Clinical Trial Review openaccess articles

August 2016 | Volume 15 | Issue 8 | Feature | 1033 | Copyright © 2016

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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, Cellular, and Imaging Markers of Arthritis in Psoriasis Patients

Psoriatic arthritis (PsA), an inflammatory arthritis associated with psoriasis, affects approximately 650,000 adults in the United States and is associated with increased morbidity and mortality. Joint inflammation and damage arise within the first 2 years of disease in 50% of patients, who manifest bone erosions and joint space narrowing on plain x-rays.

The events that underlie the conversion from psoriasis to PsA are not well understood. This conversion occurs 30% of the time within the first 10 years of psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in psoriasis patients and provide a better understanding of the underlying molecular pathogenesis that may lead to development of new therapeutic targets in PsA.

The advent of tumor necrosis factor antagonists for treatment of PsA has dramatically improved clinical response and slowed bone and cartilage degradation. Nevertheless, up to 45% of patients do not meet primary endpoints in clinical trials, which underscores the need for new therapeutic options. The researchers’ long-term goals are to: 1) develop arthritis biomarkers in psoriasis patients that will facilitate early treatment interventions; and 2) identify new therapeutic targets in PsA through better understanding the underlying molecular pathogenesis.

table 1

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 I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized antibody dependent cell cytotoxicity 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 will evaluate in 2 parts the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single IV doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (Part A, delayed type hypersensitivity [DTH] cohorts) and patients with plaque psoriasis (Part B).

The inclusion of DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as investigate systemic biomarkers, will provide useful information prior to conducting studies in other immune-inflammatory diseases, which will 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, which will be important for designing future studies in immuno-inflammatory diseases, including psoriasis. Approximately 63 subjects will be enrolled to complete dosing and critical assessments. The subject numbers will be split to approximately 31 healthy subjects (Part A) and 32 patients with psoriasis (Part B).

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ONYCHOMYCOSIS

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

The purpose of this multicenter, randomized, double-blind, parallel, vehicle-controlled study is to evaluate the efficacy and safety of P-3058 10% nail solution as a safe and effective treatment for onychomycosis. Complete cure of the target great toenail is defined as negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes, and target nail

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