<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/NCT03022617</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-160720004</org_study_id>
    <nct_id>NCT03022617</nct_id>
  </id_info>
  <brief_title>An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red&#xD;
      itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the&#xD;
      finger and toe nails. The most characteristic nail findings associated with nail psoriasis&#xD;
      are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis&#xD;
      causes a substantial disease burden for patients, it is critical that safe and effective&#xD;
      treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is&#xD;
      often difficult to treat.&#xD;
&#xD;
      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that&#xD;
      is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown&#xD;
      promising results for treating psoriatic arthritis and nail disease; however more data is&#xD;
      needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that&#xD;
      apremilast will prove to be highly effective in treating nail psoriasis. We propose to&#xD;
      conduct an open label clinical trial to investigate the efficacy and tolerability of&#xD;
      apremilast in treating nail psoriasis, where we will follow the package insert guidelines for&#xD;
      treating patients with apremilast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red&#xD;
      itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the&#xD;
      finger and toe nails. Nail psoriasis is a chronic disease and can present with the following&#xD;
      clinical findings: splinter hemorrhage, leukonychia, red spots in the lunula, nail pitting,&#xD;
      nail plate crumbling, hyperkeratosis, and/or nail plate separation from the nail bed. The&#xD;
      most characteristic nail findings associated with nail psoriasis are nail pitting,&#xD;
      onycholysis with a rim of erythema, and oil spots. Special interest will be paid to&#xD;
      identifying these particular nail findings in patients, however all potential nail psoriasis&#xD;
      symptoms will be assessed in patients in this study. Due to the highly visible nature of&#xD;
      disease in the fingernails, nail psoriasis often results in a substantial deleterious effect&#xD;
      on a patient's quality of life. Patients also can have significant pain and disability due to&#xD;
      nail psoriasis.&#xD;
&#xD;
      Psoriasis patients who have nail involvement are known to have more severe psoriasis disease&#xD;
      and diminished quality of life when compared to psoriasis patients without nail disease.&#xD;
      Patients with nail psoriasis often also have psoriatic arthritis, and untreated psoriatic&#xD;
      arthritis is known to lead to joint destruction with potentially severe morbidity. Nail&#xD;
      psoriasis has a reported incidence of 80 to 90% (Jiaravuthiasan, et al). Because nail&#xD;
      psoriasis causes a substantial disease burden for patients, it is critical that safe and&#xD;
      effective treatments are found for this specific type of psoriasis. Unfortunately, nail&#xD;
      psoriasis is often difficult to treat.&#xD;
&#xD;
      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that&#xD;
      is FDA approved for the treatment of psoriasis and psoriatic arthritis. PDE4 is one of the&#xD;
      main phosphodiesterases expressed in immune cells, and its inhibition by apremilast is&#xD;
      thought to increase cyclic adenosine monophosphate and thereby decrease the inflammatory&#xD;
      response. Specifically, apremilast is believed to down regulate pro-inflammatory cytokines&#xD;
      including TNF-α, (Tumor necrosis Factor) IL-23 (Interleukin), IL-17, and others.&#xD;
&#xD;
      Apremilast has shown promising results for treating psoriatic arthritis and nail disease;&#xD;
      however more data is needed regarding its effect on nail psoriasis (Kavanaugh, et al). We&#xD;
      hypothesize that apremilast will prove to be highly effective in treating nail psoriasis. We&#xD;
      propose to conduct an open label clinical trial to investigate the efficacy and tolerability&#xD;
      of apremilast in treating nail psoriasis, where we will follow the package insert guidelines&#xD;
      for treating patients with apremilast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 29, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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 Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.</measure>
    <time_frame>36 weeks</time_frame>
    <description>mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.</measure>
    <time_frame>12, 24, 36, 48, and 52 weeks</time_frame>
    <description>The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving mNAPSI of 0 in All Fingernails at Weeks 36 and 52.</measure>
    <time_frame>36 and 52 weeks</time_frame>
    <description>mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.</measure>
    <time_frame>52 weeks</time_frame>
    <description>Nail pain VAS is a subjective survey completed by patients. Scores range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Change in Psoriatic Arthritis Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.</measure>
    <time_frame>52 weeks</time_frame>
    <description>Symptoms will be assessed using a visual analogue scale (VAS) for reporting psoriatic arthritis pain, which is a subjective survey that patients will complete on a scale of 1 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Adverse Effects Will be Assessed at Each Visit</measure>
