<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/NCT02251678</url>
  </required_header>
  <id_info>
    <org_study_id>EL-1005-01-01</org_study_id>
    <nct_id>NCT02251678</nct_id>
  </id_info>
  <brief_title>Evaluate the Effect of Elimune Capsules</brief_title>
  <official_title>Open-Label Study to Evaluate the Effect of Elimune Capsules on Biomarkers in Patients With Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elorac, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elorac, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein&#xD;
      (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),&#xD;
      Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.&#xD;
&#xD;
      Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with&#xD;
      triggering factors such as trauma, inflammation or medication.&#xD;
&#xD;
      Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.&#xD;
      Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,&#xD;
      Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,&#xD;
      Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability&#xD;
      to inhibit tumor necrosis factor-α (TNF-α).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label study consisting of a 1 day Screening Period and a 28 day Treatment&#xD;
      Period. During the Screening Period subjects will sign informed consent and eligibility will&#xD;
      be determined by reviewing inclusion/exclusion criteria including history of plaque&#xD;
      psoriasis. Demographics, medical history, medication history, height and weight will be&#xD;
      recorded. A blood sample for pre-dose biomarker analysis will be collected. Subjects will&#xD;
      take two Elimune capsules twice daily from Day 1 to Day 28. On Day 7 and Day 28 subjects will&#xD;
      return to the site and provide a blood sample for biomarker analysis. Adverse events and&#xD;
      concomitant medications will be recorded throughout the study. A Physician's Evaluation of&#xD;
      Plaque Severity and Physician's Evaluation of Arthritis Severity will be performed on Day 1,&#xD;
      Day 7, and Day 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Individual subject serum levels of biomarkers</measure>
    <time_frame>28 Days</time_frame>
    <description>C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician's Evaluation of Plaque Severity</measure>
    <time_frame>28 Days</time_frame>
    <description>Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's Evaluation of Arthritis Severity</measure>
    <time_frame>28 Days</time_frame>
    <description>Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Elimune capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elimune capsules 2 capsules BID (four total capsules per day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Elimune Capsules</intervention_name>
    <description>2 capsules BID for 28 days</description>
    <arm_group_label>Elimune capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject voluntarily agrees to participate in this study and signs an IRB-approved&#xD;
             informed consent prior to performing any of the screening procedures.&#xD;
&#xD;
          2. Males and females at least 18 years of age.&#xD;
&#xD;
          3. Except for plaque psoriasis with or without arthritis, subject is in generally good&#xD;
             health.&#xD;
&#xD;
          4. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (&gt;&#xD;
             5% BSA) with or without arthritis.&#xD;
&#xD;
          5. Non-pregnant, non-lactating females of childbearing potential who agree to use&#xD;
             medically acceptable forms of birth control (abstinence, hormonal contraceptives,&#xD;
             diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout&#xD;
             the study or females of non-childbearing potential (surgically sterile [hysterectomy&#xD;
             or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy&#xD;
             test must be confirmed at screening for all female subjects who are not surgically&#xD;
             sterile.&#xD;
&#xD;
          6. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the&#xD;
             past year).&#xD;
&#xD;
          7. Subject is willing and able to cooperate to the extent required by the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide,&#xD;
             Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and&#xD;
             Hesperetin.&#xD;
&#xD;
          2. Subject has history of alcohol and/or illicit drug abuse.&#xD;
&#xD;
          3. Female subjects who are pregnant or breastfeeding.&#xD;
&#xD;
          4. History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira)&#xD;
             within 12 months of Day 1.&#xD;
&#xD;
          5. Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or&#xD;
             Soriatane for 90 Days prior to Day 1 and throughout the trial.&#xD;
&#xD;
          6. Use of over the counter (OTC) medications (including vitamins), prescription&#xD;
             medications, or herbal remedies that have not been stable for 30 days prior to Day 1&#xD;
             or will not be stable throughout the study.&#xD;
&#xD;
          7. Use of an investigational drug within 90 days prior to Day 1.&#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>Scott B. Phillips, MD</last_name>
    <role>Study Director</role>
    <affiliation>Elorac, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMFF Dermatology Clinic</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NM Lake Forest Hospital/ Women's Center</name>
      <address>
        <city>Lake Forest</city>
        <state>Illinois</state>
        <zip>60045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TKL Research</name>
      <address>
        <city>Fair Lawn</city>
        <state>New Jersey</state>
        <zip>07410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center / Dept of Dermatology</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>December 7, 2015</last_update_submitted>
  <last_update_submitted_qc>December 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plaque</keyword>
  <keyword>Psoriasis</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>CRP</keyword>
  <keyword>αTNF</keyword>
  <keyword>Interleuken</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02251678
org study id: EL-1005-01-01
nct id: NCT02251678
lead sponsor: 
has dmc: No
Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein
      (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),
      Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.

      Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with
      triggering factors such as trauma, inflammation or medication.

      Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.
      Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,
      Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,
      Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability
      to inhibit tumor necrosis factor-α (TNF-α).
This is an open-label study consisting of a 1 day Screening Period and a 28 day Treatment
      Period. During the Screening Period subjects will sign informed consent and eligibility will
      be determined by reviewing inclusion/exclusion criteria including history of plaque
      psoriasis. Demographics, medical history, medication history, height and weight will be
      recorded. A blood sample for pre-dose biomarker analysis will be collected. Subjects will
      take two Elimune capsules twice daily from Day 1 to Day 28. On Day 7 and Day 28 subjects will
      return to the site and provide a blood sample for biomarker analysis. Adverse events and
      concomitant medications will be recorded throughout the study. A Physician's Evaluation of
      Plaque Severity and Physician's Evaluation of Arthritis Severity will be performed on Day 1,
      Day 7, and Day 28.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Individual subject serum levels of biomarkers
time frame: 28 Days
description: C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)
measure: Physician's Evaluation of Plaque Severity
time frame: 28 Days
description: Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).
measure: Physician's Evaluation of Arthritis Severity
time frame: 28 Days
description: Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).
arm group label: Elimune capsules
arm group type: Experimental
description: Elimune capsules 2 capsules BID (four total capsules per day)
intervention type: Dietary Supplement
intervention name: Elimune Capsules
description: 2 capsules BID for 28 days
arm group label: Elimune capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott B. Phillips, MD
role: Study Director
affiliation: Elorac, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis