<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/NCT03841331</url>
  </required_header>
  <id_info>
    <org_study_id>MTI-117</org_study_id>
    <nct_id>NCT03841331</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and&#xD;
      Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</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>Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10</measure>
    <time_frame>At Week 10</time_frame>
    <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8</measure>
    <time_frame>At Weeks 2, 4, 6, and 8</time_frame>
    <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10</measure>
    <time_frame>At Weeks 2, 4, 6, 8, and 10</time_frame>
    <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10</measure>
    <time_frame>At Weeks 2, 4, 6, 8, and 10</time_frame>
    <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Daily WI-NRS Scores Through Week 2</measure>
    <time_frame>Through 2 weeks</time_frame>
    <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10</measure>
    <time_frame>At Weeks 2, 4, 6, and 10</time_frame>
    <description>The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.</time_frame>
    <description>Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Serlopitant and Metabolites</measure>
    <time_frame>At Week 10</time_frame>
    <description>The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">233</enrollment>
  <condition>Pruritus</condition>
  <arm_group>
    <arm_group_label>5 mg Serlopitant Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Serlopitant Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mg 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>5 mg Serlopitant Tablets</intervention_name>
    <description>Serlopitant Tablets</description>
    <arm_group_label>5 mg Serlopitant Tablets</arm_group_label>
    <other_name>VPD-737</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo Tablets</intervention_name>
    <description>Placebo Tablets</description>
    <arm_group_label>5 mg Placebo Tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Male or female, age 18 years or older at consent.&#xD;
&#xD;
          -  The subject must have ongoing chronic pruritus&#xD;
&#xD;
          -  The subject's pruritus is assessed by the investigator to be of unknown origin at&#xD;
             baseline.&#xD;
&#xD;
          -  Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the&#xD;
             Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to&#xD;
             Baseline visit indicating an appropriate pruritus level for the study.&#xD;
&#xD;
          -  The pruritus must have been unresponsive to prior treatment with emollients.&#xD;
&#xD;
          -  The subject's pruritus must be present on multiple segments of the body&#xD;
&#xD;
          -  Willing and able to complete daily eDiary entries within a consistent timeframe for&#xD;
             the duration of the study&#xD;
&#xD;
          -  All females who are of childbearing potential must be willing to practice highly&#xD;
             effective contraception and not be pregnant or nursing&#xD;
&#xD;
          -  Willing to comply with study visits and study related requirements including providing&#xD;
             written informed consent.&#xD;
&#xD;
          -  Adequate cognitive and physical ability, in the investigator's opinion, to comply with&#xD;
             study visits and study related requirements including providing written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Prior treatment with any NK1-receptor antagonists&#xD;
&#xD;
          -  Known dermatologic or systemic condition(s), other than dry skin, that is considered&#xD;
             by the investigator to be the primary cause of current pruritus.&#xD;
&#xD;
          -  Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules,&#xD;
             or history of thyroid malignancy.&#xD;
&#xD;
          -  Use of an excluded therapy within 3 weeks prior to randomization&#xD;
&#xD;
          -  Treatment with any investigational therapy within 3 weeks prior to randomization.&#xD;
&#xD;
          -  Serum creatinine, total bilirubin, alanine aminotransferase or aspartate&#xD;
             aminotransferase &gt; 2.5 times the upper limit of normal during screening.&#xD;
&#xD;
          -  History of malignancy within 3 years prior to randomization, with the (actinic&#xD;
             keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of&#xD;
             skin).&#xD;
&#xD;
          -  Any known major psychiatric diagnosis that would impact the subject's ability to&#xD;
             complete the study&#xD;
&#xD;
          -  Suicidal ideation within 3 years prior to randomization, or any history of suicide&#xD;
             attempt.&#xD;
&#xD;
          -  Known use of recreational drugs.&#xD;
&#xD;
          -  Documented history of parasitic infection, including skin parasites such as scabies,&#xD;
             within 12 weeks prior to randomization.&#xD;
&#xD;
          -  Presence of clinically significant dementia, intellectual impairment, or any medical&#xD;
             condition or disability that, in the investigator's opinion, could interfere with the&#xD;
             assessment of safety or efficacy in this trial or compromise the safety of the&#xD;
             subject.&#xD;
&#xD;
          -  History of hypersensitivity to serlopitant or any of its components.&#xD;
&#xD;
          -  Planned or anticipated major surgical procedure or other activity that would interfere&#xD;
             with the subject's ability to comply with protocol-mandated assessments (e.g. extended&#xD;
             international travel) during the subject's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 221</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 823</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 204</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 803</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 820</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 804</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 811</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 801</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 807</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 331</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 824</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 818</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 349</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 814</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 808</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 822</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 371</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 817</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 821</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 813</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 387</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 816</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 121</name>
      <address>
        <city>Ocean Township</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 802</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 507</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 341</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 810</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 524</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 116</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 522</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 345</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 815</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 805</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 365</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 120</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 819</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 359</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 809</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 217</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 806</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 812</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>09362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>September 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 23, 2020</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>Pruritus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Serlopitant</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03841331/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03841331/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 41 sites in US from 22 January 2019 to 21 January 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.</recruitment_details>