    <time_frame>52 weeks</time_frame>
    <description>Patients will be asked about illnesses and other health related events while taking part in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving a mNAPSI 75 Response, as Defined by 75% or Greater Reduction Over Baseline in mNAPSI Score at Weeks 12, 24, 36, 48, and 52 for the Target Fingernail.</measure>
    <time_frame>12, 24, 36, 48, and 52 weeks</time_frame>
    <description>The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in the Total Number of Nails Involved Assessed at Weeks 36 and 52 Compared to Baseline.</measure>
    <time_frame>36 and 52 weeks</time_frame>
    <description>Health care providers to assess number of nails involved.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Psoriatic Nail</condition>
  <condition>Psoriasis Vulgaris</condition>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label drug administration group. No comparator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Patients older than 18&#xD;
&#xD;
          -  Give written informed consent prior to any study procedures being conducted, and&#xD;
             candidates will authorize the release and use of protected health information (PHI)&#xD;
&#xD;
          -  Be willing and consent to having photos taken of their fingernails&#xD;
&#xD;
          -  Diagnosis of chronic plaque psoriasis that has been present for at least 6 months&#xD;
             prior to baseline&#xD;
&#xD;
          -  Plaque psoriasis involving at least 5% of the patient's body surface area&#xD;
&#xD;
          -  Nail psoriasis in at least one finger nail with a mNAPSI of 5 or greater&#xD;
&#xD;
          -  A Nail Pain VAS score of 4 or higher. The Nail Pain VAS will assess the severity of&#xD;
             pain linked to the nail disease.&#xD;
&#xD;
          -  Must have discontinued all systemic therapies for the treatment of psoriasis or&#xD;
             psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics 2 months or 5&#xD;
             half-lives (whichever is longer) prior to baseline visit&#xD;
&#xD;
          -  Must have discontinued all topical therapies for the treatment of psoriasis at least 2&#xD;
             weeks prior to baseline visit&#xD;
&#xD;
          -  Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA&#xD;
             (psoralen ultraviolet light therapy) at least 4 weeks prior to baseline.&#xD;
&#xD;
          -  Subjects must be in good general health without significant uncontrolled&#xD;
             comorbidities, other than psoriasis, as determined by the investigator based on exam&#xD;
             findings, medical history, and clinical laboratories. Patients with stable mild renal&#xD;
             insufficiency are eligible for enrolling in this trial.&#xD;
&#xD;
          -  Females of childbearing potential must use an approved birth control method while&#xD;
             receiving treatment and for 28 days following the last dose of apremilast, and there&#xD;
             must be a documented negative pregnancy tests prior to initiating treatment. Approved&#xD;
             birth control methods include hormonal contraception (oral, injection, implant,&#xD;
             transdermal patch, vaginal ring), intrauterine device, partners vasectomy, or male or&#xD;
             female condoms that are not made of natural materials plus a diaphragm with&#xD;
             spermicide, cervical cap with spermicide, or a contraceptive sponge with spermicide.&#xD;
             Females not of child bearing potential are defined as being at least 1 year&#xD;
             postmenopausal or surgically sterile (bilateral tubal ligation, bilateral oophorectomy&#xD;
             and/or hysterectomy).&#xD;
&#xD;
          -  Male subjects, including those who have had a vasectomy, must use condoms not made of&#xD;
             natural materials for the duration of the trial and for at least 28 days after the&#xD;
             last dose of apremilast if conception is possible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Unable to comply with the protocol (as defined by the Investigator; i.e. drug or&#xD;
             alcohol abuse or history of noncompliance)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Female patients of childbearing potential and male patients who engage in activity&#xD;
             where contraception is possible who are unable to use the approved methods of&#xD;
             contraception throughout the length of the study and 28 days following the last dose&#xD;
&#xD;
          -  Patients who have or have had thoughts of suicide or hurting themselves.&#xD;
&#xD;
          -  Patients with prior exposure to apremilast&#xD;
&#xD;
          -  Subject has been treated with an investigational drug within 30 days or 5 half-lives&#xD;
             (whichever is longer) prior to baseline visit.&#xD;
&#xD;
          -  Patients with severe, progressive, or uncontrolled medical or psychiatric disease.&#xD;
&#xD;
          -  Concomitant therapy with medications that are strong cytochrome P450 inducers,&#xD;
             including rifampin, phenobarbital, carbamazepine, or phenytoin&#xD;
&#xD;
          -  Any other dermatologic conditions that prohibit or confound the ability of the&#xD;
             investigator to interpret skin and/or nail exam findings.&#xD;
&#xD;
          -  Patients who will be unable to avoid the use of systemic steroids, excluding&#xD;
