<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/NCT03759340</url>
  </required_header>
  <id_info>
    <org_study_id>ATI-502-AA-203</org_study_id>
    <nct_id>NCT03759340</nct_id>
  </id_info>
  <brief_title>ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)</brief_title>
  <official_title>Open-Label Study of ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aclaris Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aclaris Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label study of ATI-502 Topical Solution for the treatment of AA, AU, and AT&#xD;
      with the following goals:&#xD;
&#xD;
        -  To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects&#xD;
           with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or&#xD;
           Placebo Suspension.&#xD;
&#xD;
        -  To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth&#xD;
           in subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy,&#xD;
      and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia&#xD;
      areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who&#xD;
      completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.&#xD;
&#xD;
      Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo&#xD;
      Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At&#xD;
      Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs),&#xD;
      serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria&#xD;
      in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of&#xD;
      re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in&#xD;
      this open-label study.&#xD;
&#xD;
      Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if&#xD;
      applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the&#xD;
      Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at&#xD;
      Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be&#xD;
      evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and&#xD;
      vital signs, and at Week 24, and physical examination findings&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor Decision&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">September 11, 2019</completion_date>
  <primary_completion_date type="Actual">September 11, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Severity of Alopecia Tool (SALT) Score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Relative Percent Change From Baseline SALT Score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of Response</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Physician Global Impression of Severity (PhGIS)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Alopecia Areata</condition>
  <condition>Alopecia Universalis</condition>
  <condition>Alopecia Totalis</condition>
  <arm_group>
    <arm_group_label>ATI 502 0.46% Topical Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATI 502 0.46% Topical Solution</intervention_name>
    <description>apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
    <arm_group_label>ATI 502 0.46% Topical Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet the following criteria to be eligible for participation in the&#xD;
             study:&#xD;
&#xD;
               1. Subject must be able to comprehend and willing to sign the Informed Consent Form&#xD;
                  (ICF).&#xD;
&#xD;
               2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed&#xD;
                  consent.&#xD;
&#xD;
               3. Subject has completed 24 weeks of treatment and the assessments for Visit 9 in&#xD;
                  study ATI-501-AUAT-201.&#xD;
&#xD;
               4. Subject has not experienced any AEs, SAEs or tolerability issues that met study&#xD;
                  discontinuation criteria in ATI-501-AUAT-201.&#xD;
&#xD;
               5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair&#xD;
                  regrowth from ATI-501-AUAT-201 in the opinion of the investigator.&#xD;
&#xD;
               6. If a woman of childbearing potential (WOCBP), must have a negative urine&#xD;
                  pregnancy test at Visit 1 and agree to: use a highly effective method of birth&#xD;
                  control for the duration of the study; not be planning a pregnancy during the&#xD;
                  study duration and use contraception for 30 days after last application of study&#xD;
                  medication. (Refer to Section 8.4).&#xD;
&#xD;
               7. Be in good general health and free of any known disease state or physical&#xD;
                  condition which, in the investigator's opinion, might impair evaluation of the&#xD;
                  subject or which might expose the subject to an unacceptable risk by study&#xD;
                  participation.&#xD;
&#xD;
               8. Be willing to maintain the same general hair style throughout the study period.&#xD;
                  Subjects who shave their scalp must be willing to refrain from shaving their&#xD;
                  scalp for at least one week or longer prior to each study visit, as determined by&#xD;
                  the investigator based on visible scalp hair growth. Hair trimming outside the&#xD;
                  treatment areas to maintain the current hair style is permitted.&#xD;
&#xD;
               9. Be willing and able to follow all study instructions and to attend all study&#xD;
                  visits.&#xD;
&#xD;
              10. Sexually active male subjects must agree to use a barrier method of contraception&#xD;
                  from the first application of study medication to at least 30 days after the last&#xD;
                  application of study medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects are excluded from this study if any 1 or more of the following criteria is&#xD;
             met:&#xD;
&#xD;
               1. Any study medication discontinuation criteria are met during participation in&#xD;
                  study ATI-501-AUAT-201.&#xD;
&#xD;
               2. Females who are nursing, pregnant, or planning to become pregnant for the&#xD;
                  duration of the study and up to 30 days after the last application of study&#xD;
                  medication.&#xD;
&#xD;
               3. The presence of a permanent or difficult to remove hairpiece or wig that will, in&#xD;
                  the opinion of the investigator, interfere with study assessments if not removed&#xD;
                  at each visit.&#xD;
&#xD;
               4. Sensitivity to any of the ingredients in the study medications.&#xD;
&#xD;
               5. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp&#xD;
                  for at least one week or longer prior to each study visit, as determined by the&#xD;
                  investigator based on visible scalp hair growth the duration of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator SIte</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigator Site</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>August 27, 2020</results_first_submitted>
  <results_first_submitted_qc>August 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2020</results_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</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>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03759340/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03759340/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ATI-502 0.46% Topical Solution</title>
          <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI-502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ATI-50002 0.46% Topical Solution applied twice daily.</population>
      <group_list>
        <group group_id="B1">
          <title>ATI 502 0.46% Topical Solution</title>
          <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
          </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="41.1" spread="14.36"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Current Alopecia Episode (years)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.5" spread="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Alopecia (years)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.6" spread="12.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>I - Always Burns</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II - Burns Easily</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III - Burns Moderately</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV - Burns Minimally</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>V - Rarely Burns</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VI - Never Burns</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in the Severity of Alopecia Tool (SALT) Score</title>
        <description>The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Only 8 of the 56 enrolled participants had efficacy measures on Day 169 (primary endpoint) of the ATI-502-AA-203 study. Based on this limited data set, the maintenance of, or new hair regrowth cannot be adequately assessed from this study.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Severity of Alopecia Tool (SALT) Score</title>
          <description>The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.</description>
          <population>Only 8 of the 56 enrolled participants had efficacy measures on Day 169 (primary endpoint) of the ATI-502-AA-203 study. Based on this limited data set, the maintenance of, or new hair regrowth cannot be adequately assessed from this study.</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.72" spread="35.383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Relative Percent Change From Baseline SALT Score</title>
        <description>Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Relative Percent Change From Baseline SALT Score</title>
          <description>Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.</description>
          <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit</title>
        <description>Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit</title>
          <description>Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.</description>
          <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit</title>
        <description>Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit</title>
          <description>Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.</description>
          <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Durability of Response</title>
        <description>Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Durability of Response</title>
          <description>Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.</description>
          <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Physician Global Impression of Severity (PhGIS)</title>
        <description>Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>ATI 502 0.46% Topical Solution</title>
            <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Physician Global Impression of Severity (PhGIS)</title>
          <description>Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.</description>
          <population>Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ATI 502 0.46% Topical Solution</title>
          <description>Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.&#xD;
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)</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="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="18" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </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>
    <limitations_and_caveats>The ATI-502-AA-203 study was terminated early due to lack of efficacy in a similarly designed study with ATI-502 Topical Solution. Due to the premature termination, the secondary efficacy analyses outlined in the protocol were not performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marco Cardillo, Clinical Trial Manager</name_or_title>
      <organization>Aclaris Therapeutics, Inc.</organization>
      <phone>484-540-6299</phone>
      <email>mcardillo@aclaristx.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/NCT03759340
org study id: ATI-502-AA-203
nct id: NCT03759340
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open label study of ATI-502 Topical Solution for the treatment of AA, AU, and AT
      with the following goals:

