<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/NCT03018509</url>
  </required_header>
  <id_info>
    <org_study_id>AE451-X-16-003</org_study_id>
    <nct_id>NCT03018509</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety,Tolerability,Pharmacodynamics &amp; Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JTE-451 Administered for 4 Weeks in Subjects With Active Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akros Pharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akros Pharma Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of&#xD;
      JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in the clinical target PLSS</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in the clinical target lesion erythema</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in the clinical target lesion induration</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in the clinical target lesion scaling</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the clinical target lesion sPGA score</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical target lesion sPGA scores of 0 or 1</measure>
    <time_frame>Week 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical target lesion sPGA scores of 0 or 1</measure>
    <time_frame>Week 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical target lesion sPGA scores of 0 or 1</measure>
    <time_frame>Week 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical target lesion sPGA scores of 0 or 1</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with at least a 2-point improvement in sPGA score</measure>
    <time_frame>Baseline to Week 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough concentration during multiple dosing prior to next dose (Ctrough)</measure>
    <time_frame>Weeks 1, 2, 3 and 4</time_frame>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Plaque Psoriasis</condition>
  <condition>Psoriasis</condition>
  <condition>Skin Diseases</condition>
  <arm_group>
    <arm_group_label>JTE-451 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTE-451 dose 1 for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTE-451 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTE-451 dose 2 for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTE-451 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTE-451 dose 3 for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTE-451 Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JTE-451 dose 4 for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JTE-451</intervention_name>
    <description>Active drug tablets containing JTE-451</description>
    <arm_group_label>JTE-451 Dose 1</arm_group_label>
    <arm_group_label>JTE-451 Dose 2</arm_group_label>
    <arm_group_label>JTE-451 Dose 3</arm_group_label>
    <arm_group_label>JTE-451 Dose 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets identical in appearance to the active drug tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy&#xD;
             target lesion).&#xD;
&#xD;
          -  Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6&#xD;
&#xD;
          -  Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to &gt;2 systemic biologic agents and/or small molecules including&#xD;
             investigational therapies for the treatment of psoriasis or have not discontinued&#xD;
             systemic biologic agents and/or small molecules anti-psoriasis therapy including&#xD;
             investigational therapies due to lack of efficacy;&#xD;
&#xD;
          -  Subjects with significant health problems, other than having plaque psoriasis (as&#xD;
             determined by medical history, physical examination, chest X-ray, vital signs and&#xD;
             12-lead ECG) that could either interfere with study evaluations or place subject at&#xD;
             undue risk;&#xD;
&#xD;
          -  Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,&#xD;
             medication-induced psoriasis at Visit 1;&#xD;
&#xD;
          -  Conditions (e.g., clinically-significant eczema or severe acne in the target lesion&#xD;
             area) that would interfere with study evaluations;&#xD;
&#xD;
          -  Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle&#xD;
             bacillus (TB) or lack any other evidence of active or latent TB;&#xD;
&#xD;
          -  History of a clinically-significant infection (e.g., required oral antimicrobial&#xD;
             therapy) within 4 weeks prior to Visit 2;&#xD;
&#xD;
          -  Subjects who do not have clinical laboratory test results within the normal reference&#xD;
             ranges (i.e., are deemed not to be clinically significant) or clinically not&#xD;
             acceptable to the Investigator;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>June 29, 2017</last_update_submitted>
  <last_update_submitted_qc>June 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JTE-451</keyword>
  <keyword>psoriasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Skin Diseases</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/NCT03018509
org study id: AE451-X-16-003
nct id: NCT03018509
lead sponsor: 
has dmc: No
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of
      JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of adverse events
time frame: 4 weeks
measure: Percent change from baseline in the clinical target PLSS
time frame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion erythema
time frame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion induration
time frame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion scaling
time frame: Weeks 1, 2, 3 and 4
measure: Change from baseline in the clinical target lesion sPGA score
time frame: Weeks 1, 2, 3 and 4
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
time frame: Week 1
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
time frame: Week 2
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
time frame: Week 3
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
time frame: Week 4
measure: Number of subjects with at least a 2-point improvement in sPGA score
time frame: Baseline to Week 4
measure: Trough concentration during multiple dosing prior to next dose (Ctrough)
time frame: Weeks 1, 2, 3 and 4
arm group label: JTE-451 Dose 1
arm group type: Experimental
description: JTE-451 dose 1 for 28 days
arm group label: JTE-451 Dose 2
arm group type: Experimental
description: JTE-451 dose 2 for 28 days
arm group label: JTE-451 Dose 3
arm group type: Experimental
description: JTE-451 dose 3 for 28 days
arm group label: JTE-451 Dose 4
arm group type: Experimental
description: JTE-451 dose 4 for 28 days
arm group label: Placebo
arm group type: Experimental
description: Placebo for 28 days
intervention type: Drug
intervention name: JTE-451
description: Active drug tablets containing JTE-451
arm group label: JTE-451 Dose 1
arm group label: JTE-451 Dose 2
arm group label: JTE-451 Dose 3
arm group label: JTE-451 Dose 4
intervention type: Drug
intervention name: Placebo
description: Placebo tablets identical in appearance to the active drug tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Skin Diseases
sharing ipd: No