<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/NCT03750643</url>
  </required_header>
  <id_info>
    <org_study_id>17090</org_study_id>
    <secondary_id>J1B-MC-FRCC</secondary_id>
    <nct_id>NCT03750643</nct_id>
  </id_info>
  <brief_title>A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis</brief_title>
  <official_title>Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</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 main purpose of this study is to investigate the safety, tolerability, and efficacy of&#xD;
      the study drug known as LY3454738 in healthy participants and participants with atopic&#xD;
      dermatitis. The study has three parts. Each participant will enroll in one part. The study&#xD;
      will last 12 to 24 weeks, depending on part.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">September 7, 2021</completion_date>
  <primary_completion_date type="Actual">September 7, 2021</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline</measure>
    <time_frame>Week 12</time_frame>
    <description>The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Drug Concentration (Cmax) of LY3454738</measure>
    <time_frame>Day 1 through Day 85 (Day 99 for Part C)</time_frame>
    <description>Cmax of LY3454738</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738</measure>
    <time_frame>Day 1 through Day 85 (Day 99 for Part C)</time_frame>
    <description>AUC of LY3454738</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>LY3454738 - Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Part A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered IV to healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3454738 - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3454738 administered IV to healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Part B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered IV to healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3454738 - Part C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3454738 administered IV to participants with atopic dermatitis (AD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Part C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered IV to participants with AD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3454738</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>LY3454738 - Part A</arm_group_label>
    <arm_group_label>LY3454738 - Part B</arm_group_label>
    <arm_group_label>LY3454738 - Part C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3454738</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY3454738 - Part A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Placebo - Part A</arm_group_label>
    <arm_group_label>Placebo - Part B</arm_group_label>
    <arm_group_label>Placebo - Part C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All: Must have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²),&#xD;
             inclusive, for Parts A and B, and 18.0 to 45.0 kg/m², inclusive, for Part C and a&#xD;
             minimum body weight of 50 kilograms&#xD;
&#xD;
          -  For PART A and B only, regarding the inclusion of healthy Japanese participants:&#xD;
             Minimum age is 20 years and the participant's biological parents and all of the&#xD;
             participant's biological grandparents must be of exclusive Japanese descent and must&#xD;
             have been born in Japan&#xD;
&#xD;
          -  AD:&#xD;
&#xD;
               -  Must have a diagnosis of AD for at least 12 months with either poor response to&#xD;
                  topical treatments or inability to use topical treatments&#xD;
&#xD;
               -  Must agree to use moisturizer daily throughout the treatment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All: must not have previously completed a clinical trial with a molecule targeting&#xD;
             interleukin-33 (IL-33) or its receptor&#xD;
&#xD;
          -  AD:&#xD;
&#xD;
               -  Must not have received certain topical medications for AD within 2 weeks prior to&#xD;
                  randomization&#xD;
&#xD;
               -  Must not have received certain oral medications for AD or received phototherapy&#xD;
                  within 4 weeks prior to randomization&#xD;
&#xD;
               -  Must not have received any antibody-based biologic agents (marketed or&#xD;
                  investigational) within 5 half lives (t1/2) of the drug prior to randomization&#xD;
&#xD;
               -  Must not have received intravenous, intramuscular, or intra-articular steroids in&#xD;
                  the past 6 weeks prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Research Trials, LLC</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Arkansas Clinical Trials Center</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First OC Dermatology</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Clinical Trials Medical Group</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revival Research Corporation</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Health Research Center</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ForCare Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613-1244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Sciences, PLLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAREXEL-Phase 1 Baltimore Harbor Hospital Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Clinical Research Center</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JUVA Skin &amp; Laser Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022-3350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wright State Physicians Dermatology</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>46435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Sooner Research</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</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>Premier Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology</name>
      <address>
        <city>Los Prados</city>
        <zip>00727</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group, PSC - Hato Rey Site</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Poland</country>
  </removed_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/1FiRtIYceUkw4QOKAMusai</url>
    <description>A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)</description>
  </link>
  <verification_date>October 1, 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</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>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/NCT03750643
org study id: 17090
secondary id: J1B-MC-FRCC
nct id: NCT03750643
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to investigate the safety, tolerability, and efficacy of
      the study drug known as LY3454738 in healthy participants and participants with atopic
      dermatitis. The study has three parts. Each participant will enroll in one part. The study
      will last 12 to 24 weeks, depending on part.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
time frame: Baseline up to Week 24
description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
measure: Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline
time frame: Week 12
description: The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification
measure: Maximum Observed Drug Concentration (Cmax) of LY3454738
time frame: Day 1 through Day 85 (Day 99 for Part C)
description: Cmax of LY3454738
measure: Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
time frame: Day 1 through Day 85 (Day 99 for Part C)
description: AUC of LY3454738
arm group label: LY3454738 - Part A
arm group type: Experimental
description: Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
arm group label: Placebo - Part A
arm group type: Placebo Comparator
description: Placebo administered IV to healthy participants
arm group label: LY3454738 - Part B
arm group type: Experimental
description: LY3454738 administered IV to healthy participants
arm group label: Placebo - Part B
arm group type: Placebo Comparator
description: Placebo administered IV to healthy participants
arm group label: LY3454738 - Part C
arm group type: Experimental
description: LY3454738 administered IV to participants with atopic dermatitis (AD)
arm group label: Placebo - Part C
arm group type: Placebo Comparator
description: Placebo administered IV to participants with AD
intervention type: Drug
intervention name: LY3454738
description: Administered IV
arm group label: LY3454738 - Part A
arm group label: LY3454738 - Part B
arm group label: LY3454738 - Part C
intervention type: Drug
intervention name: LY3454738
description: Administered SC
arm group label: LY3454738 - Part A
intervention type: Drug
intervention name: Placebo
description: Administered IV
arm group label: Placebo - Part A
arm group label: Placebo - Part B
arm group label: Placebo - Part C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Puerto Rico
country: United States
country: Bulgaria
country: Poland
url: https://trials.lillytrialguide.com/en-US/trial/1FiRtIYceUkw4QOKAMusai
description: A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: No