<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/NCT04504279</url>
  </required_header>
  <id_info>
    <org_study_id>FB401-01</org_study_id>
    <nct_id>NCT04504279</nct_id>
  </id_info>
  <brief_title>Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Forte Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Forte Biosciences, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs&#xD;
      and symptoms following the application of FB-401 in patients 2 years or older with mild to&#xD;
      moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will&#xD;
      be assessed by assessment of the skin and patient reports.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2020</start_date>
  <completion_date type="Actual">August 19, 2021</completion_date>
  <primary_completion_date type="Actual">July 14, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EASI 50</measure>
    <time_frame>16 weeks</time_frame>
    <description>The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Includes percent change in EASI</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percent change in EASI score is measured from baseline to Week 16</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>FB-401</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FB-401 applied topically for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo applied topically for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FB-401</intervention_name>
    <description>Topical application</description>
    <arm_group_label>FB-401</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Vehicle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, ≥ 2 years of age&#xD;
&#xD;
          -  Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that&#xD;
             has been present for ≥ 3 months before the screening visit&#xD;
&#xD;
          -  Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening&#xD;
             and Baseline/Day 1 using the validated IGA scale for atopic dermatitis&#xD;
&#xD;
          -  EASI score ≥ 5 at the screening and the Baseline visit&#xD;
&#xD;
          -  5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the&#xD;
             screening and the baseline visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment within 4 weeks prior to the baseline visit with any of the&#xD;
             following:&#xD;
&#xD;
          -  Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous,&#xD;
             oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate,&#xD;
             cyclosporine&#xD;
&#xD;
          -  Phototherapy or photo chemotherapy for atopic dermatitis&#xD;
&#xD;
          -  Previous treatment within 1 week prior to the baseline visit with any of the&#xD;
             following:&#xD;
&#xD;
          -  Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or&#xD;
             topical calcineurin inhibitors&#xD;
&#xD;
          -  Topical phosphodiesterase type 4 (PDE4) inhibitor&#xD;
&#xD;
          -  Use of emollients other than provided for the study&#xD;
&#xD;
          -  Bleach baths&#xD;
&#xD;
          -  Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline&#xD;
             visit with Janus kinase inhibitors or other investigational drug&#xD;
&#xD;
          -  Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with&#xD;
             dupilumab or other biologic agent to treat atopic dermatitis&#xD;
&#xD;
          -  Within 1 year prior to the baseline visit with any live bacterial therapy&#xD;
&#xD;
          -  Pregnant (or planning to become pregnant during the period of the study) or lactating&#xD;
             females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>First OC Dermatology</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology Clinical Research, Inc.</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multi-Specialty Research Associates, Inc.</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedaPhase, Inc.</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>Clarksville</city>
        <state>Indiana</state>
        <zip>47129</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>DS Research</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence J. Green MD LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>New Brighton</city>
        <state>Minnesota</state>
        <zip>55112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Children's Health Research Institute</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Consulting Services, PLLC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KGL Skin Study Center LLC</name>
      <address>
        <city>Newtown Square</city>
        <state>Pennsylvania</state>
        <zip>19073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellaire Dermatology Associates</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Dermatology and Laser Specialists</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.</citation>
    <PMID>29720571</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atopic dermatitis</keyword>
  <keyword>microbiome</keyword>
  <keyword>probiotic</keyword>
  <keyword>commensal Gram-negative bacteria</keyword>
  <keyword>transdermal water loss</keyword>
  <keyword>allergic diseases</keyword>
  <keyword>dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>skin diseases</keyword>
  <keyword>skin diseases, eczematous</keyword>
  <keyword>immune system diseases</keyword>
  <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>
  <!-- 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/NCT04504279
org study id: FB401-01
nct id: NCT04504279
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs
      and symptoms following the application of FB-401 in patients 2 years or older with mild to
      moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will
      be assessed by assessment of the skin and patient reports.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: EASI 50
time frame: 16 weeks
description: The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
measure: Includes percent change in EASI
time frame: 16 weeks
description: Percent change in EASI score is measured from baseline to Week 16
arm group label: FB-401
arm group type: Experimental
description: FB-401 applied topically for 16 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo applied topically for 16 weeks.
intervention type: Biological
intervention name: FB-401
description: Topical application
arm group label: FB-401
intervention type: Biological
intervention name: Placebo
description: Vehicle
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
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facility: 
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country: United States
citation: Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
PMID: 29720571
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No