<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/NCT03253094</url>
  </required_header>
  <id_info>
    <org_study_id>SCY-078-204</org_study_id>
    <nct_id>NCT03253094</nct_id>
  </id_info>
  <brief_title>Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis</brief_title>
  <acronym>DOVE</acronym>
  <official_title>A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scynexis, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scynexis, 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>
      This is a multicenter, randomized, double-blind, double-dummy, active-controlled,&#xD;
      dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus&#xD;
      oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute&#xD;
      Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per&#xD;
      treatment group) will be enrolled and randomized into the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled,&#xD;
      dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis.&#xD;
      Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose&#xD;
      regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole)&#xD;
      for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site&#xD;
      visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 4, 2018</completion_date>
  <primary_completion_date type="Actual">May 4, 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>
    <intervention_model_description>randomized, double-blind, double-dummy, active-controlled, dose-finding</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Cure (Complete Resolution of Signs and Symptoms)</measure>
    <time_frame>8-12 days</time_frame>
    <description>Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Co-occurrence of Clinical and Mycological Cure</measure>
    <time_frame>29 days</time_frame>
    <description>The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events</measure>
    <time_frame>up to 29 days</time_frame>
    <description>The number of subjects with treatment related adverse events</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Candida Vulvovaginitis</condition>
  <arm_group>
    <arm_group_label>Fluconazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150 mg/day for 1 day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibrexafungerp 750mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>750mg QD for 1 day only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibrexafungerp 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300mg BID for 1 day only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibrexafungerp 450mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>450mg BID for 1 day only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibrexafungerp 150mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150mg BID for 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibrexafungerp 300mg D1-D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300mg BID for 3 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <description>Oral Antifungal comparator</description>
    <arm_group_label>Fluconazole</arm_group_label>
    <other_name>Diflucan, Azole antifungal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCY-078</intervention_name>
    <description>Investigational Antifungal</description>
    <arm_group_label>Ibrexafungerp 150mg</arm_group_label>
    <arm_group_label>Ibrexafungerp 300mg</arm_group_label>
    <arm_group_label>Ibrexafungerp 300mg D1-D3</arm_group_label>
    <arm_group_label>Ibrexafungerp 450mg</arm_group_label>
    <arm_group_label>Ibrexafungerp 750mg</arm_group_label>
    <other_name>Ibrexafungerp</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a female of at least 18 years of age&#xD;
&#xD;
          2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive&#xD;
             microscopic examination with 10% KOH in a vaginal sample revealing yeast forms&#xD;
             (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any vaginal condition other than AVVC that may interfere with the&#xD;
             diagnosis or evaluation of response to therapy, such as suspected or confirmed&#xD;
             concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)&#xD;
&#xD;
          2. Need for systemic and/or topical (vaginal) antifungal treatment, including&#xD;
             prescription or over-the-counter products during the study and treatment for VVC 28&#xD;
             days prior to randomization&#xD;
&#xD;
          3. Subject is actively menstruating at the time of the Baseline visit.&#xD;
&#xD;
          4. Subject has uncontrolled diabetes mellitus.&#xD;
&#xD;
          5. Subject has a vaginal sample with pH &gt;4.5.&#xD;
&#xD;
          6. Subject has a history of or an active cervical/vaginal cancer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Angulo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Scynexis, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Personal Health Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Trials AZ, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Care Research Corp.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Research Group, LLC</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altus Research, Inc.</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OB-GYN Associates of Mid-Florida P.A.</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Age Medical Research Corp.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visionary Investigators Network</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta North Gynecology, P.C.</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cypress Medical Research Center, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women Under Study, LLC</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolan Park Medical Building</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants in Women's Healthcare, Inc.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence OB/GYN Clinical Research, LLC</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Research Center</name>
      <address>
        <city>Plainsboro</city>
        <state>New Jersey</state>
        <zip>08536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research - Central Carolina</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research South, LLC</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-Medical Research Center of Memphis, LLC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tmc Life Research, Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Women's Health, Research, Gynecology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>June 30, 2021</results_first_submitted>