      <pre_assignment_details>During the screening period (3 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) at the Screening visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Serlopitant 5 mg</title>
          <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Serlopitant 5 mg</title>
          <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</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="117"/>
            <count group_id="B2" value="116"/>
            <count group_id="B3" value="233"/>
          </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="12.05"/>
                    <measurement group_id="B2" value="60.7" spread="13.60"/>
                    <measurement group_id="B3" value="59.4" spread="12.89"/>
                  </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="93"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="197"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10</title>
        <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
        <time_frame>At Week 10</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10</title>
          <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="44"/>
                  </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>At Week 10</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5861</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Effect</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.9</ci_lower_limit>
            <ci_upper_limit>11.1</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8</title>
        <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
        <time_frame>At Weeks 2, 4, 6, and 8</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8</title>
          <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responders at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="37"/>
                  </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>At Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5651</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Effect</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.1</ci_lower_limit>
            <ci_upper_limit>8.7</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7769</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Effect</param_type>
            <param_value>-4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.8</ci_lower_limit>
            <ci_upper_limit>6.7</ci_upper_limit>
            <other_analysis_desc>95% Wald confidence intervals for the treatment difference was used.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3285</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Effect</param_type>
            <param_value>2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.1</ci_lower_limit>
            <ci_upper_limit>14.8</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6525</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Effect</param_type>
            <param_value>-2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.4</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10</title>
        <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.</description>
        <time_frame>At Weeks 2, 4, 6, 8, and 10</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10</title>
          <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responders at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 4</title>
              <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>Responders at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responders at Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </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>At Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4952</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment effect</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.6</ci_lower_limit>
            <ci_upper_limit>5.7</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0891</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment effect</param_type>
            <param_value>5.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>12.7</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8447</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment effect</param_type>
            <param_value>-4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.1</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4174</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment effect</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.5</ci_lower_limit>
            <ci_upper_limit>9.4</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 10</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2756</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment effect</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.8</ci_lower_limit>
            <ci_upper_limit>11.2</ci_upper_limit>
            <estimate_desc>95% Wald confidence intervals for the treatment difference was used.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10</title>
        <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
        <time_frame>At Weeks 2, 4, 6, 8, and 10</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10</title>
          <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
          <units>score 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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Observed value)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.37" spread="0.929"/>
                    <measurement group_id="O2" value="8.44" spread="0.855"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="2.115"/>
                    <measurement group_id="O2" value="-1.61" spread="1.961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.41" spread="2.382"/>
                    <measurement group_id="O2" value="-2.46" spread="2.349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.83" spread="2.624"/>
                    <measurement group_id="O2" value="-2.94" spread="2.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Basline at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.99" spread="2.647"/>
                    <measurement group_id="O2" value="-2.97" spread="2.562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.34" spread="2.787"/>
                    <measurement group_id="O2" value="-3.25" spread="2.545"/>
                  </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>At Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4409</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5496</p_value>
            <p_value_desc>At week 4</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6311</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.78</ci_lower_limit>
            <ci_upper_limit>0.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.4738</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 10</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3948</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.60</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Daily WI-NRS Scores Through Week 2</title>
        <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
        <time_frame>Through 2 weeks</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daily WI-NRS Scores Through Week 2</title>
          <description>During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.&#xD;
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
          <units>score 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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (observed value)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.37" spread="0.929"/>
                    <measurement group_id="O2" value="8.44" spread="0.855"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.879"/>
                    <measurement group_id="O2" value="-0.09" spread="0.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="1.836"/>
                    <measurement group_id="O2" value="-0.69" spread="1.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="1.788"/>
