Evaluate the Effect of Elimune Capsules

Open-Label Study to Evaluate the Effect of Elimune Capsules on Biomarkers in Patients With Plaque Psoriasis

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).

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Dietary supplement: Elimune Capsules

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • NMFF Dermatology Clinic
    • Lake Forest, Illinois, United States, 60045
      • NM Lake Forest Hospital/ Women's Center
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center / Dept of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
2. Males and females at least 18 years of age.
3. Except for plaque psoriasis with or without arthritis, subject is in generally good health.
4. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (> 5% BSA) with or without arthritis.
5. Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at screening for all female subjects who are not surgically sterile.
6. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year).
7. Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

1. Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and Hesperetin.
2. Subject has history of alcohol and/or illicit drug abuse.
3. Female subjects who are pregnant or breastfeeding.
4. History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira) within 12 months of Day 1.
5. Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or Soriatane for 90 Days prior to Day 1 and throughout the trial.
6. Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies that have not been stable for 30 days prior to Day 1 or will not be stable throughout the study.
7. Use of an investigational drug within 90 days prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elimune capsules; Elimune capsules 2 capsules BID (four total capsules per day)	Dietary supplement: Elimune Capsules; 2 capsules BID for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual subject serum levels of biomarkers	C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Evaluation of Plaque Severity	Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).	28 Days
Physician's Evaluation of Arthritis Severity	Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).	28 Days

Collaborators and Investigators

• Sponsor: Elorac, Inc.
• Investigators: Study Director: Scott B. Phillips, MD, Elorac, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Psoriasis; Biomarkers; Plaque; CRP; αTNF; Interleuken
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: EL-1005-01-01