NCT03409211

Brief Summary

This is a proof-of-principle, placebo-controlled, open label study to assess the improvement in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients with PsO (subjects may or may not have PsA) , who have active disease and are not currently receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy subjects. The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3 weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be used during this period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

January 5, 2018

Last Update Submit

December 1, 2020

Conditions

PsoriasisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in % of Treg Cells in Blood

    % change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.

    6 Weeks

Secondary Outcomes (5)

  • Increase in Medium Chain Fatty Acids (MCFA) content in the stool

    12 Weeks

  • Improvement in skin disease severity PASI scores 50

    12 Weeks

  • Improvement in skin disease severity PASI scores 75

    12 Weeks

  • Improvement in skin disease severity PASI scores 90

    12 Weeks

  • Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.

    6 Weeks

Study Arms (2)

Pso

ACTIVE COMPARATOR

with or without PsA

Dietary Supplement: PEVCODietary Supplement: Dietary Supplement Capsules without Coconut Oil

Healthy Subjects

ACTIVE COMPARATOR

Without PsA

Dietary Supplement: PEVCODietary Supplement: Dietary Supplement Capsules without Coconut Oil

Interventions

PEVCODIETARY_SUPPLEMENT

All subjects will receive PEVCO for 6 more weeks.

Also known as: Coconut Oil
Healthy SubjectsPso
Dietary Supplement Capsules without Coconut OilDIETARY_SUPPLEMENT

All subjects will receive placebo (PBO) for 3 weeks

Healthy SubjectsPso

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an active \[psoriatric plaque \>2cm

You may not qualify if:

  • History of sensitivity to study compound or any of their excipients
  • Previous intolerance to PEVCO or related compounds
  • Current (within 3 months of screening) treatment with DMARDs
  • Current (within 3 months of screening) treatment with biologic therapies (including but limited to anti-TNF,anti-IL-17, anti-IL-12/23)
  • Current antibiotic treatment (within 3 months of screening)
  • current consumption of probiotics (within 3 months of screening)
  • Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy)
  • Renal failure (eGFR ,30 or require dialysis) by history
  • History of other autoimmune or inflammatory skin disease
  • Current immunodeficiency state (cancer, HIV, others)
  • Current immunodeficiency state (cancer, HIV, Other)
  • Concern for inability of the patient to comply with study procedure, and or follow up (alcohol or drug abuse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Interventions

Coconut OilDietary Supplements

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jose Scher, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 24, 2018

Study Start

December 12, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

US(1)