<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/NCT04417894</url>
  </required_header>
  <id_info>
    <org_study_id>R668-AD-1924</org_study_id>
    <secondary_id>2019-003088-22</secondary_id>
    <nct_id>NCT04417894</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</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>
      The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in&#xD;
      patients with atopic hand and foot dermatitis.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep&#xD;
           loss, health related QoL, work life impairment) in patients with atopic hand and foot&#xD;
           dermatitis&#xD;
&#xD;
        -  To evaluate the safety and tolerability of dupilumab administered to patients with&#xD;
           atopic hand and foot dermatitis&#xD;
&#xD;
        -  To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic&#xD;
           hand and foot dermatitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2021</start_date>
  <completion_date type="Actual">November 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>Phase 3</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>Proportion of patients achieving an Investigator Global Assessment (IGA) (hand and foot) score of 0 or 1</measure>
    <time_frame>At week 16</time_frame>
    <description>IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (NRS) ≥4</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in weekly average of daily hand and foot peak Pruritus NRS</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in Modified Total Lesion Sign Score (mTLSS) for hand/foot lesions</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in weekly average of daily hand and foot peak Pain NRS</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Pain NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in weekly average of daily Sleep NRS</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent surface area of hand and foot involvement with AD</measure>
    <time_frame>Baseline to week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in weekly average of daily hand and foot peak Pruritus NRS</measure>
    <time_frame>Baseline to week 4</time_frame>
    <description>Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4</measure>
    <time_frame>Baseline to week 4</time_frame>
    <description>Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in Hand Eczema Severity Index (HECSI) score</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>For patients with hand dermatitis&#xD;
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HECSI-75</measure>
    <time_frame>At week 16</time_frame>
    <description>For patients with hand dermatitis&#xD;
HECSI-75 is defined as HECSI score has ≥75% improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HECSI-50</measure>
    <time_frame>At week 16</time_frame>
    <description>For patients with hand dermatitis&#xD;
HECSI-50 is defined as HECSI score has ≥50% improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HECSI-90</measure>
    <time_frame>At week 16</time_frame>
    <description>For patients with hand dermatitis&#xD;
HECSI-90 is defined as HECSI score has ≥90% improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>For patients with hand dermatitis&#xD;
QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Work Productivity and Impairment (WPAI) + Classroom Impairment Questionnaire (CIQ)</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Through week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough concentration of functional dupilumab in serum</measure>
    <time_frame>Up to week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent anti-drug antibody (ADA) and titer</measure>
    <time_frame>Up to week 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Moderate to Severe Atopic Hand and Foot Dermatitis</condition>
  <arm_group>
    <arm_group_label>dupilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered SC Q2W, following a loading dose on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dupilumab</intervention_name>
    <description>Solution for subcutaneous (SC) injection administration</description>
    <arm_group_label>dupilumab</arm_group_label>
    <other_name>DUPIXENT®</other_name>
    <other_name>REGN668</other_name>
    <other_name>SAR231893</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Solution for SC injection administration</description>
    <arm_group_label>Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Patients with involvement of at least 2 anatomical areas at screening and baseline&#xD;
&#xD;
          -  Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe&#xD;
             disease) at screening and baseline&#xD;
&#xD;
          -  Patients with documented recent history (within 6 months before the screening visit)&#xD;
             of inadequate response of atopic hand and foot dermatitis to topical medication(s)&#xD;
&#xD;
          -  Patients meet the diagnosis criteria for atopic dermatitis (AD)&#xD;
&#xD;
          -  Provide informed consent/assent signed by study patient or legally acceptable&#xD;
             representative&#xD;
&#xD;
          -  Patients need to have been compliant with the skin protection measures through the&#xD;
             entire duration of the screening period&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with dupilumab in the past&#xD;
&#xD;
          -  Patients with a positive patch test reaction that are deemed to be clinically relevant&#xD;
             as the current cause of the hand and foot dermatitis&#xD;
&#xD;
          -  Patients with documented exposure to irritants believed to be a predominant cause of&#xD;
             the current hand and foot dermatitis&#xD;
&#xD;
          -  Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs&#xD;
             within 4 weeks prior to baseline&#xD;
&#xD;
          -  Known history of HIV/HBV/HCV infection&#xD;
&#xD;
          -  Pregnant or breastfeeding women or planning to become pregnant or breastfeed during&#xD;
             the patient's participation in this study&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) who are unwilling to practice highly effective&#xD;
             contraception prior to the initial dose/start of the first treatment and during the&#xD;
             study&#xD;
&#xD;
        NOTE: Other protocol defined inclusion / exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Indiana</state>
        <zip>47201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kew Gardens</city>
        <state>New York</state>
        <zip>11415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Langenau</city>
        <state>Baden Wurttemberg</state>
        <zip>89129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Augsburg</city>
        <zip>86179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mahlow</city>
        <zip>15831</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>211-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>593-8324</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <zip>169-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tachikawa</city>
        <state>Tokyo</state>
        <zip>190-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Osaka</city>
        <zip>532-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tokyo</city>
        <zip>143-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-453</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chorzow</city>
        <zip>41-516</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-648</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-851</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Kielce</city>
        <zip>25-155</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ostrowiec Swietokrzyski</city>
        <zip>27-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-142</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-692</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-953</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-381</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</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</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>August 28, 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/NCT04417894
org study id: R668-AD-1924
secondary id: 2019-003088-22
nct id: NCT04417894
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in
      patients with atopic hand and foot dermatitis.

