<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/NCT03235024</url>
  </required_header>
  <id_info>
    <org_study_id>ADB244-001</org_study_id>
    <nct_id>NCT03235024</nct_id>
  </id_info>
  <brief_title>Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis</brief_title>
  <official_title>A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Veristat, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AOBiome LLC</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 Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II&#xD;
      trial, comparing the effect of twice daily B244 application for 28 days vs vehicle&#xD;
      application on treatment of mild to moderate AD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II&#xD;
      trial, comparing the effect of twice daily B244 application for 28 days vs vehicle&#xD;
      application on treatment of mild to moderate AD&#xD;
&#xD;
      At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the&#xD;
      Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface&#xD;
      area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the&#xD;
      VAS scale (at least moderate).&#xD;
&#xD;
      The total duration of the study will be approximately 9 weeks. Participants will report for a&#xD;
      Screening visit and if all inclusion criteria are met, subjects will go through a two week&#xD;
      washout phase before reporting for a Baseline visit.&#xD;
&#xD;
      Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be&#xD;
      conducted at Day 42 (Week 6).&#xD;
&#xD;
      Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual&#xD;
      Analog Scale (VAS).&#xD;
&#xD;
      Blood and urine samples will be collected for standard safety laboratory tests and effect of&#xD;
      the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the&#xD;
      study.&#xD;
&#xD;
      Investigators plan to enroll approximately 130 total patients.&#xD;
&#xD;
      Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system).&#xD;
Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>Baseline to Day 42</time_frame>
    <description>Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Skindex 16 Score Between the Active and Vehicle Group</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the IGA Score Between the Active and Vehicle Groups</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in Biomarkers Between Active and Vehicle Groups.</measure>
    <time_frame>Baseline and Day 28</time_frame>
    <description>To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbial Content</measure>
    <time_frame>Baseline and Day 28</time_frame>
    <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Atopic Dermatitis Eczema</condition>
  <arm_group>
    <arm_group_label>B244</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>B244 suspension in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>B244</intervention_name>
    <description>B244 suspension</description>
    <arm_group_label>B244</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle suspension</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥18 years of age&#xD;
&#xD;
          -  In good general health as determined by a thorough medical history and physical&#xD;
             examination, and vital signs&#xD;
&#xD;
          -  Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of&#xD;
             Hanifin and Rajka&#xD;
&#xD;
          -  Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21&#xD;
&#xD;
          -  A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus&#xD;
&#xD;
          -  A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic&#xD;
             dermatitis (affected is defined by physical examination findings: erythema, edema,&#xD;
             scaling, lichenification, excoriation, with the excoriation serving as the physical&#xD;
             examination correlate of pruritus)&#xD;
&#xD;
          -  An IGA score of 2-3&#xD;
&#xD;
          -  Patient has a history of AD for ≥12 months&#xD;
&#xD;
          -  Ability to read and understand English and to provide written informed consent and&#xD;
             authorization for protected health information disclosure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating women by urine pregnancy testing&#xD;
&#xD;
          -  Subjects with any significant clinical abnormalities which may interfere with study&#xD;
             participation&#xD;
&#xD;
          -  Any skin condition which may interfere with evaluation of AD&#xD;
&#xD;
          -  Atopic dermatitis only on the head or scalp&#xD;
&#xD;
          -  Subjects with Atopic dermatitis on the face&#xD;
&#xD;
          -  Unstable or actively infected atopic dermatitis&#xD;
&#xD;
          -  Patients suffering from pruritus from conditions other than AD&#xD;
&#xD;
          -  Patients with chronic pruritus due to systemic disease&#xD;
&#xD;
          -  Patients with conditions requiring inhaled steroids&#xD;
&#xD;
          -  Have concurrent skin disease of such severity in the study area that it could&#xD;
             interfere with the study evaluation&#xD;
&#xD;
          -  Have active skin infections on the treatment area&#xD;
&#xD;
          -  Have received or planning to receive topical corticosteroids, topical coal tar,&#xD;
             topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics&#xD;
             or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy,&#xD;
             oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics,&#xD;
             glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents,&#xD;
             systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within&#xD;
             2 weeks of Baseline visit.&#xD;
&#xD;
          -  Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex®&#xD;
             and Trexall™ or its generic versions such as Methotrexate&#xD;
&#xD;
          -  History of being seropositive for human immunodeficiency virus (HIV) at screening by&#xD;
             laboratory testing at Screening&#xD;
&#xD;
          -  History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive&#xD;
             Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening&#xD;
&#xD;
          -  History of renal disease&#xD;
&#xD;
          -  Use of any investigational drugs within the previous 30 days prior to dosing or within&#xD;
             a period of less than five times the drug's half-life, whichever is longer&#xD;
&#xD;
          -  Use of any biologic within a period of 5 times its half-life&#xD;
&#xD;
          -  Use of vinegar or bleach baths within 2 weeks of starting 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>
  <overall_official>
    <last_name>Judith Ng-Cashin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Spiros Jamas, ScD</last_name>
    <role>Study Director</role>
    <affiliation>AOBiome LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Research Associates</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encino Research Center</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neostart Corporation d.b.a AGA Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solution, Inc</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research Corp.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research Miramar</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solution, Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Trials of Florida, Inc.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DeNova Research dba Arano, LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarkston Skin Research</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48349</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSearch Clinical Trials</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LoveLace Scientific Resources</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Sooner Research</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paddington Testing Co.</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2022</results_first_posted>
  <disposition_first_submitted>July 28, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 6, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 10, 2022</disposition_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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>October 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03235024/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03235024/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>B244</title>
          <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) population included all randomized subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>B244</title>
          <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="61"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="122"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="98"/>
                  </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="36"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="42"/>
                  </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="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.420" spread="24.9020"/>
                    <measurement group_id="B2" value="85.542" spread="22.8794"/>
                    <measurement group_id="B3" value="85.481" spread="23.8132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.027" spread="9.2237"/>
                    <measurement group_id="B2" value="30.551" spread="7.0286"/>
                    <measurement group_id="B3" value="30.289" spread="8.1702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;20 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20 to &lt;25 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>25 to &lt;30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
        <description>Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.</description>
        <time_frame>Baseline to Day 42</time_frame>
        <population>Intent to Treat (ITT) population included all randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
          <description>Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.</description>
          <population>Intent to Treat (ITT) population included all randomized subjects.</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="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Least 1 Treatment-Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Least 1 Treatment-Related Grade 3 or 4 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Least 1 Treatment-Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups</title>
        <description>EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups</title>
          <description>EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="4.46"/>
                    <measurement group_id="O2" value="-5.9" spread="5.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group</title>
        <description>VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group</title>
          <description>VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="2.23"/>
                    <measurement group_id="O2" value="-0.6" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.81"/>
                    <measurement group_id="O2" value="-1.4" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A sample size of 52 per group would achieve &gt;80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.</non_inferiority_desc>
            <p_value>0.0228</p_value>
            <p_value_desc>At Week 2</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in the Skindex 16 Score Between the Active and Vehicle Group</title>
        <description>The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Skindex 16 Score Between the Active and Vehicle Group</title>
          <description>The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="5.74"/>
                    <measurement group_id="O2" value="-0.8" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in the IGA Score Between the Active and Vehicle Groups</title>
        <description>IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the IGA Score Between the Active and Vehicle Groups</title>
          <description>IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.82"/>
                    <measurement group_id="O2" value="-0.7" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group</title>
        <description>Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28 with data collected from Actigraphy watches (subjects with missing data were excluded from analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group</title>
          <description>Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28 with data collected from Actigraphy watches (subjects with missing data were excluded from analysis).</population>
          <units>average scratching events per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="8.26"/>
                    <measurement group_id="O2" value="3" spread="7.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Difference in Biomarkers Between Active and Vehicle Groups.</title>
        <description>To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.</description>
        <time_frame>Baseline and Day 28</time_frame>
        <population>Data was not collected for this exploratory endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Biomarkers Between Active and Vehicle Groups.</title>
          <description>To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.</description>
          <population>Data was not collected for this exploratory endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Microbial Content</title>
        <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
        <time_frame>Baseline and Day 28</time_frame>
        <population>Data was not collected for this exploratory endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>B244</title>
            <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Microbial Content</title>
          <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
          <population>Data was not collected for this exploratory endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Week 6.</time_frame>
      <desc>All AEs occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. Adverse events believed to be possibly related to IP must have been followed until their resolution.</desc>
      <group_list>
        <group group_id="E1">
          <title>B244</title>
          <description>B244 suspension (4x10E9 cells/ml) in 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
B244: B244 suspension</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle, 30ml/bottle&#xD;
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day&#xD;
Vehicle: Vehicle suspension</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="16" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Lip Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Superinfection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemeoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning Sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </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>Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hyun Kim, Vice President Clinical Operations</name_or_title>
      <organization>AOBiome Therapeutics</organization>
      <phone>617-639-9980</phone>
      <email>hkim@aobiome.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/NCT03235024
org study id: ADB244-001
nct id: NCT03235024
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II
      trial, comparing the effect of twice daily B244 application for 28 days vs vehicle
      application on treatment of mild to moderate AD
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II
      trial, comparing the effect of twice daily B244 application for 28 days vs vehicle
      application on treatment of mild to moderate AD

