<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/NCT03304470</url>
  </required_header>
  <id_info>
    <org_study_id>ATx201-003</org_study_id>
    <nct_id>NCT03304470</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis</brief_title>
  <official_title>A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNION therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNION therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle&#xD;
      controlled study, with each individual receiving both active and vehicle treatment.&#xD;
      Approximately 30 subjects with moderate atopic dermatitis will receive topically applied&#xD;
      ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without&#xD;
      occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate&#xD;
      atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands,&#xD;
      and feet, ideally from the same anatomical location).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of local and systemic treatment-emergent adverse events</measure>
    <time_frame>34 days</time_frame>
    <description># of TEAEs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.</measure>
    <time_frame>22 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22</measure>
    <time_frame>22 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in skin barrier and biomarker levels at Day 22</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>ATx201 2% CREAM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 Cream Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 2% Cream</intervention_name>
    <description>Anhydrous Cream</description>
    <arm_group_label>ATx201 2% CREAM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 Cream Vehicle</intervention_name>
    <description>Anhydrous Cream</description>
    <arm_group_label>ATx201 Cream Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically confirmed diagnosis of active atopic dermatitis&#xD;
&#xD;
          -  at least a 6-month history of atopic dermatitis and had no significant flares in&#xD;
             atopic dermatitis for at least 4 weeks before screening&#xD;
&#xD;
          -  ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at&#xD;
             least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  breastfeeding, pregnant, or is planning to become pregnant during the study.&#xD;
&#xD;
          -  clinically infected atopic dermatitis&#xD;
&#xD;
          -  Fitzpatrick's Skin Phototype ≥5&#xD;
&#xD;
          -  Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the&#xD;
             target lesion areas&#xD;
&#xD;
          -  known to have immune deficiency or is immunocompromised.&#xD;
&#xD;
          -  history of cancer or lymphoproliferative disease within 5 years prior to Day 1.&#xD;
&#xD;
          -  major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the&#xD;
             study.&#xD;
&#xD;
          -  clinically significant medical condition or physical/laboratory/vital signs&#xD;
             abnormality that would, in the opinion of the investigator, put the subject at undue&#xD;
             risk or interfere with interpretation of study results.&#xD;
&#xD;
          -  known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or&#xD;
             infection with human immunodeficiency virus).&#xD;
&#xD;
          -  used hydroxyzine or diphenhydramine within 1 week prior to Day 1.&#xD;
&#xD;
          -  used dupilumab within 12 weeks prior to Day 1.&#xD;
&#xD;
          -  received any nonbiological investigational product or device within 4 weeks prior to&#xD;
             Day 1&#xD;
&#xD;
          -  used crisaborole and any other topical PDE-4 inhibitor within 4 weeks prior to Day 1.&#xD;
&#xD;
          -  used doxepin within 1 week prior to Day 1.&#xD;
&#xD;
          -  used topical products containing urea within 1 week prior to Day 1.&#xD;
&#xD;
          -  used nonurea-containing emollient anywhere on the body from 1 day before Day 1.&#xD;
&#xD;
          -  used systemic antibiotics or topical antibiotics on the treated areas within 2 weeks&#xD;
             prior to Day 1.&#xD;
&#xD;
          -  used any topical medicated treatment for atopic dermatitis within 2 weeks prior to Day&#xD;
             1, including, but not limited to, topical corticosteroids, calcineurin inhibitors,&#xD;
             tars, bleach, antimicrobials, medical devices, and bleach baths.&#xD;
&#xD;
          -  used systemic treatments (other than biologics) that could affect atopic dermatitis&#xD;
             less than 4 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors,&#xD;
             methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine,&#xD;
             oral/injectable corticosteroids).&#xD;
&#xD;
          -  received any marketed or investigational biological agent within 12 weeks or 5&#xD;
             half-lives (whichever is longer) prior to Day 1.&#xD;
&#xD;
          -  excessive sun exposure, is planning a trip to a sunny climate, has received&#xD;
             ultraviolet phototherapy, or has used tanning booths within 4 weeks prior to Day 1, or&#xD;
             is not willing to minimize natural and artificial sunlight exposure during the study.&#xD;
             Use of sunscreen products (excluding the treatment areas) and protective apparel are&#xD;
             recommended when exposure cannot be avoided.&#xD;
&#xD;
          -  known or suspected allergy to ATx201 or any component of the investigational product.&#xD;
&#xD;
          -  known history of clinically significant drug or alcohol abuse in the last year prior&#xD;
             to Day 1.&#xD;
&#xD;
          -  history of an allergic reaction or significant sensitivity to lidocaine or other local&#xD;
             anesthetics.&#xD;
&#xD;
          -  history of hypertrophic scarring or keloid formation in scars or suture sites.&#xD;
&#xD;
          -  taking anticoagulant medication, such as heparin, low molecular weight-heparin,&#xD;
             warfarin, or antiplatelets (nonsteroidal anti-inflammatory drugs and aspirin ≤81 mg&#xD;
             will not be considered antiplatelets) within 2 weeks prior to Day 1, or has a&#xD;
             contraindication to skin biopsies.&#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>Philippe Prokocimer</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor CMO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innovaderm Research Inc</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2K 4L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</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>
  <!-- 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/NCT03304470
org study id: ATx201-003
nct id: NCT03304470
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle
      controlled study, with each individual receiving both active and vehicle treatment.
      Approximately 30 subjects with moderate atopic dermatitis will receive topically applied
      ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without
      occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate
      atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands,
      and feet, ideally from the same anatomical location).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence of local and systemic treatment-emergent adverse events
time frame: 34 days
description: # of TEAEs
measure: Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.
time frame: 22 Days
measure: Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22
time frame: 22 Days
measure: Change from baseline in skin barrier and biomarker levels at Day 22
time frame: Day 22
arm group label: ATx201 2% CREAM
arm group type: Experimental
arm group label: ATx201 Cream Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: ATx201 2% Cream
description: Anhydrous Cream
arm group label: ATx201 2% CREAM
intervention type: Drug
intervention name: ATx201 Cream Vehicle
description: Anhydrous Cream
arm group label: ATx201 Cream Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Prokocimer
role: Study Director
affiliation: Sponsor CMO
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No