  <results_first_submitted_qc>August 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2021</results_first_posted>
  <disposition_first_submitted>October 20, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 11, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 12, 2021</disposition_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 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>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Vulvovaginitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Ibrexafungerp</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <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>July 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03253094/Prot_001.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>June 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03253094/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ibrexafungerp 750-mg</title>
          <description>750 mg QD for 1 day only</description>
        </group>
        <group group_id="P2">
          <title>Ibrexafungerp 300-mg</title>
          <description>300 mg BID for 1 day only</description>
        </group>
        <group group_id="P3">
          <title>Ibrexafungerp 450-mg</title>
          <description>450 mg BID for 1 day only</description>
        </group>
        <group group_id="P4">
          <title>Ibrexafungerp 150-mg</title>
          <description>150 mg BID for 3 days</description>
        </group>
        <group group_id="P5">
          <title>Ibrexafungerp 300-mg (3 Days)</title>
          <description>300 mg BID for 3 days</description>
        </group>
        <group group_id="P6">
          <title>Fluconazole</title>
          <description>150 mg QD for 1 day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="32"/>
                <participants group_id="P5" count="32"/>
                <participants group_id="P6" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Discontinued</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="27"/>
                <participants group_id="P6" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ibrexafungerp 750-mg</title>
          <description>750 mg QD for 1 day only</description>
        </group>
        <group group_id="B2">
          <title>Ibrexafungerp 300-mg</title>
          <description>300 mg BID for 1 day only</description>
        </group>
        <group group_id="B3">
          <title>Ibrexafungerp 450-mg</title>
          <description>450 mg BID for 1 day only</description>
        </group>
        <group group_id="B4">
          <title>Ibrexafungerp 150-mg</title>
          <description>150 mg BID for 3 days</description>
        </group>
        <group group_id="B5">
          <title>Ibrexafungerp 300-mg (3 Days)</title>
          <description>300 mg BID for 3 days</description>
        </group>
        <group group_id="B6">
          <title>Fluconazole</title>
          <description>150 mg QD for 1 day</description>
        </group>
        <group group_id="B7">
          <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="32"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="32"/>
            <count group_id="B5" value="32"/>
            <count group_id="B6" value="32"/>
            <count group_id="B7" value="186"/>
          </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="34.6" spread="12.3"/>
                    <measurement group_id="B2" value="34.4" spread="11.3"/>
                    <measurement group_id="B3" value="34.5" spread="9.8"/>
                    <measurement group_id="B4" value="33.3" spread="10.5"/>
                    <measurement group_id="B5" value="32.0" spread="8.5"/>
                    <measurement group_id="B6" value="33.8" spread="10.1"/>
                    <measurement group_id="B7" value="33.7" spread="10.4"/>
                  </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="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="32"/>
                    <measurement group_id="B7" value="186"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="21"/>
                    <measurement group_id="B7" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="32"/>
                    <measurement group_id="B7" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Cure (Complete Resolution of Signs and Symptoms)</title>
        <description>Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit</description>
        <time_frame>8-12 days</time_frame>
        <population>mITT</population>
        <group_list>
          <group group_id="O1">
            <title>Ibrexafungerp 750-mg</title>
            <description>750 mg QD D1 only</description>
          </group>
          <group group_id="O2">
            <title>Ibrexafungerp 300-mg</title>
            <description>300 mg BID D1 only</description>
          </group>
          <group group_id="O3">
            <title>Ibrexafungerp 450-mg</title>
            <description>450 mg BID D1 only</description>
          </group>
          <group group_id="O4">
            <title>Ibrexafungerp 150-mg</title>
            <description>150 mg BID D1 to D3</description>
          </group>
          <group group_id="O5">
            <title>Ibrexafungerp 300-mg D1 to D3</title>
            <description>300 mg BID D1 to D3</description>
          </group>
          <group group_id="O6">
            <title>Fluconazole</title>
            <description>150 mg QD D1 only</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Cure (Complete Resolution of Signs and Symptoms)</title>
          <description>Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit</description>
          <population>mITT</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="26"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Clinical cure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinical failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Co-occurrence of Clinical and Mycological Cure</title>
        <description>The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.</description>
        <time_frame>29 days</time_frame>
        <population>mITT</population>
        <group_list>
          <group group_id="O1">
            <title>Ibrexafungerp 750-mg</title>
            <description>750 mg QD D1 only</description>
          </group>
          <group group_id="O2">
            <title>Ibrexafungerp 300-mg</title>
            <description>300 mg BID D1 only</description>
          </group>
          <group group_id="O3">
            <title>Ibrexafungerp 450-mg</title>
            <description>450 mg BID D1 only</description>
          </group>
          <group group_id="O4">
            <title>Ibrexafungerp 150-mg</title>
