<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/NCT03832738</url>
  </required_header>
  <id_info>
    <org_study_id>AE451-G-18-004</org_study_id>
    <nct_id>NCT03832738</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis</brief_title>
  <acronym>IMPACT-PS</acronym>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (IMPACT-PS)</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects&#xD;
      with moderate to severe plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">March 13, 2020</completion_date>
  <primary_completion_date type="Actual">March 13, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in PASI score was calculated by taking the PASI score at EOT and subtracting the baseline PASI score, then dividing by the baseline PASI score and multiplying by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
For this outcome measure, at EOT (up to 16 weeks), a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
Change from baseline to EOT (up to 16 weeks) in sPGA score was calculated by taking the sPGA score at EOT and subtracting the baseline sPGA score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100).&#xD;
BSA (%)=0.1Sh+0.2Su+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in BSA was calculated by taking the EOT BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100.&#xD;
A negative change from baseline at EOT indicates a reduction in the Psoriasis BSA compared to the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Skindex-16 Overall Score at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Overall Score was calculated by taking the EOT Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Symptoms Scale Score was calculated by taking the EOT Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Emotions Scale Score was calculated by taking the EOT Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Functioning Scale Score was calculated by taking the EOT Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT</measure>
    <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
    <description>The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. The Itch NRS scores were recorded by the subject using the e-diary once daily from screening through the last visit.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Itch NRS Score was calculated by taking the Itch NRS Score (weekly average) at EOT and subtracting the baseline Itch NRS Score (weekly average).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Treatment-emergent Adverse Events</measure>
    <time_frame>Follow-up (Up to 20 Weeks)</time_frame>
    <description>Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).&#xD;
The treatment-emergent adverse event (TEAE) is defined as one of the following:&#xD;
An adverse event (AE) that occurred during the treatment period or the follow-up period. In the process of collecting the onset dates of AEs, an AE that occurs after the initiation of trial medication on Day 1 (the first day of the treatment period) should be treated as a TEAE. All AEs occurring on the day of first dose will be considered as TEAE if the time of AE occurrence relative to the dosing is unknown.&#xD;
An AE present prior to the treatment period that worsened in severity during the treatment period or the follow-up period.&#xD;
Any events that are present prior to the treatment period and have recovered, but recurred during the treatment period or the follow-up period should be considered as new TEAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>JTE-451 Trough Plasma Concentrations at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentration of JTE-451 in the pharmacokinetic (PK) population.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">152</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 Tablets Dose 1 daily for 16 weeks.</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 Tablets Dose 2 daily for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Tablets daily for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JTE-451 Tablets</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>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tablets</intervention_name>
    <description>Placebo tablets matching in appearance to the active drug tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had a history of moderate to severe plaque psoriasis for at least 6 months prior&#xD;
             to Visit 1;&#xD;
&#xD;
          -  Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area&#xD;
             (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's&#xD;
             Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of discontinuation of biologic therapies (including marketed and&#xD;
             investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17&#xD;
             receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the&#xD;
             Investigator's judgment;&#xD;
&#xD;
          -  Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;&#xD;
&#xD;
          -  Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,&#xD;
             medication-induced psoriasis or other skin conditions (e.g., clinically-significant&#xD;
             eczema or severe acne) at Visit 1;&#xD;
&#xD;
          -  History or presence of itch due to underlying conditions other than plaque psoriasis&#xD;
             which cause or influence pruritus of the skin within 12 months prior to Visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Science Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Dermatology and Skin Cancer Specialists</name>
      <address>
        <city>Temecula</city>
        <state>California</state>
        <zip>92592</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</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>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wiseman Dermatology Research Inc.</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3M 3Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SimcoDerm Medical and Surgical Dermatology Center</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKiN Health</name>
      <address>
        <city>Cobourg</city>
        <state>Ontario</state>
        <zip>K9A 0B3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4W 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K. Papp Clinical Research</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Research Sherbrooke Inc.</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1L 0H8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 1 im. Dr. A. Jurasza w Bydgoszczy, Klinika Dermatologii, Chorob Prenoszonych Droga Plciowa</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-094</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii</name>
      <address>
