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Evaluate the Effect of Elimune Capsules

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Elimune Capsules

About this trial

This is an interventional basic science trial for Plaque Psoriasis focused on measuring Plaque, Psoriasis, Biomarkers, CRP, αTNF, Interleuken

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
Males and females at least 18 years of age.
Except for plaque psoriasis with or without arthritis, subject is in generally good health.
Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (> 5% BSA) with or without arthritis.
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.
Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year).
Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and Hesperetin.
Subject has history of alcohol and/or illicit drug abuse.
Female subjects who are pregnant or breastfeeding.
History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira) within 12 months of Day 1.
Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or Soriatane for 90 Days prior to Day 1 and throughout the trial.
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.
Use of an investigational drug within 90 days prior to Day 1.

Sites / Locations

NMFF Dermatology Clinic
NM Lake Forest Hospital/ Women's Center
TKL Research
University Hospitals Case Medical Center / Dept of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elimune capsules

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

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).

Full Information

NCT ID

NCT02251678

First Posted

September 25, 2014

Last Updated

December 7, 2015

Sponsor

Elorac, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02251678

Brief Title

Evaluate the Effect of Elimune Capsules

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Elorac, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Plaque, Psoriasis, Biomarkers, CRP, αTNF, Interleuken

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elimune capsules

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Elimune Capsules

Intervention Description

2 capsules BID for 28 days

Primary Outcome Measure Information:

Title

Individual subject serum levels of biomarkers

Description

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 Outcome Measure Information:

Title

Physician's Evaluation of Plaque Severity

Description

Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).

Time Frame

28 Days

Title

Physician's Evaluation of Arthritis Severity

Description

Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures. Males and females at least 18 years of age. Except for plaque psoriasis with or without arthritis, subject is in generally good health. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (> 5% BSA) with or without arthritis. 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. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year). Subject is willing and able to cooperate to the extent required by the protocol. Exclusion Criteria: Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and Hesperetin. Subject has history of alcohol and/or illicit drug abuse. Female subjects who are pregnant or breastfeeding. History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira) within 12 months of Day 1. Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or Soriatane for 90 Days prior to Day 1 and throughout the trial. 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. Use of an investigational drug within 90 days prior to Day 1.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott B. Phillips, MD

Organizational Affiliation

Elorac, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

NMFF Dermatology Clinic

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

NM Lake Forest Hospital/ Women's Center

City

Lake Forest

State/Province

Illinois

ZIP/Postal Code

60045

Country

United States

Facility Name

TKL Research

City

Fair Lawn

State/Province

New Jersey

ZIP/Postal Code

07410

Country

United States

Facility Name

University Hospitals Case Medical Center / Dept of Dermatology

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

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Evaluate the Effect of Elimune Capsules

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