<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/NCT02975206</url>
  </required_header>
  <id_info>
    <org_study_id>MTI-103</org_study_id>
    <nct_id>NCT02975206</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis</brief_title>
  <acronym>ATOMIK</acronym>
  <official_title>A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis</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>Yes</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>
      Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic&#xD;
      Dermatitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will&#xD;
      be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or&#xD;
      placebo for 6 weeks. During the screening period, subjects will be provided with an&#xD;
      electronic device for recording electronic diary (eDiary) assessments throughout the study.&#xD;
      This eDiary will be used to capture efficacy endpoint data and treatment information. At the&#xD;
      Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with&#xD;
      a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2,&#xD;
      subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The&#xD;
      primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week&#xD;
      treatment period, all subjects will enter a 4-week follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">January 16, 2018</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>Change in WI-NRS From Baseline to Week 6</measure>
    <time_frame>Week 6 compared to Baseline</time_frame>
    <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WI-NRS 4-point Responder Rate at Week 6</measure>
    <time_frame>Week 6 compared to Baseline</time_frame>
    <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (ItchyQoL) From Baseline to Week 6</measure>
    <time_frame>Week 6 compared to Baseline</time_frame>
    <description>ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">484</enrollment>
  <condition>Pruritus</condition>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Serlopitant High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>serlopitant tablets - high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serlopitant Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>serlopitant tablets - low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>matching placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Serlopitant High Dose</intervention_name>
    <description>serlopitant tablets - high dose</description>
    <arm_group_label>Serlopitant High Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>placebo tablet</description>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Serlopitant Low Dose</intervention_name>
    <description>serlopitant tablets - low dose</description>
    <arm_group_label>Serlopitant Low Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 13 years or older&#xD;
&#xD;
          -  Pruritus prior to and during the initial screening period&#xD;
&#xD;
          -  Diagnosis of atopic dermatitis&#xD;
&#xD;
          -  Judged to be in good health in the investigator's opinion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with study drug or similar drug&#xD;
&#xD;
          -  Pruritus due to another reason besides atopic dermatitis&#xD;
&#xD;
          -  Presence of any medical condition or disability that could interfere with study&#xD;
&#xD;
          -  History of hypersensitivity to serlopitant or any of its components&#xD;
&#xD;
          -  Currently pregnant or male partner of pregnant female&#xD;
&#xD;
          -  Females of childbearing potential who are unable or unwilling to use adequate&#xD;
             contraception or who are breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Spellman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vyne Therapeutics Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Study Site 332</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 363</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 340</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 364</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 334</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 386</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 366</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 338</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 383</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 374</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 347</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 356</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 333</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 376</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 358</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 370</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 331</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 348</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 378</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 353</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 368</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 377</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 369</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 349</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 381</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 360</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 380</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 344</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 379</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 350</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 371</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 387</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 352</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 375</name>
      <address>
        <city>Forest Hills</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 373</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 341</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 355</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 337</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 345</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 362</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 382</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 343</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 357</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 365</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 335</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 359</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 339</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 361</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 351</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 342</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 336</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 367</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>January 14, 2019</results_first_submitted>
  <results_first_submitted_qc>February 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 5, 2019</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
    <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>November 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02975206/Prot_000.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>February 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02975206/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="P2">
          <title>Serlopitant 1 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="P3">
          <title>Placebo Oral Tablet</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="161"/>
                <participants group_id="P3" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="144"/>
                <participants group_id="P3" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (e.g., lost to follow up)</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>Serlopitant 1 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="B3">
          <title>Placebo Oral Tablet</title>
          <description>Subjects received a 3-tablet Placebo oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="B4">
          <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="161"/>
            <count group_id="B2" value="161"/>
            <count group_id="B3" value="162"/>
            <count group_id="B4" value="484"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="161"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="162"/>
                    <count group_id="B4" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="418"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="161"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="162"/>
