<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/NCT04440410</url>
  </required_header>
  <id_info>
    <org_study_id>YDC-2</org_study_id>
    <nct_id>NCT04440410</nct_id>
  </id_info>
  <brief_title>Evaluation of Cutaneous and Circulating Inflammatory Biomarkers in Hidradenitis Suppurativa and Atopic Dermatitis</brief_title>
  <official_title>Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kymera Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>York Dermatology Clinic and Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kymera Therapeutics, Inc.</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 non-intervention study will identify the biomarker profiles in hidradenitis suppurativa&#xD;
      (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in&#xD;
      interventional studies evaluating efficacy during therapeutic intervention. Study data will&#xD;
      also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue,&#xD;
      with clinical/histopathological phenotypes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an exploratory correlative study in subjects with HS or AD. Blood samples and&#xD;
      skin biopsies will be collected from all subjects and used to assess the following: cutaneous&#xD;
      and circulating inflammatory biomarkers and IRAK4 target levels in primary samples,&#xD;
      correlations between cutaneous and circulating inflammatory biomarkers and disease severity,&#xD;
      effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex&#xD;
      vivo-treated whole blood from patients.&#xD;
&#xD;
      De-identified routine clinical data that is collected will be correlated with the research&#xD;
      findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">March 24, 2021</completion_date>
  <primary_completion_date type="Actual">March 24, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarker Identification</measure>
    <time_frame>Day 1</time_frame>
    <description>Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of Biomarker Correlations</measure>
    <time_frame>Day 1</time_frame>
    <description>Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examination of IRAK4 Degradation Effects Ex Vivo</measure>
    <time_frame>Day 1</time_frame>
    <description>Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>Hidradenitis suppurativa</arm_group_label>
    <description>Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atopic Dermatitis</arm_group_label>
    <description>Subjects with active moderate or severe AD disease using the PGA assessment</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples, skin biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. Active HS or AD disease, diagnosed by PI&#xD;
&#xD;
          3. Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA&#xD;
             assessment.&#xD;
&#xD;
          4. Must sign an informed consent form (ICF) indicating that he or she understands the&#xD;
             purpose of and procedures required for the study, and is willing to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is currently on a biologic or other immunosuppressive treatment for HS or AD.&#xD;
&#xD;
          2. Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is&#xD;
             longer&#xD;
&#xD;
          3. Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.&#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>Afsaneh Alavi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>York Dermatology Clinic and Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>York Dermatology Clinic and Research Centre</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>L4C 9M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IRAK4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Hidradenitis</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/NCT04440410
org study id: YDC-2
nct id: NCT04440410
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa
      (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in
      interventional studies evaluating efficacy during therapeutic intervention. Study data will
      also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue,
      with clinical/histopathological phenotypes.
This study is an exploratory correlative study in subjects with HS or AD. Blood samples and
      skin biopsies will be collected from all subjects and used to assess the following: cutaneous
      and circulating inflammatory biomarkers and IRAK4 target levels in primary samples,
      correlations between cutaneous and circulating inflammatory biomarkers and disease severity,
      effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex
      vivo-treated whole blood from patients.

      De-identified routine clinical data that is collected will be correlated with the research
      findings.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Biomarker Identification
time frame: Day 1
description: Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples
measure: Determination of Biomarker Correlations
time frame: Day 1
description: Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity
measure: Examination of IRAK4 Degradation Effects Ex Vivo
time frame: Day 1
description: Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients
arm group label: Hidradenitis suppurativa
description: Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment
arm group label: Atopic Dermatitis
description: Subjects with active moderate or severe AD disease using the PGA assessment
Blood samples, skin biopsies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Afsaneh Alavi, MD
role: Principal Investigator
affiliation: York Dermatology Clinic and Research Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Hidradenitis
sharing ipd: No