, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Muenster, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Study Site 07</name>
      <address>
        <city>Berlin-Mitte</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 08</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 06</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 12</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 02</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 09</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 05</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 03</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 11</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 04</name>
      <address>
        <city>Lubeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 14</name>
      <address>
        <city>Mainz</city>
        <zip>55101</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 01</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 16</name>
      <address>
        <city>München</city>
        <zip>80337</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 15</name>
      <address>
        <city>Selters</city>
        <zip>56242</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 10</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>December 10, 2020</results_first_submitted>
  <results_first_submitted_qc>January 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 2, 2021</results_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prurigo Nodularis</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Lichen-simplex chronicus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prurigo</mesh_term>
    <mesh_term>Neurodermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Serlopitant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The participants were randomized at 15 sites in Germany.</recruitment_details>
      <pre_assignment_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.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Randomized participants 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.</description>
        </group>
        <group group_id="P2">
          <title>Serlopitant</title>
          <description>Randomized participants 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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event or Serious Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Occurrence of an Exclusion Criterion</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Of the 128 randomized participants, 127 received study drug (63 placebo, 64 serlopitant) and comprised the ITT population.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Randomized participants 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.</description>
        </group>
        <group group_id="B2">
          <title>Serlopitant</title>
          <description>Randomized participants 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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.1" spread="11.14"/>
                    <measurement group_id="B2" value="57.1" spread="12.00"/>
                    <measurement group_id="B3" value="57.6" spread="11.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Visual Analog Scale at Baseline</title>
        <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline</time_frame>
        <population>The Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Visual Analog Scale at Baseline</title>
          <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
          <population>The Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.92" spread="1.630"/>
                    <measurement group_id="O2" value="7.88" spread="1.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Visual Analog Scale at Week 2</title>
        <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
        <time_frame>At Week 2</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Visual Analog Scale at Week 2</title>
          <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.01" spread="2.187"/>
                    <measurement group_id="O2" value="6.06" spread="2.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0111</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Visual Analog Scale at Week 4</title>
        <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
        <time_frame>At Week 4</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Visual Analog Scale at Week 4</title>
          <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.32" spread="2.403"/>
                    <measurement group_id="O2" value="5.41" spread="2.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0248</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Visual Analog Scale at Week 8</title>
        <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
        <time_frame>At Week 8</time_frame>
        <population>Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Visual Analog Scale at Week 8</title>
          <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
          <population>Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="2.630"/>
                    <measurement group_id="O2" value="4.21" spread="2.746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus</title>
        <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline and Week 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus</title>
          <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Not Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning</title>
        <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline and Week 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning</title>
          <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Not Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Not Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging</title>
        <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline and Week 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging</title>
          <description>At study visits, participants 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). Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Not Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Not Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Mild Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Moderately Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Very Severely Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Worst Visual Analog Scale (VAS)</title>
        <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Worst Visual Analog Scale (VAS)</title>
          <description>At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of &quot;no itch&quot; (0 cm) and worst imaginable itch&quot; (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.75" spread="1.316"/>
                    <measurement group_id="O2" value="8.43" spread="1.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.92" spread="1.733"/>
                    <measurement group_id="O2" value="6.85" spread="2.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.46" spread="2.285"/>
                    <measurement group_id="O2" value="6.19" spread="2.690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" spread="2.591"/>
                    <measurement group_id="O2" value="4.82" spread="2.729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)</title>
        <description>The PGA included a question: Did the pruritus improve during the treatment period (yes/no).</description>
        <time_frame>At Weeks 2, 4, and 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)</title>
          <description>The PGA included a question: Did the pruritus improve during the treatment period (yes/no).</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Rating Scale (NRS)</title>
        <description>Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.</description>
        <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Rating Scale (NRS)</title>
          <description>Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.65" spread="1.669"/>
                    <measurement group_id="O2" value="7.60" spread="1.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.23" spread="2.043"/>
                    <measurement group_id="O2" value="5.50" spread="1.944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" spread="2.133"/>
                    <measurement group_id="O2" value="4.91" spread="2.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.11" spread="2.320"/>
                    <measurement group_id="O2" value="4.02" spread="2.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0175</p_value>
            <p_value_desc>p-value assume equal variance</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dermatology Life Quality Index (DLQI)</title>
        <description>At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.&#xD;
The scoring of each question is as follows:&#xD;
Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.&#xD;
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.&#xD;
Interpreting the DLQI Scores:&#xD;
0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.</description>
