Clinical Trial Review openaccess articles

December 2015 | Volume 14 | Issue 12 | Feature | 1488 | Copyright © 2015

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Abstract

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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PSORIASIS

Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis

Psoriasis patients are known to be at increased risk for heart disease. This may be due to the increased prevalence of cardiovascular disease risk factors in this population, including high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are known to be altered in psoriasis, most studies have used standard lipid profiles to measure cholesterol. These tests indirectly measure low-density lipoprotein (LDL), which is bad cholesterol, and they become less accurate when triglyceride levels are high, as often seen in individuals with psoriasis. This case-control study uses a more specific and detailed cholesterol test to measure serum lipid levels in psoriasis patients, allowing for a more accurate determination of LDL and better assessment of the lipid-contribution to cardiovascular risk. It also measures other markers of inflammation that may contribute to cardiovascular disease. Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.

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PSORIASIS

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of an Intravenous Dose of GSK2831781 in Healthy Subjects and Patients With Plaque Psoriasis

This study is a phase 1, randomised, double blind (sponsor unblinded), placebo-controlled, single-ascending dose study of GSK2831781 administered intravenously. GSK2831781 is a humanized cell-mediated cytotoxicity effector-enhanced monoclonal afucosylated antibody that is specific to the lymphocyte activation gene-3 (LAG-3) protein.

This is the first administration of GSK2831781 in humans, and the study will evaluate in 2 parts the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single intravenous (IV) doses of GSK2831781 administered to 31 healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (delayed-type hypersensitivity [DTH] cohorts) and 32 patients with plaque psoriasis.

The inclusion of both DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as to investigate systemic biomarkers, will provide useful information prior to conducting studies in other immune-inflammatory diseases that involve more invasive tissue biopsies. Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from tuberculin purified protein derivative skin challenge and lesional skin biopsies from patients with psoriasis will be helpful in understanding the dose response relationship.

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MELANOMA

Immunotherapy Study for Patients With Stage IV Melanoma

According to statistics of the American Cancer Society, an estimated 73,800 individuals will be diagnosed with melanoma and 9,900 will die of the disease in 2015 in the Unites States despite current therapy. The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone or in combination with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. The hypothesis is that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, and significant prolongation of progression- free, disease-free, or overall survival, compared with the use of immune checkpoint inhibitors alone.

The expression of the murine (1,3) galactosyltransferase [alpha( 1,3)GT] gene results in the cell surface expression of (1,3) galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man. Human hosts often have pre-existing anti-alpha-gal antibodies that

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