        <city>Gdansk</city>
        <zip>80-152</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatny Gabinet Dermatologiczny Elzbieta Klujszo</name>
      <address>
        <city>Kielce</city>
        <zip>25-316</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Nowoczesnych Terapii &quot;Dobry Lekarz&quot; Spolka z orgraniczona odpowiedzialnoscia</name>
      <address>
        <city>Krakow</city>
        <zip>31-011</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>90-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak</name>
      <address>
        <city>Lodz</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Lublin</name>
      <address>
        <city>Lublin</city>
        <zip>20-412</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Grunwald</name>
      <address>
        <city>Poznan</city>
        <zip>60-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solumed Centrum Medyczne</name>
      <address>
        <city>Poznan</city>
        <zip>60-529</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Siedlce</name>
      <address>
        <city>Siedlce</city>
        <zip>08-110</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Skierniewice</name>
      <address>
        <city>Skierniewice</city>
        <zip>96-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Group Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>01-142</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorota Bystrzanowska &quot;High-Med&quot; Przychodnia Specjalistyczna</name>
      <address>
        <city>Warszawa</city>
        <zip>01-817</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carpe Diem Centrum Medycyny Estetycznej</name>
      <address>
        <city>Warszawa</city>
        <zip>02-661</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royalderm Agnieszka Nawrocka</name>
      <address>
        <city>Warszawa</city>
        <zip>02-692</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Warszawa</name>
      <address>
        <city>Warszawa</city>
        <zip>02-777</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-566</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMMEDICA Sp. z o.o.</name>
      <address>
        <city>Wrocław</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Zamosc</name>
      <address>
        <city>Zamosc</city>
        <zip>22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>July 21, 2021</results_first_submitted>
  <results_first_submitted_qc>July 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2021</results_first_posted>
  <disposition_first_submitted>March 3, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>March 4, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 8, 2021</disposition_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JTE-451</keyword>
  <keyword>Psoriasis</keyword>
  <keyword>Plaque psoriasis</keyword>
  <keyword>IMPACT-PS</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03832738/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03832738/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.</recruitment_details>
      <pre_assignment_details>Following informed consent signing, screening procedures to confirm eligibility were performed.&#xD;
Intent-to-Treat (ITT) Population - 152 subjects&#xD;
Safety Population - 151 subjects&#xD;
Pharmacokinetic (PK) Population - 101 subjects</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>JTE-451 200 mg Twice Daily</title>
          <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
        </group>
        <group group_id="P2">
          <title>JTE-451 400 mg Twice Daily</title>
          <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
        </group>
        <group group_id="P3">
          <title>Placebo Twice Daily</title>
          <description>Placebo Tablets orally twice daily for 16 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics results are reported for the Intent-to-Treat (ITT) population: 152 randomized subjects</population>
      <group_list>
        <group group_id="B1">
          <title>JTE-451 200 mg Twice Daily</title>
          <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
        </group>
        <group group_id="B2">
          <title>JTE-451 400 mg Twice Daily</title>
          <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
        </group>
        <group group_id="B3">
          <title>Placebo Twice Daily</title>
          <description>Placebo Tablets orally twice daily for 16 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="152"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior exposure to biologics therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Had prior biologics therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No prior biologics therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body weight</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Below 90 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>90 kg or above</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)</title>
        <description>The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)</title>
          <description>The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% of subjects achieving PASI-75</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="22.0"/>
                    <measurement group_id="O3" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.558</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>5.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.035</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>13.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT</title>
        <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT</title>
          <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% of subjects achieving PASI-50</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="42.0"/>
                    <measurement group_id="O3" value="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.086</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>5.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.45</ci_lower_limit>
            <ci_upper_limit>9.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT</title>
        <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT</title>
          <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% of subjects achieving PASI-90</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="6.0"/>
                    <measurement group_id="O3" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.999</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>17.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.244</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>41.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT</title>
