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Vascular Inflammation in Psoriasis - Apremilast | Clinical Trials | Clareo Health

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Vascular Inflammation in Psoriasis - Apremilast

A Phase IV, Open Label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic Function in Psoriasis

NCT03082729•University of Pennsylvania

View on ClinicalTrials.gov

Summary

The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.

Detailed Description

The primary objectives of this study are to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis. Fluorodeoxyglucose (FDG) - positron emission tomography (PET)/computed tomography (CT) will be used to assess vascular inflammation, with multi-volumetric product, tissue-to-background ratio and total atherosclerotic burden, and body composition via volumetric quantification. This is a year-long, single arm, open label study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females 18 years of age and older.
•Clinical diagnosis of psoriasis for at least 6 months as determined by medical history interview and confirmation of diagnosis through physical examination by Investigator.
•Stable plaque psoriasis for at least 2 months before screening and at baseline (Week 0) as determined by medical history interview.
•Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the baseline (Week 0) visit.
•Psoriasis Area and Severity Index (PASI) score of ≥ 12 at the Baseline (Week 0) visit.
•Participant is a candidate for systemic therapy and has active psoriasis despite prior treatment with topical agents.
•Women are eligible to participate in the study if they meet one of the following criteria:
•Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. Women of childbearing potential must undergo periodic pregnancy testing during the study and agree to use at least one of the following methods of contraception throughout the study duration and for at least 28 days after taking the last dose of investigational product:
•Oral contraceptives
•Transdermal contraceptives
+12 more criteria

Exclusion Criteria

•Prior treatment with apremilast.
•Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
•Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
•Cannot avoid topical prescription medications for psoriasis for at least 14 days prior to the baseline visit (week 0) and during the study, with the exception of hydrocortisone 2.5% for the face and intertriginous areas.
•Cannot avoid ultraviolet B (UVB) phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.
•Cannot avoid psoralen-ultraviolet A (UVA) phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.
•Use of systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
•Systemic therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.
•All biologics, except interleukin (IL)-12/IL-23 antagonists, must be discontinued for at least 90 days prior to Baseline (Week 0).
•Any IL-12/IL-23 antagonist (e.g., ustekinumab, briakinumab) must be discontinued for at least 180 days prior to Baseline (Week 0).
+27 more criteria

Locations (7)

University of Southern California

Los Angeles, California, United States

Derm Associates, P.C.

Rockville, Maryland, United States

Buffalo Medical Group, P.C.

Buffalo, New York, United States

Oregon Medical Research Center

Portland, Oregon, United States

Dermatology and Skin Surgery Center

Exton, Pennsylvania, United States

The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Center for Clinical Studies

Houston, Texas, United States

Key Dates

Start Date

April 24, 2017

Primary Completion Date

August 17, 2021

Completion Date

August 17, 2021

Last Updated

November 10, 2022

Enrollment

ACTUAL participants

Conditions

PsoriasisCardiovascular Diseases

Interventions

Apremilast

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vascular Inflammation in Psoriasis - Apremilast

Inclusion Criteria

Exclusion Criteria

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