<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/NCT03775434</url>
  </required_header>
  <id_info>
    <org_study_id>ADB244-002</org_study_id>
    <nct_id>NCT03775434</nct_id>
  </id_info>
  <brief_title>A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis</brief_title>
  <official_title>An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novella Clinical</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>
      An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess&#xD;
      safety in pediatric subjects aged 2 to 17 years with atopic dermatitis&#xD;
&#xD;
      Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244&#xD;
      Phase 1b&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244&#xD;
      application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.&#xD;
&#xD;
      Number of Subjects:&#xD;
&#xD;
      The study will enroll 36 subjects in 3 cohorts of 12 subjects:&#xD;
&#xD;
        -  Cohort 1: subjects aged 2 to 5 years.&#xD;
&#xD;
        -  Cohort 2: subjects aged 6 to 11 years.&#xD;
&#xD;
        -  Cohort 3, subjects aged 12 to 17 years.&#xD;
&#xD;
      At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis,&#xD;
      as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more&#xD;
      than 60% body surface area and a Validated Investigator Global Assessment for Atopic&#xD;
      Dermatitis (vIGA-AD) scale of 2 or 3.&#xD;
&#xD;
      The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening&#xD;
      visit between Days -21 and -14. If all eligibility criteria and none of the exclusion&#xD;
      criteria are met, subjects will be enrolled into the study and will be required to undergo a&#xD;
      14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the&#xD;
      Baseline assessments will be performed before application of the first dose.&#xD;
&#xD;
      On confirmation of continued eligibility the subject and parent or guardian of the subject&#xD;
      will be coached on how to apply medication, depending on the affected areas. They will be&#xD;
      instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.&#xD;
&#xD;
      The first dose will be applied in the clinic under the supervision of clinical staff. Details&#xD;
      of dose administration will be recorded in the study diary provided. The subjects with their&#xD;
      parent or guardian will return to the study center on Days 7, 14, and 21 for completion of&#xD;
      study assessments.&#xD;
&#xD;
      There will be a final study visit on Day 28, this will be defined as the end of the study for&#xD;
      the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be&#xD;
      a period of confinement in the study center all visits will be outpatient visits. Safety&#xD;
      monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will&#xD;
      be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 18, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subjects will receive active product</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is a single arm open label study. Subjects will be assigned to the study treatment arm. Each participant will be scheduled to receive investigational product (IP).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically significant changes from baseline in physical exam.</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT, Lyphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremeties, and other). Clinical significance of the physical exam will be determined at investigator's discretion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically significant changes from baseline in Vital Signs</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Vital signs (temperature, respiratory rate, and pulse, ) will be obtained. Clinical significance of vital signs will be determined at the investigator's discretion.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>The vIGA-AD is a physician assessment ranking of Atopic Dermatitis symptoms from 0-clear, to 4- severe</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Area Severity Index (EASI) score.</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Patient Oriented Eczema Measure (POEM total score and each of the 7 components).</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>This survey is 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in patient reported outcome (self-reported ItchMan scale).</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>The Burn Man Itch Scale is used as a self report tool for subjects to indicate how itchy the area of atopic dermatitis feels at the timepoints during the study. It's reported on a scale between 0-comfortable, no itch and 4-Itches most terribly; impossible to sit still; concentrate.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Eczema</condition>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>B244</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>B244 suspension in 30ml/bottle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental: B244</intervention_name>
    <description>B244 suspension in 30ml/bottle</description>
    <arm_group_label>B244</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are eligible to be included in the study only if all of the following&#xD;
             criteria apply:&#xD;
&#xD;
               1. Male and female subjects 2 to 17 years of age, inclusive.&#xD;
&#xD;
               2. Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka&#xD;
                  criteria.&#xD;
&#xD;
               3. A minimum of 10% but no more than 60% of the subjects' body surface area (see&#xD;
                  Appendix 6 for guidance) is affected by atopic dermatitis (affected is defined by&#xD;
                  physical examination findings: erythema, edema, scaling, lichenification, and&#xD;
