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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
All subjects will receive PEVCO for 6 more weeks.
All subjects will receive placebo (PBO) for 3 weeks
New York University School of Medicine
New York, New York, United States
Change in % of Treg Cells in Blood
% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.
Time frame: 6 Weeks
Increase in Medium Chain Fatty Acids (MCFA) content in the stool
Change in the amount of MCFA in stool
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 50
indicating 50% reduction in psoriasis
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 75
indicating 75% reduction in psoriasis
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 90
indicating 90% reduction in psoriasis
Time frame: 12 Weeks
Improvement in the tender joint/swollen joint (TJ/SJ) counts at 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
Time frame: 6 Weeks
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