        <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in PASI score was calculated by taking the PASI score at EOT and subtracting the baseline PASI score, then dividing by the baseline PASI score and multiplying by 100.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT</title>
          <description>The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).&#xD;
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in PASI score was calculated by taking the PASI score at EOT and subtracting the baseline PASI score, then dividing by the baseline PASI score and multiplying by 100.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% change in PASI Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.33" spread="40.971"/>
                    <measurement group_id="O2" value="-37.89" spread="37.896"/>
                    <measurement group_id="O3" value="-17.53" spread="34.701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT</title>
        <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
For this outcome measure, at EOT (up to 16 weeks), a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT</title>
          <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
For this outcome measure, at EOT (up to 16 weeks), a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% of subjects achieving sPGA 0 or 1</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5"/>
                    <measurement group_id="O2" value="28.0"/>
                    <measurement group_id="O3" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.38</ci_lower_limit>
            <ci_upper_limit>19.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (&lt;90 kg/≥90 kg).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.86</ci_lower_limit>
            <ci_upper_limit>29.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT</title>
        <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
Change from baseline to EOT (up to 16 weeks) in sPGA score was calculated by taking the sPGA score at EOT and subtracting the baseline sPGA score.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT</title>
          <description>The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).&#xD;
Change from baseline to EOT (up to 16 weeks) in sPGA score was calculated by taking the sPGA score at EOT and subtracting the baseline sPGA score.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" spread="0.848"/>
                    <measurement group_id="O2" value="-1.02" spread="0.869"/>
                    <measurement group_id="O3" value="-0.54" spread="0.713"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT</title>
        <description>The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100).&#xD;
BSA (%)=0.1Sh+0.2Su+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in BSA was calculated by taking the EOT BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100.&#xD;
A negative change from baseline at EOT indicates a reduction in the Psoriasis BSA compared to the baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT</title>
          <description>The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100).&#xD;
BSA (%)=0.1Sh+0.2Su+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.&#xD;
Percent change from baseline to EOT (up to 16 weeks) in BSA was calculated by taking the EOT BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100.&#xD;
A negative change from baseline at EOT indicates a reduction in the Psoriasis BSA compared to the baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>% Change in Psoriasis BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.67" spread="39.582"/>
                    <measurement group_id="O2" value="-19.03" spread="48.696"/>
                    <measurement group_id="O3" value="-5.74" spread="38.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Skindex-16 Overall Score at EOT</title>
        <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Overall Score was calculated by taking the EOT Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Skindex-16 Overall Score at EOT</title>
          <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Overall Score was calculated by taking the EOT Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.029" spread="23.2635"/>
                    <measurement group_id="O2" value="-10.896" spread="26.7910"/>
                    <measurement group_id="O3" value="-3.386" spread="20.8617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT</title>
        <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Symptoms Scale Score was calculated by taking the EOT Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT</title>
          <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Symptoms Scale Score was calculated by taking the EOT Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.905" spread="34.2989"/>
                    <measurement group_id="O2" value="-11.500" spread="31.5148"/>
                    <measurement group_id="O3" value="-2.170" spread="26.0563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT</title>
        <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Emotions Scale Score was calculated by taking the EOT Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT</title>
          <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Emotions Scale Score was calculated by taking the EOT Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.411" spread="21.8268"/>
                    <measurement group_id="O2" value="-13.143" spread="28.4467"/>
                    <measurement group_id="O3" value="-5.953" spread="22.6358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT</title>
        <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Functioning Scale Score was calculated by taking the EOT Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT</title>
          <description>Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses are categorized into 3 subscales: symptom, emotional &amp; functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Functioning Scale Score was calculated by taking the EOT Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score.&#xD;
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.392" spread="23.5294"/>
                    <measurement group_id="O2" value="-7.267" spread="27.6823"/>
                    <measurement group_id="O3" value="-0.764" spread="20.1090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT</title>
        <description>The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. The Itch NRS scores were recorded by the subject using the e-diary once daily from screening through the last visit.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Itch NRS Score was calculated by taking the Itch NRS Score (weekly average) at EOT and subtracting the baseline Itch NRS Score (weekly average).</description>