        -  To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects
           with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or
           Placebo Suspension.

        -  To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth
           in subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.
This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy,
      and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia
      areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who
      completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.

      Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo
      Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At
      Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs),
      serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria
      in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of
      re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in
      this open-label study.

      Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if
      applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the
      Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at
      Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be
      evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and
      vital signs, and at Week 24, and physical examination findings
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Severity of Alopecia Tool (SALT) Score
time frame: Baseline to Week 24
description: The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.
measure: Mean Relative Percent Change From Baseline SALT Score
time frame: Baseline to Week 24
description: Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.
measure: Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit
time frame: Baseline to Week 24
description: Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
measure: Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit
time frame: Baseline to Week 24
description: Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.
measure: Durability of Response
time frame: Baseline to Week 24
description: Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.
measure: Change From Baseline in the Physician Global Impression of Severity (PhGIS)
time frame: Baseline to Week 24
description: Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.
arm group label: ATI 502 0.46% Topical Solution
arm group type: Experimental
description: Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
intervention type: Drug
intervention name: ATI 502 0.46% Topical Solution
description: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
arm group label: ATI 502 0.46% Topical Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
sharing ipd: Undecided
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reported events: 
certain agreements: 
limitations and caveats: The ATI-502-AA-203 study was terminated early due to lack of efficacy in a similarly designed study with ATI-502 Topical Solution. Due to the premature termination, the secondary efficacy analyses outlined in the protocol were not performed.
point of contact: 