             intranasal or inhaled steroids that will be permitted, for the duration of the trial&#xD;
&#xD;
          -  Any known hypersensitivity to apremilast&#xD;
&#xD;
          -  Any subject who, in the opinion of the investigator, will be uncooperative or unable&#xD;
             to comply with duty procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Kirklin Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>June 30, 2021</results_first_submitted>
  <results_first_submitted_qc>June 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2021</results_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Boni Elewski</investigator_full_name>
    <investigator_title>Professor, Chairman</investigator_title>
  </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>January 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03022617/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Group</title>
          <description>Open-label drug administration group. No comparator.&#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="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group</title>
          <description>Open-label drug administration group. No comparator.&#xD;
Apremilast</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.</title>
        <description>mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
        <time_frame>36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Open-label drug administration group. No comparator.&#xD;
Apremilast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.</title>
          <description>mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
          <units>percentage of reduction in mNAPSI score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.1" lower_limit="46.5" upper_limit="81.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.5</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.89</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.</title>
        <description>The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
        <time_frame>12, 24, 36, 48, and 52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving mNAPSI of 0 in All Fingernails at Weeks 36 and 52.</title>
        <description>mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
        <time_frame>36 and 52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.</title>
        <description>Nail pain VAS is a subjective survey completed by patients. Scores range from 0 to 10.</description>
        <time_frame>52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Change in Psoriatic Arthritis Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.</title>
        <description>Symptoms will be assessed using a visual analogue scale (VAS) for reporting psoriatic arthritis pain, which is a subjective survey that patients will complete on a scale of 1 to 10.</description>
        <time_frame>52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Adverse Effects Will be Assessed at Each Visit</title>
        <description>Patients will be asked about illnesses and other health related events while taking part in the study.</description>
        <time_frame>52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving a mNAPSI 75 Response, as Defined by 75% or Greater Reduction Over Baseline in mNAPSI Score at Weeks 12, 24, 36, 48, and 52 for the Target Fingernail.</title>
        <description>The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)</description>
        <time_frame>12, 24, 36, 48, and 52 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in the Total Number of Nails Involved Assessed at Weeks 36 and 52 Compared to Baseline.</title>
        <description>Health care providers to assess number of nails involved.</description>
        <time_frame>36 and 52 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over the entirety of the study, 52 weeks for each participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Group</title>
          <description>Open-label drug administration group. No comparator.&#xD;
Apremilast</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="6" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Eye Vision Loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>acute gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Emesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Increased Bowel Movements</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Salmonella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Worsened Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Psoriasis Flare</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Wrist Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </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>Dr. Boni Elewski</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>205-502-9960</phone>
      <email>dermresearch@uabmc.edu</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/NCT03022617
org study id: IRB-160720004
nct id: NCT03022617
lead sponsor: 
collaborator: 
has dmc: No
Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red
      itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the
      finger and toe nails. The most characteristic nail findings associated with nail psoriasis
      are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis
      causes a substantial disease burden for patients, it is critical that safe and effective
      treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is
      often difficult to treat.

