xml: <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/NCT05983068</url>
    </required_header>
    <id_info>
      <org_study_id>LPS17764</org_study_id>
      <secondary_id>U1111-1280-5813</secondary_id>
      <nct_id>NCT05983068</nct_id>
    </id_info>
    <brief_title>A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis</brief_title>
    <acronym>PELISTAD-EX2</acronym>
    <official_title>A Two-year, Phase 4, Open-label, Single-arm Treatment Study to Evaluate the Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants (≥6 to &lt;14 Years of Age) With Moderate-to-severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Regeneron Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanofi</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week&#xD;
        treatment phase designed to investigate dupilumab's long-term effect on skin barrier function&#xD;
        as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in&#xD;
        approximately 48 pediatric participants (aged ≥6 and &lt;14 years at study entry) with&#xD;
        moderate-to-severe AD. After the 104-week treatment phase and the last assessment at the&#xD;
        EndofTreatment (EOT) visit (as planned at Week 104), participants will be followed-up for 4&#xD;
        weeks and an End-of-Study (EoS) by telephone at 4 weeks after the EOT visit will end the&#xD;
        study for each participant. The maximum duration of the study per participant will be 112&#xD;
        weeks (including screening period).&#xD;
  &#xD;
        TEWL assessment in predefined lesional and non-lesional skin areas before and after STS will&#xD;
        be conducted every 3 months (every 13 weeks) during the treatment period from Day 1&#xD;
        (Baseline/Week 0, Visit 2) to Week 104 (Visit 10/EoT).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study duration for each participant will be approximately 112 weeks, including:&#xD;
  &#xD;
          -  Screening period: Up to 4 weeks (Day -28 to Day -1) from signing the informed consent.&#xD;
  &#xD;
          -  Open-label dupilumab treatment period: 104 weeks (from Day 1/Week 0 to Week 104).&#xD;
  &#xD;
          -  Follow-up period: 4 weeks (safety follow-up phone visit at 4 weeks after the EoT visit).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">June 3, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 22, 2026</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>Percent change from baseline in TEWL after 5 STS assessed on lesional skin.</measure>
      <time_frame>Baseline to Week 104</time_frame>
      <description>Percent change from baseline in TEWL after 5 STS assessed on lesional skin.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.</measure>
      <time_frame>Baseline to Week 104</time_frame>
      <description>Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS, respectively, assessed on lesional skin at each study visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the study.</measure>
      <time_frame>Baseline to Week 108</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Dermatitis Atopic</condition>
    <arm_group>
      <arm_group_label>Pediatric AD participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>dupilumab</intervention_name>
      <description>solution for injection; by subcutaneous (SC) injection</description>
      <arm_group_label>Pediatric AD participants</arm_group_label>
      <other_name>REGN668</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age&#xD;
  &#xD;
            -  For new participants: ≥6 to &lt;12 years of age (inclusive), at the time of signing the&#xD;
               informed consent.&#xD;
  &#xD;
            -  For former PELISTAD participants: ≥6 to &lt;14 years of age at the time of signing the&#xD;
               informed consent.&#xD;
  &#xD;
          Type of participant and disease characteristics&#xD;
  &#xD;
            -  With AD diagnosis according to Hanifin and Rajka criteria at least 1 year before&#xD;
               screening.&#xD;
  &#xD;
            -  Applicable to new participants only: Investigator Global Assessment score of ≥3 (for&#xD;
               US participants) or IGA ≥4 (for EU participants) at screening (on the 0 to 4 scale)&#xD;
               depending on approved IGA label indication in the country.&#xD;
  &#xD;
            -  Applicable to new participants only: Have active lesions on the upper limbs or lower&#xD;
               limbs (including trunk, if needed), with severity for lesion erythema or&#xD;
               edema/papulation ≥2 at screening on the 0 to 3 scale of the ISS.&#xD;
  &#xD;
            -  Applicable to new participants only: Should have a non-lesional (normal looking) skin&#xD;
               area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin&#xD;
               4 cm from the lesional area, it is acceptable to identify normal looking skin as close&#xD;
               to the lesion as possible.&#xD;
  &#xD;
            -  Willing to refrain from applying any topical medications on the target assessment&#xD;
               areas (including lesional and non-lesional) throughout the study until EoS unless&#xD;
               necessary to alleviate intolerable symptoms.&#xD;
  &#xD;
            -  Willing and able to comply with all clinic visits and study-related procedures. Weight&#xD;
               -Body weight ≥15 kg at screening. - - -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Medical conditions&#xD;
  &#xD;
            -  Skin conditions other than AD that can confound assessments in the area of TEWL&#xD;
               assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea&#xD;
               infection, contact dermatitis).&#xD;
  &#xD;
            -  Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment&#xD;
               area leaving insufficient skin that is adequate for TEWL assessments.&#xD;
  &#xD;
            -  Hypersensitivity to the active substance or to any of the excipients of dupilumab.&#xD;
  &#xD;
            -  Ocular disorder that in the opinion of the Investigator could adversely affect the&#xD;
               individual's risk for study participation.&#xD;
  &#xD;
            -  Severe concomitant illness(es) that, in the Investigator's judgment, would adversely&#xD;
               affect the participant's participation in the study.&#xD;
  &#xD;
            -  History of hypersensitivity reaction to skin tape or adhesives used in desquamme&#xD;
               discs.&#xD;
  &#xD;
          Prior/concomitant therapy&#xD;
  &#xD;
            -  Treatment with any investigational medication other than dupilumab within 16 weeks or&#xD;
               within 5 half-lives (if known) prior to Day 1, whichever is longer.&#xD;
  &#xD;
            -  Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine&#xD;
               (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK)&#xD;
               inhibitors or phototherapy within 4 weeks of baseline.&#xD;
  &#xD;
            -  Topical AD treatment within 1 week of baseline. Face and neck may be treated with&#xD;
               topical steroids during the washout period if approved by the Investigator.&#xD;
  &#xD;
            -  Participants who received a live vaccine within 4 weeks of baseline. Prior/concurrent&#xD;
               clinical study experience&#xD;
  &#xD;
            -  Current participation in another investigational or interventional clinical study.&#xD;
  &#xD;
          The above information is not intended to contain all considerations relevant to a potential&#xD;
          participation in a clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Sciences &amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>6#</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983068
  org study id: LPS17764
  secondary id: U1111-1280-5813
  nct id: NCT05983068
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week
        treatment phase designed to investigate dupilumab's long-term effect on skin barrier function
        as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in
        approximately 48 pediatric participants (aged ≥6 and <14 years at study entry) with
        moderate-to-severe AD. After the 104-week treatment phase and the last assessment at the
        EndofTreatment (EOT) visit (as planned at Week 104), participants will be followed-up for 4
        weeks and an End-of-Study (EoS) by telephone at 4 weeks after the EOT visit will end the
        study for each participant. The maximum duration of the study per participant will be 112
        weeks (including screening period).
  