                    <measurement group_id="O2" value="-0.77" spread="1.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.16" spread="1.977"/>
                    <measurement group_id="O2" value="-0.96" spread="1.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="2.103"/>
                    <measurement group_id="O2" value="-0.99" spread="1.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="2.174"/>
                    <measurement group_id="O2" value="-1.15" spread="1.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.44" spread="2.331"/>
                    <measurement group_id="O2" value="-1.35" spread="1.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" spread="2.171"/>
                    <measurement group_id="O2" value="-1.35" spread="1.746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.53" spread="2.210"/>
                    <measurement group_id="O2" value="-1.35" spread="1.996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.63" spread="2.460"/>
                    <measurement group_id="O2" value="-1.41" spread="2.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" spread="2.333"/>
                    <measurement group_id="O2" value="-1.69" spread="2.211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.67" spread="2.280"/>
                    <measurement group_id="O2" value="-1.58" spread="2.247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.82" spread="2.335"/>
                    <measurement group_id="O2" value="-1.75" spread="2.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.92" spread="2.518"/>
                    <measurement group_id="O2" value="-1.74" spread="2.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10</title>
        <description>The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.</description>
        <time_frame>At Weeks 2, 4, 6, and 10</time_frame>
        <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10</title>
          <description>The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.</description>
          <population>Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.</population>
          <units>score 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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Observed Value)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.09" spread="10.741"/>
                    <measurement group_id="O2" value="83.53" spread="11.941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.96" spread="27.425"/>
                    <measurement group_id="O2" value="-20.52" spread="28.825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.01" spread="28.906"/>
                    <measurement group_id="O2" value="-28.28" spread="29.731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.83" spread="31.046"/>
                    <measurement group_id="O2" value="-30.92" spread="31.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.64" spread="31.613"/>
                    <measurement group_id="O2" value="-37.42" spread="32.986"/>
                  </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>At Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2440</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.98</ci_lower_limit>
            <ci_upper_limit>9.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6349</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.20</ci_lower_limit>
            <ci_upper_limit>6.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.91</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.3407</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.40</ci_lower_limit>
            <ci_upper_limit>10.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Week 10</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4960</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.52</ci_lower_limit>
            <ci_upper_limit>8.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.</description>
        <time_frame>From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.</time_frame>
        <population>Safety Population - Subset of subjects who received at least one dose of study medication</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.</description>
          <population>Safety Population - Subset of subjects who received at least one dose of study medication</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="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Treatment Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Likely Related to Study Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Serlopitant and Metabolites</title>
        <description>The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.</description>
        <time_frame>At Week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 5 mg</title>
            <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Serlopitant and Metabolites</title>
          <description>The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.</description>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Met-Serl-M1/M1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.02"/>
                    <measurement group_id="O2" value="150.8" spread="120.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Met-Serl-M2/M2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.81"/>
                    <measurement group_id="O2" value="41.6" spread="26.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Met-Serl-M3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.46"/>
                    <measurement group_id="O2" value="60.9" spread="39.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serlopitant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="3.09"/>
                    <measurement group_id="O2" value="634.6" spread="441.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.</time_frame>
      <desc>Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Serlopitant 5 mg</title>
          <description>Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <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="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Intracranial mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="116"/>
              </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</name_or_title>
      <organization>Menlo Therapeutics, 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/NCT03841331
org study id: MTI-117
nct id: NCT03841331
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and
      Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
time frame: At Week 10
description: During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
measure: WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
time frame: At Weeks 2, 4, 6, and 8
description: During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
measure: WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
time frame: At Weeks 2, 4, 6, 8, and 10
description: During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.
measure: Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
time frame: At Weeks 2, 4, 6, 8, and 10
description: During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
measure: Change From Baseline in Daily WI-NRS Scores Through Week 2
time frame: Through 2 weeks
description: During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
measure: Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
time frame: At Weeks 2, 4, 6, and 10
description: The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
description: Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
measure: Plasma Concentrations of Serlopitant and Metabolites
time frame: At Week 10
description: The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.
arm group label: 5 mg Serlopitant Tablets
arm group type: Experimental
description: Serlopitant Tablets
arm group label: 5 mg Placebo Tablets
arm group type: Placebo Comparator
description: Placebo Tablets
intervention type: Drug
intervention name: 5 mg Serlopitant Tablets
description: Serlopitant Tablets
arm group label: 5 mg Serlopitant Tablets
other name: VPD-737
intervention type: Drug
intervention name: Matching Placebo Tablets
description: Placebo Tablets
arm group label: 5 mg Placebo Tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Pruritus
mesh term: Serlopitant
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 