        <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Dermatology Life Quality Index (DLQI)</title>
          <description>At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.&#xD;
The scoring of each question is as follows:&#xD;
Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.&#xD;
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.&#xD;
Interpreting the DLQI Scores:&#xD;
0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="7.03"/>
                    <measurement group_id="O2" value="13.7" spread="6.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="6.94"/>
                    <measurement group_id="O2" value="11.6" spread="6.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="6.56"/>
                    <measurement group_id="O2" value="11.4" spread="6.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="6.83"/>
                    <measurement group_id="O2" value="10.6" spread="7.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pruritus-specific Quality of Life (ItchyQoL)</title>
        <description>At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.&#xD;
Items should be scored for the following answers:&#xD;
Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.</description>
        <time_frame>At Baseline, Weeks 2, 4, and 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Pruritus-specific Quality of Life (ItchyQoL)</title>
          <description>At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.&#xD;
Items should be scored for the following answers:&#xD;
Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.68" spread="0.737"/>
                    <measurement group_id="O2" value="3.52" spread="0.679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="0.795"/>
                    <measurement group_id="O2" value="3.36" spread="0.670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.863"/>
                    <measurement group_id="O2" value="3.26" spread="0.730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.876"/>
                    <measurement group_id="O2" value="3.09" spread="0.904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Benefit Index, Version for Patients With Pruritus (PBI-P)</title>
        <description>At Visits 2 and 5 (or Early termination) only, participants 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 participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants 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. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;does/did not apply to me&quot; = 5; and missing value = -9. Higher scores indicated better outcome.</description>
        <time_frame>At Week 8 / End of Treatment</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Benefit Index, Version for Patients With Pruritus (PBI-P)</title>
          <description>At Visits 2 and 5 (or Early termination) only, participants 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 participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants 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. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for &quot;does/did not apply to me&quot; = 5; and missing value = -9. Higher scores indicated better outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.984"/>
                    <measurement group_id="O2" value="1.16" spread="1.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0625</p_value>
            <p_value_desc>p-value assume equal variance.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)</title>
        <description>Using the IGA, physicians rated change in PN lesions (if any) from +5 (&quot;markedly improved&quot;) to -5 (&quot;markedly worse&quot;). Higher scores indicated better outcome.</description>
        <time_frame>At Week 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)</title>
          <description>Using the IGA, physicians rated change in PN lesions (if any) from +5 (&quot;markedly improved&quot;) to -5 (&quot;markedly worse&quot;). Higher scores indicated better outcome.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Markedly Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Largely Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately To Largely Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mildly Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mildly Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately To Largely Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Largely Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement on Prurigo Activity Score (PAS)</title>
        <description>Using the PAS, physicians described, localized, counted, and measured PN lesions.&#xD;
One of the 7 items was:&#xD;
Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = &gt; 75%)&#xD;
a. Prurigo lesions with excoriations/crusts&#xD;
Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.</description>
        <time_frame>At Day 1 and Week 8</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each day and week.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement on Prurigo Activity Score (PAS)</title>
          <description>Using the PAS, physicians described, localized, counted, and measured PN lesions.&#xD;
One of the 7 items was:&#xD;
Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = &gt; 75%)&#xD;
a. Prurigo lesions with excoriations/crusts&#xD;
Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.&#xD;
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each day and week.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, 1 - 25 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 26 - 50 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 51 - 75 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, &gt;75 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, 0 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, 1 - 25 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, 26 - 50 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, 51 - 75 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, &gt;75 %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Rescue Medication Usage</title>
        <description>Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.</description>
        <time_frame>Pre-treatment, upto 8 Weeks</time_frame>
        <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Rescue Medication Usage</title>
          <description>Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.</description>
          <population>The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment Rescue Medication Used</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used Rescue Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <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.</description>
        <time_frame>From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)</time_frame>
        <population>Safety population - participants who received at least one dose of study drug. This population was analyzed based upon the actual treatment received. Participants with dosing errors were assigned to a treatment group based upon the treatment they received most often.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized participants 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.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant</title>
            <description>Randomized participants 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <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.</description>
          <population>Safety population - participants who received at least one dose of study drug. This population was analyzed based upon the actual treatment received. Participants with dosing errors were assigned to a treatment group based upon the treatment they received most often.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Treatment-emergent adverse events (TEAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with TEAEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with TEAEs related to study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with TEAEs by maximum severity, Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with TEAEs by maximum severity, Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with TEAEs by maximum severity, Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Randomized participants 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.</description>
        </group>
        <group group_id="E2">
          <title>Serlopitant</title>
          <description>Randomized participants 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.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 17</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic elastosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 17</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Iain Stuart, PhD.</name_or_title>
      <organization>Menlo Therapeutics Inc. (formerly Tigercat Pharma, Inc.)</organization>
      <phone>1- 800-775-7936</phone>
      <email>Iain.Stuart@foamix.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02196324
org study id: TCP-102
nct id: NCT02196324
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor
      antagonist is safe and effective for treatment of prurigo nodularis versus placebo.
