<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/NCT03000309</url>
  </required_header>
  <id_info>
    <org_study_id>APR-2015</org_study_id>
    <nct_id>NCT03000309</nct_id>
  </id_info>
  <brief_title>Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy</brief_title>
  <official_title>Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derm Research, PLLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Derm Research, PLLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sixteen week open label study of apremilast in combination with topical steroids with a four&#xD;
      week safety follow up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, 16 week study of apremilast in combination with topical&#xD;
      corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of&#xD;
      Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment.&#xD;
      Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used&#xD;
      for up to Week 4 as per label and then will be used on an as needed basis until Week 16.&#xD;
      Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity&#xD;
      Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index&#xD;
      (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global&#xD;
      Assessment (PtGA)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">April 25, 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in Product of BSA and sPGA</measure>
    <time_frame>Week 16</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Product of BSA and sPGA</measure>
    <time_frame>Week 8</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in DLQI</measure>
    <time_frame>Week 8</time_frame>
    <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in DLQI</measure>
    <time_frame>Week 16</time_frame>
    <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Pruritus Scores</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Pruritus Scores</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in BSA</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in BSA</measure>
    <time_frame>Week 16</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in BSA</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in BSA</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Achieve PASI 50</measure>
    <time_frame>Week 8</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Achieve PASI 50</measure>
    <time_frame>Week 16</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Achieve PASI 75</measure>
    <time_frame>Week 8</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Achieve PASI 75</measure>
    <time_frame>Week 16</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of Patients Achieving Clear or Almost Clear on the PtGA</measure>
    <time_frame>Week 8</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of Patients Achieving Clear or Almost Clear on the PtGA</measure>
    <time_frame>Week 16</time_frame>
    <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Apremilast</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <arm_group_label>Apremilast</arm_group_label>
    <other_name>Otezla</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be in general good health as judged by investigator&#xD;
&#xD;
          -  Female of childbearing potential (FCBP) must have a negative pregnancy test at&#xD;
             screening and Baseline.&#xD;
&#xD;
          -  FCBP must use an approved method of contraception as outlined in the protocol.&#xD;
&#xD;
          -  Male subjects who engage in activity in which conception is possible must use barrier&#xD;
             contraception as defined in the protocol.&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Understand and voluntarily sign the Informed Consent&#xD;
&#xD;
          -  Able to adhere to study visit schedule&#xD;
&#xD;
          -  Moderate plaque type psoriasis as define by a a PGA of 3&#xD;
&#xD;
          -  BSA 0f 5-10% or a DLQI score of 7 or more&#xD;
&#xD;
          -  History of uncontrolled plaque psoriasis after either stable dose of high potency&#xD;
             topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant disease as determined by the investigator or major disease&#xD;
             that is currently uncontrolled&#xD;
&#xD;
          -  Any condition, including the presence of laboratory abnormalities, which would place&#xD;
             the subject at unacceptable risk&#xD;
&#xD;
          -  Prior history of suicide attempt at any time in the subject's lifetime prior to&#xD;
             screening or randomization, or major psychiatric illness requiring hospitalization&#xD;
             within the last 3 years&#xD;
&#xD;
          -  Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control&#xD;
             methods.&#xD;
&#xD;
          -  Active substance abuse or a history of substance abuse within 6 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  Malignancy or history of malignancy except fo treated (cured) basal cell or or&#xD;
             squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial&#xD;
             neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the&#xD;
             previous 5 years&#xD;
&#xD;
          -  Has not completed the prescribed washout for restricted treatments&#xD;
&#xD;
          -  Known or suspected allergy to investigational product&#xD;
&#xD;
          -  Other types of psoriasis&#xD;
&#xD;
          -  Prior history of depression&#xD;
&#xD;
          -  Prior use of apremilast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leon H. Kircik, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>DermResearch PLLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DermResearch, PLLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>February 7, 2019</results_first_submitted>
  <results_first_submitted_qc>March 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 28, 2019</results_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apremilast</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03000309/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Apremilast</title>
          <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Apremilast</title>
          <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="14"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>white</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
          <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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Product of BSA and sPGA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Product of BSA and sPGA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44" spread="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Product of BSA and sPGA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Product of BSA and sPGA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in DLQI</title>
        <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in DLQI</title>
          <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
          <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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in DLQI</title>
        <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in DLQI</title>
          <description>The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.</description>
          <units>units 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Pruritus Scores</title>
        <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
