Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Completed · Not applicable · Has a placebo group

Conditions studied: Psoriasis, Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT03409211

Run by

NYU Langone Health

People needed

22

Starts

2017-12-12

Expected to finish

2019-09-30

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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