Psoriasis, Psoriatic Arthritis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPEVCO
All subjects will receive PEVCO for 6 more weeks.
DIETARY_SUPPLEMENTDietary Supplement Capsules without Coconut Oil
All subjects will receive placebo (PBO) for 3 weeks
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have an active \[psoriatric plaque \>2cm
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in % of Treg Cells in Blood | 6 Weeks | % change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Medium Chain Fatty Acids (MCFA) content in the stool | 12 Weeks | Change in the amount of MCFA in stool |
| Improvement in skin disease severity PASI scores 50 | 12 Weeks | indicating 50% reduction in psoriasis |
| Improvement in skin disease severity PASI scores 75 | 12 Weeks | indicating 75% reduction in psoriasis |
| Improvement in skin disease severity PASI scores 90 | 12 Weeks | indicating 90% reduction in psoriasis |
| Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks. | 6 Weeks | To assess whether PEVCO 1000 mg four times daily for 6 weeks improves: * 66/68 Tender-joint count * 66/68 Swollen-joint count |
Countries
United States
Outcome results
None listed