<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/NCT03754309</url>
  </required_header>
  <id_info>
    <org_study_id>KY1005-CT02</org_study_id>
    <secondary_id>2018-002299-41</secondary_id>
    <secondary_id>ACT17369</secondary_id>
    <nct_id>NCT03754309</nct_id>
  </id_info>
  <brief_title>A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis</brief_title>
  <official_title>A Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kymab Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kymab Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to investigate if KY1005 results in improvement of&#xD;
      eczema when given to participants with moderate to severe disease. Side effects of KY1005&#xD;
      will also be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy,&#xD;
      safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic&#xD;
      dermatitis whose disease cannot be adequately controlled with topical medications or for whom&#xD;
      topical treatment is medically inadvisable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">October 8, 2020</completion_date>
  <primary_completion_date type="Actual">May 12, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage change in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage and absolute change from Baseline in EASI over time</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in epidermal thickness</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in keratin 16 staining of skin biopsies</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least a 50% reduction in EASI (EASI 50)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least a 75% reduction in EASI (EASI 75)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least a 90% reduction in EASI (EASI 90)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Validated Investigator Global Assessment (vIGA)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a response of vIGA 0 or 1</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SCORing of Atopic Dermatis (SCORAD) Index</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in affected body surface area (BSA)</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Orientated Eczema Measure (POEM)</measure>
    <time_frame>Baseline to Day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dermatology Quality of Life Index (DLQI)</measure>
    <time_frame>Baseline to Day 113</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Numerical Rating Scale (NRS) for pruritus</measure>
    <time_frame>Baseline to day 113</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>KY1005 lower dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose KY1005</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KY1005 higher dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose KY1005</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KY1005</intervention_name>
    <description>A human anti-OX40 ligand monoclonal antibody</description>
    <arm_group_label>KY1005 higher dose</arm_group_label>
    <arm_group_label>KY1005 lower dose</arm_group_label>
    <other_name>SAR445229</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (greater than or equal to [&gt;=] 18 years but less than [&lt;] 75 years of age) with&#xD;
             Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first&#xD;
             administration of Investigational Medicinal Product [IMP]).&#xD;
&#xD;
          -  Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or&#xD;
             higher at Baseline.&#xD;
&#xD;
          -  validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.&#xD;
&#xD;
          -  AD involvement of 10 percent or more of body surface area at Baseline.&#xD;
&#xD;
          -  Documented history, within 6 months prior to Baseline, of either inadequate response&#xD;
             to topical treatments or inadvisability of topical treatments.&#xD;
&#xD;
          -  Must have applied a stable dose of topical bland emollient (simple moisturizer, no&#xD;
             additives [e.g., urea]) at least twice daily for at least 7 consecutive days before&#xD;
             Baseline.&#xD;
&#xD;
          -  Able and willing to comply with requested study visits/telephone visits and&#xD;
             procedures.&#xD;
&#xD;
          -  Able and willing to provide punch biopsy of both lesional and non-lesional skin at&#xD;
             Baseline.&#xD;
&#xD;
          -  Able and willing to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent treatment within specific time windows before the baseline visit for the&#xD;
             management of atopic dermatitis such as topical or systemic corticosteroids, biologic&#xD;
             or investigational therapies and/or phototherapy.&#xD;
&#xD;
          -  Known history of or suspected significant current immunosuppression, including history&#xD;
             of invasive opportunistic infections despite infection resolution or otherwise&#xD;
             recurrent infections of abnormal frequency or prolonged duration.&#xD;
&#xD;
          -  Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other&#xD;
             malignancies in the last 5 years prior to Baseline (excluding in situ cervical&#xD;
             carcinoma).&#xD;
&#xD;
          -  Severe concomitant illness that would in the Investigator's opinion inhibit the&#xD;
             participant's participation in the study, including for example, but not limited to,&#xD;
             renal disease, neurological conditions, heart failure and pulmonary disease.&#xD;
&#xD;
