<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/NCT02975271</url>
  </required_header>
  <id_info>
    <org_study_id>MTI-104</org_study_id>
    <nct_id>NCT02975271</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy, Safety &amp; Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury</brief_title>
  <acronym>AUBURN</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vyne Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vyne Therapeutics Inc.</source>
  <brief_summary>
    <textblock>
      Study of the Efficacy, Safety &amp; Tolerability of Serlopitant for Pruritus (Itch) After Burn&#xD;
      Injury&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business Reasons&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">January 17, 2017</completion_date>
  <primary_completion_date type="Actual">January 17, 2017</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 Itch Intensity - Numeric Rating Scale</measure>
    <time_frame>Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Itch Intensity Responder Rate - Numeric Rating Scale</measure>
    <time_frame>Week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Pruritus</condition>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Serlopitant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose of experimental drug Serlopitant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching dose of Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Serlopitant</intervention_name>
    <arm_group_label>Serlopitant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 18-65 years at consent.&#xD;
&#xD;
          -  History of serious burn injury&#xD;
&#xD;
          -  Pruritus (itchiness) prior to the initial screening visit and during the screening&#xD;
             period&#xD;
&#xD;
          -  Judged to be in good health in the investigator's opinion.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with study drug or similar drug&#xD;
&#xD;
          -  Pruritus (itchiness) due to another reason besides burn injury/ healing.&#xD;
&#xD;
          -  Presence of any medical condition or disability that, in the investigator's opinion,&#xD;
             could interfere with the assessment of safety or efficacy in this trial or compromise&#xD;
             the safety of the subject.&#xD;
&#xD;
          -  History of hypersensitivity to study drug 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>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 404</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 402</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 412</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 403</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 409</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 401</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 413</name>
      <address>
        <city>Seattle</city>
        <state>Washington</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>
  <disposition_first_submitted>August 14, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 20, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 26, 2020</disposition_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>Pruritus</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Serlopitant</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02975271
org study id: MTI-104
nct id: NCT02975271
lead sponsor: 
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn
      Injury
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Itch Intensity - Numeric Rating Scale
time frame: Week 6
measure: Itch Intensity Responder Rate - Numeric Rating Scale
time frame: Week 6
arm group label: Serlopitant
arm group type: Experimental
description: Dose of experimental drug Serlopitant
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching dose of Placebo
intervention type: Drug
intervention name: Serlopitant
arm group label: Serlopitant
intervention type: Drug
intervention name: Placebo
description: Matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pruritus
mesh term: Burns
mesh term: Serlopitant