      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that
      is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown
      promising results for treating psoriatic arthritis and nail disease; however more data is
      needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that
      apremilast will prove to be highly effective in treating nail psoriasis. We propose to
      conduct an open label clinical trial to investigate the efficacy and tolerability of
      apremilast in treating nail psoriasis, where we will follow the package insert guidelines for
      treating patients with apremilast.
Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red
      itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the
      finger and toe nails. Nail psoriasis is a chronic disease and can present with the following
      clinical findings: splinter hemorrhage, leukonychia, red spots in the lunula, nail pitting,
      nail plate crumbling, hyperkeratosis, and/or nail plate separation from the nail bed. The
      most characteristic nail findings associated with nail psoriasis are nail pitting,
      onycholysis with a rim of erythema, and oil spots. Special interest will be paid to
      identifying these particular nail findings in patients, however all potential nail psoriasis
      symptoms will be assessed in patients in this study. Due to the highly visible nature of
      disease in the fingernails, nail psoriasis often results in a substantial deleterious effect
      on a patient's quality of life. Patients also can have significant pain and disability due to
      nail psoriasis.

      Psoriasis patients who have nail involvement are known to have more severe psoriasis disease
      and diminished quality of life when compared to psoriasis patients without nail disease.
      Patients with nail psoriasis often also have psoriatic arthritis, and untreated psoriatic
      arthritis is known to lead to joint destruction with potentially severe morbidity. Nail
      psoriasis has a reported incidence of 80 to 90% (Jiaravuthiasan, et al). Because nail
      psoriasis causes a substantial disease burden for patients, it is critical that safe and
      effective treatments are found for this specific type of psoriasis. Unfortunately, nail
      psoriasis is often difficult to treat.

      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that
      is FDA approved for the treatment of psoriasis and psoriatic arthritis. PDE4 is one of the
      main phosphodiesterases expressed in immune cells, and its inhibition by apremilast is
      thought to increase cyclic adenosine monophosphate and thereby decrease the inflammatory
      response. Specifically, apremilast is believed to down regulate pro-inflammatory cytokines
      including TNF-α, (Tumor necrosis Factor) IL-23 (Interleukin), IL-17, and others.

      Apremilast has shown promising results for treating psoriatic arthritis and nail disease;
      however more data is needed regarding its effect on nail psoriasis (Kavanaugh, et al). We
      hypothesize that apremilast will prove to be highly effective in treating nail psoriasis. We
      propose to conduct an open label clinical trial to investigate the efficacy and tolerability
      of apremilast in treating nail psoriasis, where we will follow the package insert guidelines
      for treating patients with apremilast.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.
time frame: 36 weeks
description: mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)
measure: Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.
time frame: 12, 24, 36, 48, and 52 weeks
description: The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)
measure: Proportion of Patients Achieving mNAPSI of 0 in All Fingernails at Weeks 36 and 52.
time frame: 36 and 52 weeks
description: mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)
measure: Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.
time frame: 52 weeks
description: Nail pain VAS is a subjective survey completed by patients. Scores range from 0 to 10.
measure: Pain Change in Psoriatic Arthritis Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.
time frame: 52 weeks
description: Symptoms will be assessed using a visual analogue scale (VAS) for reporting psoriatic arthritis pain, which is a subjective survey that patients will complete on a scale of 1 to 10.
measure: Safety Adverse Effects Will be Assessed at Each Visit
time frame: 52 weeks
description: Patients will be asked about illnesses and other health related events while taking part in the study.
measure: Proportion of Patients Achieving a mNAPSI 75 Response, as Defined by 75% or Greater Reduction Over Baseline in mNAPSI Score at Weeks 12, 24, 36, 48, and 52 for the Target Fingernail.
time frame: 12, 24, 36, 48, and 52 weeks
description: The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)
measure: Mean Change in the Total Number of Nails Involved Assessed at Weeks 36 and 52 Compared to Baseline.
time frame: 36 and 52 weeks
description: Health care providers to assess number of nails involved.
arm group label: Study Group
arm group type: Experimental
description: Open-label drug administration group. No comparator.
intervention type: Drug
intervention name: Apremilast
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Boni Elewski
investigator title: Professor, Chairman
mesh term: Psoriasis
mesh term: Apremilast
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 