        <time_frame>End of Treatment (Up to 16 Weeks)</time_frame>
        <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT</title>
          <description>The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. The Itch NRS scores were recorded by the subject using the e-diary once daily from screening through the last visit.&#xD;
Change from baseline to EOT (up to 16 weeks) in the Itch NRS Score was calculated by taking the Itch NRS Score (weekly average) at EOT and subtracting the baseline Itch NRS Score (weekly average).</description>
          <population>Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.302" spread="2.8165"/>
                    <measurement group_id="O2" value="-1.537" spread="3.2634"/>
                    <measurement group_id="O3" value="-0.547" spread="2.4239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Treatment-emergent Adverse Events</title>
        <description>Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).&#xD;
The treatment-emergent adverse event (TEAE) is defined as one of the following:&#xD;
An adverse event (AE) that occurred during the treatment period or the follow-up period. In the process of collecting the onset dates of AEs, an AE that occurs after the initiation of trial medication on Day 1 (the first day of the treatment period) should be treated as a TEAE. All AEs occurring on the day of first dose will be considered as TEAE if the time of AE occurrence relative to the dosing is unknown.&#xD;
An AE present prior to the treatment period that worsened in severity during the treatment period or the follow-up period.&#xD;
Any events that are present prior to the treatment period and have recovered, but recurred during the treatment period or the follow-up period should be considered as new TEAEs.</description>
        <time_frame>Follow-up (Up to 20 Weeks)</time_frame>
        <population>Safety Population (151, randomized subjects who received at least one dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily</title>
            <description>Placebo Tablets orally twice daily for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment-emergent Adverse Events</title>
          <description>Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).&#xD;
The treatment-emergent adverse event (TEAE) is defined as one of the following:&#xD;
An adverse event (AE) that occurred during the treatment period or the follow-up period. In the process of collecting the onset dates of AEs, an AE that occurs after the initiation of trial medication on Day 1 (the first day of the treatment period) should be treated as a TEAE. All AEs occurring on the day of first dose will be considered as TEAE if the time of AE occurrence relative to the dosing is unknown.&#xD;
An AE present prior to the treatment period that worsened in severity during the treatment period or the follow-up period.&#xD;
Any events that are present prior to the treatment period and have recovered, but recurred during the treatment period or the follow-up period should be considered as new TEAEs.</description>
          <population>Safety Population (151, randomized subjects who received at least one dose of study drug).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of subjects with TEAEs</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of subjects with no TEAEs</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>JTE-451 Trough Plasma Concentrations at Week 16</title>
        <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentration of JTE-451 in the pharmacokinetic (PK) population.</description>
        <time_frame>Week 16</time_frame>
        <population>Subjects (75 subjects) in the PK population at Week 16 with available trough plasma concentrations of JTE-451 (subjects who received at least one dose of JTE-451 and have at least one usable JTE-451 plasma concentration measurement at Week 16).</population>
        <group_list>
          <group group_id="O1">
            <title>JTE-451 200 mg Twice Daily</title>
            <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
          </group>
          <group group_id="O2">
            <title>JTE-451 400 mg Twice Daily</title>
            <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>JTE-451 Trough Plasma Concentrations at Week 16</title>
          <description>Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentration of JTE-451 in the pharmacokinetic (PK) population.</description>
          <population>Subjects (75 subjects) in the PK population at Week 16 with available trough plasma concentrations of JTE-451 (subjects who received at least one dose of JTE-451 and have at least one usable JTE-451 plasma concentration measurement at Week 16).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575" spread="704"/>
                    <measurement group_id="O2" value="1210" spread="1660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 20 Weeks</time_frame>
      <desc>Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).</desc>
      <group_list>
        <group group_id="E1">
          <title>JTE-451 200 mg Twice Daily</title>
          <description>JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)</description>
        </group>
        <group group_id="E2">
          <title>JTE-451 400 mg Twice Daily</title>
          <description>JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)</description>
        </group>
        <group group_id="E3">
          <title>Placebo Twice Daily</title>
          <description>Placebo Tablets orally twice daily for 16 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Breast Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E2" events="30" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kazuhiro Okamiya</name_or_title>
      <organization>Akros Pharma Inc.</organization>
      <phone>609-919-6123</phone>
      <email>okamiya@akrospharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03832738
org study id: AE451-G-18-004
nct id: NCT03832738
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects
      with moderate to severe plaque psoriasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)
time frame: End of Treatment (Up to 16 Weeks)
description: The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
measure: Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
measure: Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Percent change from baseline to EOT (up to 16 weeks) in PASI score was calculated by taking the PASI score at EOT and subtracting the baseline PASI score, then dividing by the baseline PASI score and multiplying by 100.