      The secondary objectives of the study are:

        -  To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep
           loss, health related QoL, work life impairment) in patients with atopic hand and foot
           dermatitis

        -  To evaluate the safety and tolerability of dupilumab administered to patients with
           atopic hand and foot dermatitis

        -  To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic
           hand and foot dermatitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of patients achieving an Investigator Global Assessment (IGA) (hand and foot) score of 0 or 1
time frame: At week 16
description: IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.
measure: Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus Numerical Rating Scale (NRS) ≥4
time frame: Baseline to week 16
description: Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
measure: Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥3
time frame: Baseline to week 16
description: Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
measure: Percent change in weekly average of daily hand and foot peak Pruritus NRS
time frame: Baseline to week 16
description: Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
measure: Percent change in Modified Total Lesion Sign Score (mTLSS) for hand/foot lesions
time frame: Baseline to week 16
description: mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
measure: Percent change in weekly average of daily hand and foot peak Pain NRS
time frame: Baseline to week 16
description: Pain NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
measure: Percent change in weekly average of daily Sleep NRS
time frame: Baseline to week 16
description: Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
measure: Change in percent surface area of hand and foot involvement with AD
time frame: Baseline to week 16
measure: Percent change in weekly average of daily hand and foot peak Pruritus NRS
time frame: Baseline to week 4
description: Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
measure: Proportion of patients with improvement (reduction) of weekly average of daily hand and foot peak Pruritus NRS ≥4
time frame: Baseline to week 4
description: Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
measure: Percent change in Hand Eczema Severity Index (HECSI) score
time frame: Baseline to week 16
description: For patients with hand dermatitis
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).
measure: Proportion of patients with HECSI-75
time frame: At week 16
description: For patients with hand dermatitis
HECSI-75 is defined as HECSI score has ≥75% improvement from baseline.
measure: Proportion of patients with HECSI-50
time frame: At week 16
description: For patients with hand dermatitis
HECSI-50 is defined as HECSI score has ≥50% improvement from baseline.
measure: Proportion of patients with HECSI-90
time frame: At week 16
description: For patients with hand dermatitis
HECSI-90 is defined as HECSI score has ≥90% improvement from baseline.
measure: Change in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
time frame: Baseline to week 16
description: For patients with hand dermatitis
QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.
measure: Change in Work Productivity and Impairment (WPAI) + Classroom Impairment Questionnaire (CIQ)
time frame: Baseline to week 16
description: WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.
measure: Incidence of treatment-emergent adverse events (TEAEs)
time frame: Through week 16
measure: Trough concentration of functional dupilumab in serum
time frame: Up to week 28
measure: Incidence of treatment-emergent anti-drug antibody (ADA) and titer
time frame: Up to week 28
arm group label: dupilumab
arm group type: Experimental
description: Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
arm group label: Matching Placebo
arm group type: Experimental
description: Administered SC Q2W, following a loading dose on Day 1
intervention type: Drug
intervention name: dupilumab
description: Solution for subcutaneous (SC) injection administration
arm group label: dupilumab
other name: DUPIXENT®
other name: REGN668
other name: SAR231893
intervention type: Drug
intervention name: Placebo
description: Solution for SC injection administration
arm group label: Matching Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Japan
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/
submitted: August 28, 2023