<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/NCT03293030</url>
  </required_header>
  <id_info>
    <org_study_id>Dupilumab Immunogenetics</org_study_id>
    <nct_id>NCT03293030</nct_id>
  </id_info>
  <brief_title>Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis</brief_title>
  <official_title>Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm, open-label study to examine the effect of dupilumab on the immunologic&#xD;
      and genetic environment within atopic dermatitis skin lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifteen subjects with moderate to severe AD will receive dupilumab for a treatment period of&#xD;
      52 weeks (i.e. last injection on week 50). Biopsy samples from AD subjects and surgical&#xD;
      discard samples will undergo molecular profiling. Skin swabs and stool samples will be&#xD;
      collected and banked for future analysis. The reason to treat patients for 52 weeks is to&#xD;
      have the ability to correlate early molecular events with clinical outcomes at week 52.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD4+ T effector cells expressing IL-4</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage change from pre-treatment baseline of CD4+ T effector cells expressing IL-4 at weeks 2, 4, 12 in dupilumab-treated patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of differentially expressed genes and pathways</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of differentially expressed genes and pathways in each cell population at weeks 2, 4, 12 compared to pre-treatment baseline using RNA-seq.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiome</measure>
    <time_frame>52 weeks</time_frame>
    <description>Microbiome samples from skin and stool at weeks 0, 2, 4, 12, and 52 will be banked for future analysis.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Atopic Dermatitis Eczema</condition>
  <condition>Eczema</condition>
  <condition>Atopic Dermatitis and Related Conditions</condition>
  <arm_group>
    <arm_group_label>Dupilumab treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dupilumab</intervention_name>
    <description>Dupilumab treatment</description>
    <arm_group_label>Dupilumab treatment</arm_group_label>
    <other_name>Dupixent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide written informed consent and comply with the protocol.&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Diagnosis of chronic atopic dermatitis for at least 3 years prior to enrollment.&#xD;
&#xD;
          -  Subject is considered a candidate for phototherapy or systemic therapy&#xD;
&#xD;
          -  Eczema Area and Severity Index (EASI) score ≥ 16&#xD;
&#xD;
          -  Investigator Global Assessment (IGA) ≥ 3&#xD;
&#xD;
          -  10% body surface area (BSA) or greater&#xD;
&#xD;
          -  Subject is unlikely to conceive due to male, post-menopausal, or using adequate&#xD;
             contraceptive (barrier, hormonal, implant, or permanent sterilization methods).&#xD;
&#xD;
          -  Physical exam within clinically acceptable limits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is unable to provide written informed consent or comply with the protocol.&#xD;
&#xD;
          -  Subject is younger than 18 years of age.&#xD;
&#xD;
          -  Subject has had atopic dermatitis for less than 3 years prior to enrollment.&#xD;
&#xD;
          -  Subject with mild atopic dermatitis (EASI&lt;16 and IGA&lt;3) or is not a candidate for&#xD;
             phototherapy or systemic treatments.&#xD;
&#xD;
          -  Subject with current, or a history of, severe atopic dermatitis well controlled on&#xD;
             current therapy.&#xD;
&#xD;
          -  Serious known infection.&#xD;
&#xD;
          -  History of immunosuppression (including human immunodeficiency virus (HIV))&#xD;
&#xD;
          -  History of malignancy within 5 years before the screening visit, except completely&#xD;
             treated in situ carcinoma of the cervix, completely treated and resolved&#xD;
             non-metastatic squamous or basal cell carcinoma of the skin.&#xD;
&#xD;
          -  Severe concomitant illnesses.&#xD;
&#xD;
          -  Having used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,&#xD;
             cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,&#xD;
             methotrexate, etc.) or phototherapy within 4 weeks before the baseline visit.&#xD;
&#xD;
          -  Treatment with topical corticosteroid or topical calcineurin inhibitor within 1 week&#xD;
             before the baseline visit.&#xD;
&#xD;
          -  Treatment with any cell-depleting agents including but not limited to rituximab:&#xD;
             within 6 months before the baseline visit, or until lymphocyte count returns to&#xD;
             normal, whichever is longer, or use of other biologics: within 5 half-lives (if known)&#xD;
             or 16 weeks prior to baseline visit, whichever is longer.&#xD;
&#xD;
          -  Physical or laboratory exam not within clinically acceptable limits.&#xD;
&#xD;
          -  Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her&#xD;
             from safely participating in this study or interfere with the evaluation of the&#xD;
             subject's atopic dermatitis.&#xD;
&#xD;
          -  History of known or suspected intolerance to any of the ingredients of the&#xD;
             investigational study product.&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive hCG laboratory test (&gt;10 mIU/mL).&#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>Wilson Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mimi Chung</last_name>
    <phone>415-476-4019</phone>
    <email>mimi.chung@ucsf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCSF Psoriasis and Skin Treatment Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quinn Thibodeaux, MD</last_name>
      <phone>415-944-7618</phone>
      <email>psoriasis@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Wilson Liao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atopic dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>dupilumab</keyword>
  <keyword>atopic eczema</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/NCT03293030
org study id: Dupilumab Immunogenetics
nct id: NCT03293030
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a single-arm, open-label study to examine the effect of dupilumab on the immunologic
      and genetic environment within atopic dermatitis skin lesions.
Fifteen subjects with moderate to severe AD will receive dupilumab for a treatment period of
      52 weeks (i.e. last injection on week 50). Biopsy samples from AD subjects and surgical
      discard samples will undergo molecular profiling. Skin swabs and stool samples will be
      collected and banked for future analysis. The reason to treat patients for 52 weeks is to
      have the ability to correlate early molecular events with clinical outcomes at week 52.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CD4+ T effector cells expressing IL-4
time frame: 12 weeks
description: Percentage change from pre-treatment baseline of CD4+ T effector cells expressing IL-4 at weeks 2, 4, 12 in dupilumab-treated patients.
measure: Number of differentially expressed genes and pathways
time frame: 12 weeks
description: Number of differentially expressed genes and pathways in each cell population at weeks 2, 4, 12 compared to pre-treatment baseline using RNA-seq.
measure: Microbiome
time frame: 52 weeks
description: Microbiome samples from skin and stool at weeks 0, 2, 4, 12, and 52 will be banked for future analysis.
arm group label: Dupilumab treatment
arm group type: Experimental
description: 15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling.
intervention type: Drug
intervention name: Dupilumab
description: Dupilumab treatment
arm group label: Dupilumab treatment
other name: Dupixent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wilson Liao, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Mimi Chung
phone: 415-476-4019
email: mimi.chung@ucsf.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No