      At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the
      Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface
      area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the
      VAS scale (at least moderate).

      The total duration of the study will be approximately 9 weeks. Participants will report for a
      Screening visit and if all inclusion criteria are met, subjects will go through a two week
      washout phase before reporting for a Baseline visit.

      Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be
      conducted at Day 42 (Week 6).

      Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual
      Analog Scale (VAS).

      Blood and urine samples will be collected for standard safety laboratory tests and effect of
      the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the
      study.

      Investigators plan to enroll approximately 130 total patients.

      Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system).
Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
time frame: Baseline to Day 42
description: Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
measure: Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
time frame: Baseline to Day 28
description: EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
measure: Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group
time frame: Baseline to Day 28
description: VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.
measure: Change in the Skindex 16 Score Between the Active and Vehicle Group
time frame: Baseline to Day 28
description: The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
measure: Change in the IGA Score Between the Active and Vehicle Groups
time frame: Baseline to Day 28
description: IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
measure: Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group
time frame: Baseline to Day 28
description: Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.
measure: Difference in Biomarkers Between Active and Vehicle Groups.
time frame: Baseline and Day 28
description: To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.
measure: Microbial Content
time frame: Baseline and Day 28
description: Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
arm group label: B244
arm group type: Active Comparator
description: B244 suspension in 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle, 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
intervention type: Biological
intervention name: B244
description: B244 suspension
arm group label: B244
intervention type: Biological
intervention name: Vehicle
description: Vehicle suspension
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith Ng-Cashin, MD
role: Study Director
affiliation: Chief Medical Officer
last name: Spiros Jamas, ScD
role: Study Director
affiliation: AOBiome LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 