                  excoriation; with the excoriation serving as the physical examination correlate&#xD;
                  of pruritus).&#xD;
&#xD;
               4. A vIGA-AD scale of 2 or 3 at Screening and Baseline.&#xD;
&#xD;
               5. Subject, or the parent or guardian, to provide written informed consent and&#xD;
                  authorization for protected health information disclosure.&#xD;
&#xD;
               6. Subjects must be generally in good health based on Investigator's assessment&#xD;
                  (other than atopic dermatitis).&#xD;
&#xD;
               7. Normal vital signs, or with no clinically significant vital signs that in the&#xD;
                  opinion of the Investigator, would place the subject at increased risk or would&#xD;
                  confound the objectives of the study.&#xD;
&#xD;
               8. Females must not be pregnant, as confirmed by negative urine pregnancy testing.&#xD;
                  Female subjects aged ≥11 years old, or female patients &lt;11 years old who have&#xD;
                  started menstruating, will have urinary pregnancy test performed at Screening and&#xD;
                  prior to the first dose with negative results in order to participate in the&#xD;
                  study. Females must either practice abstinence from heterosexual contact or use&#xD;
                  one of the highly effective contraceptive options described in the Appendix 5.&#xD;
&#xD;
               9. Male subjects of reproductive potential, must be willing to practice effective&#xD;
                  contraception during the study while receiving study treatment from Day 1 and for&#xD;
                  7 days after the last study visit (Day 28).&#xD;
&#xD;
              10. Ability to comprehend and comply with study procedures.&#xD;
&#xD;
              11. Agree to commit to participate in the current protocol.&#xD;
&#xD;
              12. Provide written informed consent prior to any study procedure being performed.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
                  Subjects are excluded from the study if any of the following criteria apply:&#xD;
&#xD;
               1. Clinically significant physical or mental disorder which, in the opinion of the&#xD;
                  Investigator, would place the subject at increased risk or would confound the&#xD;
                  objectives of the study.&#xD;
&#xD;
               2. Subjects with atopic dermatitis on the face only.&#xD;
&#xD;
               3. Active cutaneous bacterial, viral or fungal infection in any treatment area at&#xD;
                  Baseline (eg, clinically infected atopic dermatitis).&#xD;
&#xD;
               4. History or presence of immunological deficiencies or diseases, organ transplant,&#xD;
                  human immunodeficiency virus (HIV), diabetes, malignancy, malignant or&#xD;
                  pre-malignant skin conditions, serious active or recurrent infection, systemic&#xD;
                  immunosuppressive regimens, clinically significant renal disease severe hepatic&#xD;
                  disorders, or other severe uncontrolled conditions (eg, drug or alcohol abuse),&#xD;
                  that are significant and/or that may pose a health risk to the subject in the&#xD;
                  study or may have an impact on the study assessments.&#xD;
&#xD;
               5. Unstable atopic dermatitis or a consistent requirement for high-potency&#xD;
                  corticosteroids (class I-III steroids).&#xD;
&#xD;
               6. Active systemic or localized infection (including infected AD).&#xD;
&#xD;
               7. Subjects unable to comply with the excluded medication/therapy restriction&#xD;
&#xD;
               8. Known hypersensitivity to the study treatment.&#xD;
&#xD;
               9. Known to have hepatitis B, hepatitis C or HIV I or II tests. Details will be&#xD;
                  recorded in medical history, a blood sample will not be collected for&#xD;
                  confirmation.&#xD;
&#xD;
              10. Female subject who is pregnant, breastfeeding, or considering pregnancy during&#xD;
                  the study.&#xD;
&#xD;
              11. Any skin condition which in the Investigator's opinion may interfere with the&#xD;
                  evaluation of atopic dermatitis.&#xD;
&#xD;
              12. Use of any investigational drugs within the previous 30 days prior to dosing or&#xD;
                  within a period of less than 5 times the drug's half-life, whichever is longer.&#xD;
&#xD;
              13. Use of any biologic within a period of 5 times its half-life.&#xD;
&#xD;
              14. Children or relatives of the Sponsor, clinical research organization, or the&#xD;
                  Study Site personnel are excluded from participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</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 Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Trial Associates</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L.A. Universal Research Center, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indiana Clinical Trials Center</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Specialists, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, INC</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 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>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>
  <pending_results>
    <submitted>July 20, 2022</submitted>
    <returned>May 25, 2023</returned>
    <submitted>June 15, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03775434
org study id: ADB244-002
nct id: NCT03775434
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess
      safety in pediatric subjects aged 2 to 17 years with atopic dermatitis

      Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244
      Phase 1b
This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244
      application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.

      Number of Subjects:

      The study will enroll 36 subjects in 3 cohorts of 12 subjects:

        -  Cohort 1: subjects aged 2 to 5 years.

        -  Cohort 2: subjects aged 6 to 11 years.

        -  Cohort 3, subjects aged 12 to 17 years.

      At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis,
      as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more
      than 60% body surface area and a Validated Investigator Global Assessment for Atopic
      Dermatitis (vIGA-AD) scale of 2 or 3.

      The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening
      visit between Days -21 and -14. If all eligibility criteria and none of the exclusion
      criteria are met, subjects will be enrolled into the study and will be required to undergo a
      14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the
      Baseline assessments will be performed before application of the first dose.

      On confirmation of continued eligibility the subject and parent or guardian of the subject
      will be coached on how to apply medication, depending on the affected areas. They will be
      instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.

      The first dose will be applied in the clinic under the supervision of clinical staff. Details
      of dose administration will be recorded in the study diary provided. The subjects with their
      parent or guardian will return to the study center on Days 7, 14, and 21 for completion of
      study assessments.

      There will be a final study visit on Day 28, this will be defined as the end of the study for
      the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be
      a period of confinement in the study center all visits will be outpatient visits. Safety
      monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will
      be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects will receive active product
primary purpose: Treatment
masking: None (Open Label)
masking description: This is a single arm open label study. Subjects will be assigned to the study treatment arm. Each participant will be scheduled to receive investigational product (IP).
measure: Incidence of treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
time frame: Baseline to Day 28
description: Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
measure: Clinically significant changes from baseline in physical exam.
time frame: Baseline to Day 28
description: A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT, Lyphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremeties, and other). Clinical significance of the physical exam will be determined at investigator's discretion.
measure: Clinically significant changes from baseline in Vital Signs
time frame: Baseline to Day 28
description: Vital signs (temperature, respiratory rate, and pulse, ) will be obtained. Clinical significance of vital signs will be determined at the investigator's discretion.
measure: Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
time frame: Baseline to Day 28
description: The vIGA-AD is a physician assessment ranking of Atopic Dermatitis symptoms from 0-clear, to 4- severe
measure: Changes in Area Severity Index (EASI) score.
time frame: Baseline to Day 28
description: The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
measure: Changes in Patient Oriented Eczema Measure (POEM total score and each of the 7 components).
time frame: Baseline to Day 28
description: This survey is 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
measure: Changes in patient reported outcome (self-reported ItchMan scale).
time frame: Baseline to Day 28
description: The Burn Man Itch Scale is used as a self report tool for subjects to indicate how itchy the area of atopic dermatitis feels at the timepoints during the study. It's reported on a scale between 0-comfortable, no itch and 4-Itches most terribly; impossible to sit still; concentrate.
arm group label: B244
arm group type: Experimental
description: B244 suspension in 30ml/bottle
intervention type: Drug
intervention name: Experimental: B244
description: B244 suspension in 30ml/bottle
arm group label: B244
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
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 Therapeutics
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
submitted: July 20, 2022
returned: May 25, 2023
submitted: June 15, 2023