<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/NCT03257644</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 18424-102</org_study_id>
    <nct_id>NCT03257644</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis</brief_title>
  <official_title>An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</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 purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics&#xD;
      (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with&#xD;
      atopic dermatitis (AD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four&#xD;
      additional cohorts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">October 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants with treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Screening through 30-37 days after end of treatment, up to approximately 12 weeks.</time_frame>
    <description>A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first application of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of ruxolitinib for Cohorts 1 and 2</measure>
    <time_frame>Day 1, Day 15, and Day 29</time_frame>
    <description>Venous blood samples will be collected to assess the PK of ruxolitinib .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6</measure>
    <time_frame>Day 1, Day 10, and Day 29</time_frame>
    <description>Venous blood samples will be collected to assess the PK of ruxolitinib .</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 0.5%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 1.5%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 0.75%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 1.5%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 0.75%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib phosphate cream 1.5%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib phosphate cream</intervention_name>
    <description>Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_label>Cohort 6</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric subjects aged ≥ 2 to 17 years, inclusive&#xD;
&#xD;
          -  Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.&#xD;
&#xD;
          -  Subjects with active inflammation associated with AD.&#xD;
&#xD;
          -  Subjects with an Investigator's Global Assessment (IGA) score of at least 2 at&#xD;
             screening and baseline.&#xD;
&#xD;
          -  Subjects with body surface area (BSA) of AD involvement of 8% to 20% at screening and&#xD;
             baseline.&#xD;
&#xD;
          -  Subjects who agree to discontinue all agents used to treat AD from screening through&#xD;
             the final follow-up visit.&#xD;
&#xD;
          -  Subjects of childbearing potential must agree to take appropriate precautions to avoid&#xD;
             pregnancy or fathering a child for the duration of study participation.&#xD;
&#xD;
          -  Written informed consent of the parent(s) or legal guardian and a verbal or written&#xD;
             assent from the subject when possible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined&#xD;
             by the investigator over the previous 4 weeks before baseline.&#xD;
&#xD;
          -  Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream)&#xD;
             within 2 weeks of baseline.&#xD;
&#xD;
          -  Concurrent conditions and history of other diseases:&#xD;
&#xD;
               -  Presence of AD lesions only on the hands or feet without a history of involvement&#xD;
                  of other classical areas of involvement such as the face or the flexural folds.&#xD;
&#xD;
               -  Other types of eczema.&#xD;
&#xD;
               -  Any other concomitant skin disorder (eg, generalized erythroderma such as&#xD;
                  Netherton Syndrome, or psoriasis), pigmentation, or extensive scarring that in&#xD;
                  the opinion of the investigator may interfere with the evaluation of AD lesions&#xD;
                  or compromise subject safety.&#xD;
&#xD;
               -  Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,&#xD;
                  Wiskott-Aldrich syndrome) or have a history of malignant disease within 5 years&#xD;
                  before the baseline visit.&#xD;
&#xD;
               -  Chronic or acute infection requiring treatment with systemic antibiotics,&#xD;
                  antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before&#xD;
                  the baseline visit.&#xD;
&#xD;
               -  Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster,&#xD;
                  chicken pox) skin infection within 1 week before the baseline visit.&#xD;
&#xD;
               -  Chronic asthma requiring more than 880 μg of inhaled budesonide or equivalent&#xD;
                  high dose of other inhaled corticosteroids.&#xD;
&#xD;
          -  Subjects with cytopenias at screening per protocol-defined criteria.&#xD;
&#xD;
          -  Use of the following medications:&#xD;
&#xD;
               -  Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable&#xD;
                  corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine)&#xD;
                  within 4 weeks or 5 half-lives of baseline (whichever is longer).&#xD;
&#xD;
               -  Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole&#xD;
                  within 2 weeks or 5 half lives, whichever is longer, before the baseline visit&#xD;
                  (topical agents with limited systemic availability are permitted).&#xD;
&#xD;
               -  Subjects who have previously received JAK inhibitors, systemic or topical (eg,&#xD;
                  ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).&#xD;
&#xD;
               -  Current treatment or treatment within 30 days or 5 half-lives (whichever is&#xD;
                  longer) before the baseline visit with another investigational medication or&#xD;
                  current enrollment in another investigational drug protocol.&#xD;
&#xD;
               -  Use of any prohibited medications within 14 days or 5 half-lives (whichever is&#xD;
                  longer) of the baseline visit.&#xD;
&#xD;
          -  Parent or legal guardian who, in the opinion of the investigator, is unable or&#xD;
             unlikely to comply with the administration schedule and study evaluations or are&#xD;
             unable or unwilling to apply the study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Kuligowski, MD, PhD, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cahaba Dermatology</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Sky Dermatology</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Applied Research Center of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children'S Hospital Los Angeles Specialt</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children'S Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acevedo Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Floridian Research Institute Llc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rm Medical Research Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iact Health</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indiana Clincal Trials Center</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Fivenson, Md, Pllc</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates Llc</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3Rgy Research - Clinedge - Ppds</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Dermatology and Laser Specialists</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>Janus kinase (JAK) inhibitor</keyword>
  <keyword>pediatric</keyword>
  <keyword>inflammation</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/NCT03257644
org study id: INCB 18424-102
nct id: NCT03257644
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics
      (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with
      atopic dermatitis (AD).
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four
      additional cohorts.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants with treatment-emergent adverse events (TEAEs)
time frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
description: A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first application of study drug.
measure: Plasma concentrations of ruxolitinib for Cohorts 1 and 2
time frame: Day 1, Day 15, and Day 29
description: Venous blood samples will be collected to assess the PK of ruxolitinib .
measure: Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
time frame: Day 1, Day 10, and Day 29
description: Venous blood samples will be collected to assess the PK of ruxolitinib .
arm group label: Cohort 1
arm group type: Experimental
description: Ruxolitinib phosphate cream 0.5%.
arm group label: Cohort 2
arm group type: Experimental
description: Ruxolitinib phosphate cream 1.5%.
arm group label: Cohort 3
arm group type: Experimental
description: Ruxolitinib phosphate cream 0.75%.
arm group label: Cohort 4
arm group type: Experimental
description: Ruxolitinib phosphate cream 1.5%.
arm group label: Cohort 5
arm group type: Experimental
description: Ruxolitinib phosphate cream 0.75%.
arm group label: Cohort 6
arm group type: Experimental
description: Ruxolitinib phosphate cream 1.5%.
intervention type: Drug
intervention name: Ruxolitinib phosphate cream
description: Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
arm group label: Cohort 6
other name: INCB018424
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Michael Kuligowski, MD, PhD, MBA
role: Study Director
affiliation: Incyte Corporation
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country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No