        <time_frame>Baseline to Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Pruritus Scores</title>
          <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
          <units>units 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Pruritus Scores</title>
        <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
        <time_frame>Baseline to Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Pruritus Scores</title>
          <description>The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)</description>
          <units>units 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in BSA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
        <time_frame>Baseline to Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in BSA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
          <units>percentage of body surface area affected</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in BSA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in BSA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
          <units>percentage of body surface area affected</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in BSA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
        <time_frame>Baseline to Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in BSA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in BSA</title>
        <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
        <time_frame>Baseline to Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in BSA</title>
          <description>The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36" spread="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Achieve PASI 50</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Achieve PASI 50</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Achieve PASI 50</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Achieve PASI 50</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Achieve PASI 75</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Achieve PASI 75</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Achieve PASI 75</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Achieve PASI 75</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% of Patients Achieving Clear or Almost Clear on the PtGA</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>% of Patients Achieving Clear or Almost Clear on the PtGA</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% of Patients Achieving Clear or Almost Clear on the PtGA</title>
        <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Apremilast</title>
            <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>% of Patients Achieving Clear or Almost Clear on the PtGA</title>
          <description>The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Apremilast</title>
          <description>Apremilast, 30 mg. tablets, two times a day for 16 weeks&#xD;
Apremilast</description>
        </group>
      </group_list>
      <serious_events>
        <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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="17" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>upset stomach, unspecified</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>abdominal cramping</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>viral gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>heartburn</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>irritability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>leg cramps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>right flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>upper respiratory infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>cyst left inner thigh</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>abscess right hand</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>M. McAllister</name_or_title>
      <organization>Skin Sciences, PLLC</organization>
      <phone>5024519000</phone>
      <email>mmdermresearch@yahoo.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/NCT03000309
org study id: APR-2015
nct id: NCT03000309
lead sponsor: 
collaborator: 
has dmc: No
Sixteen week open label study of apremilast in combination with topical steroids with a four
      week safety follow up visit.
This is an open label, 16 week study of apremilast in combination with topical
      corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of
      Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment.
      Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used
      for up to Week 4 as per label and then will be used on an as needed basis until Week 16.
      Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity
      Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index
      (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global
      Assessment (PtGA)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16
time frame: Week 16
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.
measure: Percent Change in Product of BSA and sPGA
time frame: Week 16
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.
measure: Percent Change in Product of BSA and sPGA
time frame: Week 8
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)
measure: Mean Change in DLQI
time frame: Week 8
description: The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.
measure: Mean Change in DLQI
time frame: Week 16
description: The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.
measure: Mean Change in Pruritus Scores
time frame: Baseline to Week 8
description: The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)
measure: Mean Change in Pruritus Scores
time frame: Baseline to Week 16
description: The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)
measure: Mean Change in BSA
time frame: Baseline to Week 8
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16
measure: Mean Change in BSA
time frame: Week 16
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16
measure: Percent Change in BSA
time frame: Baseline to Week 8
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16
measure: Percent Change in BSA
time frame: Baseline to Week 16
description: The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16
measure: Proportion of Patients Who Achieve PASI 50
time frame: Week 8
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
measure: Proportion of Patients Who Achieve PASI 50
time frame: Week 16
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
measure: Proportion of Patients Who Achieve PASI 75
time frame: Week 8
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
measure: Proportion of Patients Who Achieve PASI 75
time frame: Week 16
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
measure: % of Patients Achieving Clear or Almost Clear on the PtGA
time frame: Week 8
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
measure: % of Patients Achieving Clear or Almost Clear on the PtGA
time frame: Week 16
description: The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)
arm group label: Apremilast
arm group type: Other
description: Apremilast, 30 mg. tablets, two times a day for 16 weeks
intervention type: Drug
intervention name: Apremilast
arm group label: Apremilast
other name: Otezla
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leon H. Kircik, M.D.
role: Principal Investigator
affiliation: DermResearch PLLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Apremilast
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 