The sensation of itch is transmitted to the brain through the nervous system. Several
      chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat
      this condition by blocking one of the chemicals involved in the transmission of the itch
      signal. This is an oral drug administered once daily It has been used in other trials and has
      shown to be safe at the doses used in this trial. The trial will involve once daily pills for
      8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper
      during the study period. Patients will also be monitored for safety and will have blood taken
      for testing and several points during the trial. Overall participation will last about 14
      weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average Visual Analog Scale at Baseline
time frame: At Baseline
description: At study visits, participants 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 Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
measure: Average Visual Analog Scale at Week 2
time frame: At Week 2
description: At study visits, participants 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. Higher scores indicated worse outcome.
measure: Average Visual Analog Scale at Week 4
time frame: At Week 4
description: At study visits, participants 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. Higher scores indicated worse outcome.
measure: Average Visual Analog Scale at Week 8
time frame: At Week 8
description: At study visits, participants 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. Higher scores indicated worse outcome.
measure: Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
time frame: At Baseline and Week 8
description: At study visits, participants 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). Higher scores indicated worse outcome.
measure: Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
time frame: At Baseline and Week 8
description: At study visits, participants 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). Higher scores indicated worse outcome.
measure: Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
time frame: At Baseline and Week 8
description: At study visits, participants 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). Higher scores indicated worse outcome.
measure: Worst Visual Analog Scale (VAS)
time frame: At Baseline, Weeks 2, 4, and 8
description: At study visits, participants 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. Higher scores indicated worse outcome.
measure: Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
time frame: At Weeks 2, 4, and 8
description: The PGA included a question: Did the pruritus improve during the treatment period (yes/no).
measure: Numeric Rating Scale (NRS)
time frame: At Baseline, Weeks 2, 4, and 8
description: Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.
measure: Dermatology Life Quality Index (DLQI)
time frame: At Baseline, Weeks 2, 4, and 8
description: At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.
The scoring of each question is as follows:
Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Interpreting the DLQI Scores:
0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.
measure: Pruritus-specific Quality of Life (ItchyQoL)
time frame: At Baseline, Weeks 2, 4, and 8
description: At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.
Items should be scored for the following answers:
Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.
measure: Patient Benefit Index, Version for Patients With Pruritus (PBI-P)
time frame: At Week 8 / End of Treatment
description: At Visits 2 and 5 (or Early termination) only, participants 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 participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants 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. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "does/did not apply to me" = 5; and missing value = -9. Higher scores indicated better outcome.
measure: Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
time frame: At Week 8
description: Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.
measure: Number of Participants With Improvement on Prurigo Activity Score (PAS)
time frame: At Day 1 and Week 8
description: Using the PAS, physicians described, localized, counted, and measured PN lesions.
One of the 7 items was:
Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = > 75%)
a. Prurigo lesions with excoriations/crusts
Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
measure: Participants With Rescue Medication Usage
time frame: Pre-treatment, upto 8 Weeks
description: Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
measure: Number of Participants With Adverse Events (AEs)
time frame: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
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.
arm group label: serlopitant 5 mg tablets
arm group type: Active Comparator
description: serlopitant 5 mg tablets
arm group label: Placebo tablets
arm group type: Placebo Comparator
description: Placebo tablets
intervention type: Drug
intervention name: serlopitant
description: NK1 receptor antagonist
arm group label: serlopitant 5 mg tablets
other name: VPD-737
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sonja Staender, MD
role: Principal Investigator
affiliation: University of Muenster, Germany
facility: 
facility: 
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facility: 
country: Germany
responsible party type: Sponsor
mesh term: Prurigo
mesh term: Neurodermatitis
mesh term: Serlopitant
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 