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CompletedNCT02251678Updated Dec 8, 2015

Evaluate the Effect of Elimune Capsules

A Phase 1 interventional study of Elimune Capsules in Plaque Psoriasis, sponsored by Elorac, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-08.

Sponsored by Elorac, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Plaque Psoriasis

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Keywords

  • Plaque
  • Psoriasis
  • Biomarkers
  • CRP
  • αTNF
  • Interleuken
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 21 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Elorac, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Elimune capsules

    Elimune capsules 2 capsules BID (four total capsules per day)

    Dietary Supplement: Elimune Capsules

Interventions

  • Dietary supplementElimune Capsules

    2 capsules BID for 28 days

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 28 Days

Secondary outcomes

  1. 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).

    Time frame: 28 Days

  2. 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).

    Time frame: 28 Days

07

Study locations

4 sites
  • NMFF Dermatology Clinic
    Chicago, Illinois 60611, United States
  • NM Lake Forest Hospital/ Women's Center
    Lake Forest, Illinois 60045, United States
  • TKL Research
    Fair Lawn, New Jersey 07410, United States
  • University Hospitals Case Medical Center / Dept of Dermatology
    Cleveland, Ohio 44106, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02251678
Lead sponsor
Elorac, Inc.
Responsible party
Sponsor
First posted
Sep 29, 2014
Start date
Sep 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Dec 8, 2015

Study contacts

Scott B. Phillips, MD
study director · Elorac, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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