        TEWL assessment in predefined lesional and non-lesional skin areas before and after STS will
        be conducted every 3 months (every 13 weeks) during the treatment period from Day 1
        (Baseline/Week 0, Visit 2) to Week 104 (Visit 10/EoT).
  Study duration for each participant will be approximately 112 weeks, including:
  
          -  Screening period: Up to 4 weeks (Day -28 to Day -1) from signing the informed consent.
  
          -  Open-label dupilumab treatment period: 104 weeks (from Day 1/Week 0 to Week 104).
  
          -  Follow-up period: 4 weeks (safety follow-up phone visit at 4 weeks after the EoT visit).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
  time frame: Baseline to Week 104
  description: Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
  measure: Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.
  time frame: Baseline to Week 104
  description: Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS, respectively, assessed on lesional skin at each study visit
  measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the study.
  time frame: Baseline to Week 108
  arm group label: Pediatric AD participants
  arm group type: Experimental
  description: Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.
  intervention type: Drug
  intervention name: dupilumab
  description: solution for injection; by subcutaneous (SC) injection
  arm group label: Pediatric AD participants
  other name: REGN668
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 13 Years
  healthy volunteers: No
  last name: Clinical Sciences & Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial Transparency email recommended (Toll free number for US & Canada)
  phone: 800-633-1610
  phone ext: 6#
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org