          -  Laboratory values at the Screening Visit:&#xD;
&#xD;
          -  a. Serum creatinine &gt; 1.6 milligrams per deciliter (mg/dL) (141 micromole per liter&#xD;
             [mcmol/L]) in female participants and &gt; 1.9 mg/dL (168 mcmol/L) in male participants;&#xD;
&#xD;
          -  b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 1.5 × upper&#xD;
             limit of normal (ULN);&#xD;
&#xD;
          -  c. Platelet count &lt; 100*10^9/L;&#xD;
&#xD;
          -  d. Haemoglobin (Hb): Male &lt; 13.5 g/dL and Female &lt;12 g/dL;&#xD;
&#xD;
          -  e. White blood cell count (WBCC) &lt; 3.0*10^9/L;&#xD;
&#xD;
          -  f. Absolute neutrophil count &lt; 2.0*10^9/L;&#xD;
&#xD;
          -  g. Absolute lymphocyte count &lt; 0.5*10^9/L;&#xD;
&#xD;
          -  h. Total bilirubin &gt; ULN.&#xD;
&#xD;
          -  Participation in any other clinical study, including non-interventional studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Weidinger, MaHM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Schleswig-Holstein, 24105 Kiel, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kymab investigational site 106</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 113</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 207</name>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 216</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 206</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 212</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 213</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 214</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 203</name>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 210</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigator site 201</name>
      <address>
        <city>Rzeszow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 204</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 202</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 304</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 303</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 302</name>
      <address>
        <city>Seville</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 315</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 420</name>
      <address>
        <city>Harrogate</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 402</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>


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/NCT03754309
org study id: KY1005-CT02
secondary id: 2018-002299-41
secondary id: ACT17369
nct id: NCT03754309
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this research study is to investigate if KY1005 results in improvement of
      eczema when given to participants with moderate to severe disease. Side effects of KY1005
      will also be explored.
Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy,
      safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic
      dermatitis whose disease cannot be adequately controlled with topical medications or for whom
      topical treatment is medically inadvisable.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage change in Eczema Area and Severity Index (EASI)
time frame: Baseline to day 113
measure: Incidence of treatment-emergent adverse events (TEAEs)
time frame: Baseline to day 113
measure: Percentage and absolute change from Baseline in EASI over time
time frame: Baseline to day 113
measure: Change in epidermal thickness
time frame: Baseline to day 113
measure: Change in keratin 16 staining of skin biopsies
time frame: Baseline to day 113
measure: Percentage of patients with at least a 50% reduction in EASI (EASI 50)
time frame: Baseline to day 113
measure: Percentage of patients with at least a 75% reduction in EASI (EASI 75)
time frame: Baseline to day 113
measure: Percentage of patients with at least a 90% reduction in EASI (EASI 90)
time frame: Baseline to day 113
measure: Change in Validated Investigator Global Assessment (vIGA)
time frame: Baseline to day 113
measure: Percentage of patients with a response of vIGA 0 or 1
time frame: Baseline to day 113
measure: Change in SCORing of Atopic Dermatis (SCORAD) Index
time frame: Baseline to day 113
measure: Change in affected body surface area (BSA)
time frame: Baseline to day 113
measure: Change in Patient Orientated Eczema Measure (POEM)
time frame: Baseline to Day 113
measure: Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index
time frame: Baseline to day 113
measure: Change in Dermatology Quality of Life Index (DLQI)
time frame: Baseline to Day 113
measure: Change in Numerical Rating Scale (NRS) for pruritus
time frame: Baseline to day 113
arm group label: KY1005 lower dose
arm group type: Experimental
description: Low dose KY1005
arm group label: KY1005 higher dose
arm group type: Experimental
description: High dose KY1005
arm group label: Placebo
arm group type: Placebo Comparator
description: Matched placebo
intervention type: Drug
intervention name: KY1005
description: A human anti-OX40 ligand monoclonal antibody
arm group label: KY1005 higher dose
arm group label: KY1005 lower dose
other name: SAR445229
intervention type: Drug
intervention name: Placebo
description: Matched placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Stephan Weidinger, MaHM
role: Principal Investigator
affiliation: University Hospital Schleswig-Holstein, 24105 Kiel, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Poland
country: Spain
country: United Kingdom
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