            <description>150 mg BID D1 to D3</description>
          </group>
          <group group_id="O5">
            <title>Ibrexafungerp 300-mg D1 to D3</title>
            <description>300 mg BID D1 to D3</description>
          </group>
          <group group_id="O6">
            <title>Fluconazole</title>
            <description>150 mg QD D1 only</description>
          </group>
        </group_list>
        <measure>
          <title>Co-occurrence of Clinical and Mycological Cure</title>
          <description>The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.</description>
          <population>mITT</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="26"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Clinical cure and Mycological Eradication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinical failure and/or mycological persistence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Treatment Emergent Adverse Events</title>
        <description>The number of subjects with treatment related adverse events</description>
        <time_frame>up to 29 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ibrexafungerp 750-mg</title>
            <description>750 mg QD D1 only</description>
          </group>
          <group group_id="O2">
            <title>Ibrexafungerp 300-mg</title>
            <description>300 mg BID D1 only</description>
          </group>
          <group group_id="O3">
            <title>Ibrexafungerp 450-mg</title>
            <description>450 mg BID D1 only</description>
          </group>
          <group group_id="O4">
            <title>Ibrexafungerp 150-mg</title>
            <description>150 mg BID D1 to D3</description>
          </group>
          <group group_id="O5">
            <title>Ibrexafungerp 300-mg D1 to D3</title>
            <description>300 mg BID D1 to D3</description>
          </group>
          <group group_id="O6">
            <title>Fluconazole</title>
            <description>150 mg QD D1 only</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events</title>
          <description>The number of subjects with treatment related adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="32"/>
                <count group_id="O6" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Treatment related Treatment-emergent adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Treatment related Treatment-emergent adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>29 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ibrexafungerp 750-mg</title>
          <description>750 mg QD D1 only</description>
        </group>
        <group group_id="E2">
          <title>Ibrexafungerp 300-mg</title>
          <description>300 mg BID D1 only</description>
        </group>
        <group group_id="E3">
          <title>Ibrexafungerp 450-mg</title>
          <description>450 mg BID D1 only</description>
        </group>
        <group group_id="E4">
          <title>Ibrexafungerp 150-mg</title>
          <description>150 mg BID D1 to D3</description>
        </group>
        <group group_id="E5">
          <title>Ibrexafungerp 300-mg D1 to D3</title>
          <description>300 mg BID D1 to D3</description>
        </group>
        <group group_id="E6">
          <title>Fluconazole</title>
          <description>150 mg QD D1 only</description>
        </group>
      </group_list>
      <serious_events>
        <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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="21" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="32"/>
              </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 NOT 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>Dr. David Angulo</name_or_title>
      <organization>SCYNEXIS</organization>
      <phone>(201) 884 - 5471</phone>
      <email>david.angulo@scynexis.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/NCT03253094
org study id: SCY-078-204
nct id: NCT03253094
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, randomized, double-blind, double-dummy, active-controlled,
      dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus
      oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute
      Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per
      treatment group) will be enrolled and randomized into the study.
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled,
      dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis.
      Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose
      regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole)
      for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site
      visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, double-blind, double-dummy, active-controlled, dose-finding
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical Cure (Complete Resolution of Signs and Symptoms)
time frame: 8-12 days
description: Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
measure: Co-occurrence of Clinical and Mycological Cure
time frame: 29 days
description: The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
measure: Incidence of Treatment Emergent Adverse Events
time frame: up to 29 days
description: The number of subjects with treatment related adverse events
arm group label: Fluconazole
arm group type: Active Comparator
description: 150 mg/day for 1 day
arm group label: Ibrexafungerp 750mg
arm group type: Experimental
description: 750mg QD for 1 day only
arm group label: Ibrexafungerp 300mg
arm group type: Experimental
description: 300mg BID for 1 day only
arm group label: Ibrexafungerp 450mg
arm group type: Experimental
description: 450mg BID for 1 day only
arm group label: Ibrexafungerp 150mg
arm group type: Experimental
description: 150mg BID for 3 days
arm group label: Ibrexafungerp 300mg D1-D3
arm group type: Experimental
description: 300mg BID for 3 days
intervention type: Drug
intervention name: Fluconazole
description: Oral Antifungal comparator
arm group label: Fluconazole
other name: Diflucan, Azole antifungal
intervention type: Drug
intervention name: SCY-078
description: Investigational Antifungal
arm group label: Ibrexafungerp 150mg
arm group label: Ibrexafungerp 300mg
arm group label: Ibrexafungerp 300mg D1-D3
arm group label: Ibrexafungerp 450mg
arm group label: Ibrexafungerp 750mg
other name: Ibrexafungerp
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Angulo, MD
role: Study Director
affiliation: Scynexis, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal
mesh term: Vulvovaginitis
mesh term: Fluconazole
mesh term: Ibrexafungerp
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 