                    <count group_id="B4" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.9" spread="16.62"/>
                    <measurement group_id="B2" value="38.1" spread="15.16"/>
                    <measurement group_id="B3" value="37.5" spread="13.04"/>
                    <measurement group_id="B4" value="37.1" spread="15.01"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="161"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="162"/>
                    <count group_id="B4" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="108"/>
                    <measurement group_id="B4" value="325"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="159"/>
                  </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>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="161"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="162"/>
                    <count group_id="B4" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="161"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="162"/>
                    <count group_id="B4" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WI-NRS</title>
          <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Subject-reported score from reflection on past 24 hours. The baseline was established by averaging 7 daily scores leading up to randomization.</description>
          <population>The row populations here represent the Full Analysis Set, not all subjects randomized.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                    <count group_id="B2" value="161"/>
                    <count group_id="B3" value="158"/>
                    <count group_id="B4" value="479"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.38" spread="0.993"/>
                    <measurement group_id="B2" value="8.23" spread="1.039"/>
                    <measurement group_id="B3" value="8.26" spread="1.057"/>
                    <measurement group_id="B4" value="8.29" spread="1.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in WI-NRS From Baseline to Week 6</title>
        <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.</description>
        <time_frame>Week 6 compared to Baseline</time_frame>
        <population>These figures represent full analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 1 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O3">
            <title>Placebo Oral Tablet</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in WI-NRS From Baseline to Week 6</title>
          <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.</description>
          <population>These figures represent full analysis set.</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="160"/>
                <count group_id="O2" value="161"/>
                <count group_id="O3" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.25" spread="2.198"/>
                    <measurement group_id="O2" value="-2.32" spread="2.418"/>
                    <measurement group_id="O3" value="-2.01" spread="2.212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WI-NRS 4-point Responder Rate at Week 6</title>
        <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.</description>
        <time_frame>Week 6 compared to Baseline</time_frame>
        <population>These figures represent full analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 1 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O3">
            <title>Placebo Oral Tablet</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>WI-NRS 4-point Responder Rate at Week 6</title>
          <description>Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.</description>
          <population>These figures represent full analysis set.</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="160"/>
                <count group_id="O2" value="161"/>
                <count group_id="O3" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life (ItchyQoL) From Baseline to Week 6</title>
        <description>ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.</description>
        <time_frame>Week 6 compared to Baseline</time_frame>
        <population>These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Serlopitant 5 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Serlopitant 1 mg</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
          </group>
          <group group_id="O3">
            <title>Placebo Oral Tablet</title>
            <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life (ItchyQoL) From Baseline to Week 6</title>
          <description>ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.</description>
          <population>These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.</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="130"/>
                <count group_id="O2" value="142"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="0.749"/>
                    <measurement group_id="O2" value="-0.58" spread="0.779"/>
                    <measurement group_id="O3" value="-0.53" spread="0.683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time.</time_frame>
      <desc>The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Serlopitant 5 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>Serlopitant 1 mg</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks</description>
        </group>
        <group group_id="E3">
          <title>Placebo Oral Tablet</title>
          <description>Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Eye injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>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="27" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="160"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="158"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anna Gururajan</name_or_title>
      <organization>Menlo Therapeutics Inc.</organization>
      <phone>(650) 486-1416</phone>
      <email>agururajan@menlotx.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/NCT02975206
org study id: MTI-103
nct id: NCT02975206
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic
      Dermatitis
This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will
      be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or
      placebo for 6 weeks. During the screening period, subjects will be provided with an
      electronic device for recording electronic diary (eDiary) assessments throughout the study.
      This eDiary will be used to capture efficacy endpoint data and treatment information. At the
      Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with
      a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2,
      subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The
      primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week
      treatment period, all subjects will enter a 4-week follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in WI-NRS From Baseline to Week 6
time frame: Week 6 compared to Baseline
description: Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
measure: WI-NRS 4-point Responder Rate at Week 6
time frame: Week 6 compared to Baseline
description: Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.
measure: Change in Quality of Life (ItchyQoL) From Baseline to Week 6
time frame: Week 6 compared to Baseline
description: ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.
arm group label: Serlopitant High Dose
arm group type: Experimental
description: serlopitant tablets - high dose
arm group label: Serlopitant Low Dose
arm group type: Experimental
description: serlopitant tablets - low dose
arm group label: Placebo Oral Tablet
arm group type: Placebo Comparator
description: matching placebo tablets
intervention type: Drug
intervention name: Serlopitant High Dose
description: serlopitant tablets - high dose
arm group label: Serlopitant High Dose
intervention type: Drug
intervention name: Placebo Oral Tablet
description: placebo tablet
arm group label: Placebo Oral Tablet
intervention type: Drug
intervention name: Serlopitant Low Dose
description: serlopitant tablets - low dose
arm group label: Serlopitant Low Dose
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Mary Spellman, MD
role: Study Director
affiliation: Vyne Therapeutics Inc.
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country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Pruritus
mesh term: Serlopitant
provided document: 
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certain agreements: 
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