measure: Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).
For this outcome measure, at EOT (up to 16 weeks), a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.
measure: Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptoms] to 4 [severe symptoms]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).
Change from baseline to EOT (up to 16 weeks) in sPGA score was calculated by taking the sPGA score at EOT and subtracting the baseline sPGA score.
measure: Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100).
BSA (%)=0.1Sh+0.2Su+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
Percent change from baseline to EOT (up to 16 weeks) in BSA was calculated by taking the EOT BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100.
A negative change from baseline at EOT indicates a reduction in the Psoriasis BSA compared to the baseline.
measure: Change From Baseline in the Skindex-16 Overall Score at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100.
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Overall Score was calculated by taking the EOT Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score.
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
measure: Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100.
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Symptoms Scale Score was calculated by taking the EOT Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score.
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
measure: Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100.
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Emotions Scale Score was calculated by taking the EOT Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score.
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
measure: Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100.
Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Functioning Scale Score was calculated by taking the EOT Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score.
A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
measure: Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT
time frame: End of Treatment (Up to 16 Weeks)
description: The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. The Itch NRS scores were recorded by the subject using the e-diary once daily from screening through the last visit.
Change from baseline to EOT (up to 16 weeks) in the Itch NRS Score was calculated by taking the Itch NRS Score (weekly average) at EOT and subtracting the baseline Itch NRS Score (weekly average).
measure: Number of Subjects With Treatment-emergent Adverse Events
time frame: Follow-up (Up to 20 Weeks)
description: Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
The treatment-emergent adverse event (TEAE) is defined as one of the following:
An adverse event (AE) that occurred during the treatment period or the follow-up period. In the process of collecting the onset dates of AEs, an AE that occurs after the initiation of trial medication on Day 1 (the first day of the treatment period) should be treated as a TEAE. All AEs occurring on the day of first dose will be considered as TEAE if the time of AE occurrence relative to the dosing is unknown.
An AE present prior to the treatment period that worsened in severity during the treatment period or the follow-up period.
Any events that are present prior to the treatment period and have recovered, but recurred during the treatment period or the follow-up period should be considered as new TEAEs.
measure: JTE-451 Trough Plasma Concentrations at Week 16
time frame: Week 16
description: Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentration of JTE-451 in the pharmacokinetic (PK) population.
arm group label: JTE-451 Dose 1
arm group type: Experimental
description: JTE-451 Tablets Dose 1 daily for 16 weeks.
arm group label: JTE-451 Dose 2
arm group type: Experimental
description: JTE-451 Tablets Dose 2 daily for 16 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Tablets daily for 16 weeks.
intervention type: Drug
intervention name: JTE-451 Tablets
description: Active drug tablets containing JTE-451
arm group label: JTE-451 Dose 1
arm group label: JTE-451 Dose 2
intervention type: Drug
intervention name: Placebo Tablets
description: Placebo tablets matching in appearance to the active drug tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Skin Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 