<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/NCT03826901</url>
  </required_header>
  <id_info>
    <org_study_id>LP0133-1181</org_study_id>
    <nct_id>NCT03826901</nct_id>
  </id_info>
  <brief_title>Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children</brief_title>
  <official_title>A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</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>
      This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical&#xD;
      delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years&#xD;
      and above) with atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and&#xD;
      pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream&#xD;
      for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>Week 0 to Week 8</time_frame>
    <description>Number of AEs and number of subjects with AEs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameter - Cmax</measure>
    <time_frame>at Day 8</time_frame>
    <description>Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameter - AUC</measure>
    <time_frame>at Day 8</time_frame>
    <description>AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameter - tmax</measure>
    <time_frame>at Day 8</time_frame>
    <description>tmax</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Part 1: adults and adolescents (12 years and above)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Delgocitinib cream (dosage: A mg/g).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: children (2-11 years)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Delgocitinib cream (dosage: B mg/g).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>delgocitinib</intervention_name>
    <description>Cream for topical application</description>
    <arm_group_label>Part 1: adults and adolescents (12 years and above)</arm_group_label>
    <arm_group_label>Part 2: children (2-11 years)</arm_group_label>
    <other_name>LEO 124249</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion criteria (Part 1: adults and adolescents; 12 years and above)&#xD;
&#xD;
          -  Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980)&#xD;
             criteria for AD&#xD;
&#xD;
          -  Age 12 years and above at baseline&#xD;
&#xD;
          -  AD involvement of 25-50% treatable body surface area (BSA) at screening and at&#xD;
             baseline&#xD;
&#xD;
          -  Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic&#xD;
             Dermatitis [vIGA-AD] score of at least 3) at screening and at baseline&#xD;
&#xD;
        Key Inclusion criteria (Part 2: children; 2-11 years)&#xD;
&#xD;
          -  Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD&#xD;
&#xD;
          -  Age 2-11 years at baseline&#xD;
&#xD;
          -  History of AD for at least 3 months (children aged 2-5 years), and at least 12 months&#xD;
             (children aged 6-11 years)&#xD;
&#xD;
          -  AD involvement of ≥35% treatable BSA at screening and at baseline&#xD;
&#xD;
          -  Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline&#xD;
&#xD;
        Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above)&#xD;
&#xD;
          -  Active dermatologic conditions that may interfere with the diagnosis of AD&#xD;
&#xD;
          -  Use of tanning beds or phototherapy within 4 weeks prior to baseline&#xD;
&#xD;
          -  Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4&#xD;
             weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to&#xD;
             baseline&#xD;
&#xD;
          -  Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs),&#xD;
             topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline&#xD;
&#xD;
          -  Clinically significant infection (systemic infection or serious skin infection&#xD;
             requiring parenteral treatment) within 4 weeks prior to baseline&#xD;
&#xD;
          -  Any disorder, which is not stable, and in the investigator's opinion could affect the&#xD;
             safety of the subject, influence the results of the trial or impede the subject's&#xD;
             ability to complete the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>LEO Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Red Deer</city>
        <state>Alberta</state>
        <zip>46-37535</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEO Pharma investigational site</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2K 4L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adults, pediatric</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>Yes</sharing_ipd>
    <ipd_description>De-identified IPD can be made available to researchers in a closed environment for a specified period of time.&#xD;
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data is available to request after approval of the studied indication.</ipd_time_frame>
    <ipd_url>http://leopharmatrials.com/for-professionals</ipd_url>
  </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/NCT03826901
org study id: LP0133-1181
nct id: NCT03826901
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical
      delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years
      and above) with atopic dermatitis.
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and
      pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream
      for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events (AEs)
time frame: Week 0 to Week 8
description: Number of AEs and number of subjects with AEs
measure: PK parameter - Cmax
time frame: at Day 8
description: Cmax
measure: PK parameter - AUC
time frame: at Day 8
description: AUC
measure: PK parameter - tmax
time frame: at Day 8
description: tmax
arm group label: Part 1: adults and adolescents (12 years and above)
arm group type: Experimental
description: Delgocitinib cream (dosage: A mg/g).
arm group label: Part 2: children (2-11 years)
arm group type: Experimental
description: Delgocitinib cream (dosage: B mg/g).
intervention type: Drug
intervention name: delgocitinib
description: Cream for topical application
arm group label: Part 1: adults and adolescents (12 years and above)
arm group label: Part 2: children (2-11 years)
other name: LEO 124249
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Expert
role: Study Director
affiliation: LEO Pharma
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data is available to request after approval of the studied indication.
ipd url: http://leopharmatrials.com/for-professionals