Date: 2015-04-01
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Xoma (USA - CA) Servier (France)
Product: gevokizumab
Action
mechanism: monoclonal antibody. Gevokizumab (XOMA 052/S 78989) is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory diseases and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in Behçet\\\\\\\'s and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. In binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation. Gevokizumab currently is being studied in a global Phase 3 clinical program, termed EYEGUARD™, which is being conducted by Servier and Xoma. This program is designed to determine gevokizumab\'s ability to treat acute non-anterior non-infectious uveitis (NIU) in EYEGUARD-A, to prevent disease flares in patients with Behçet\'s uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C. Servier has also initiated a Phase 2 study to determine gevokizumab's ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome in the previous twelve months.
Gevokizumab currently is in Phase 3 clinical development in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. The global development plan includes a Phase 3 trial to be conducted by Servier in patients with Behçet's uveitis.
Disease: type 2 diabetes diabetic nephropathy
Therapeutic area: Metabolic diseases - Renal diseases - Kidney diseases - Inflammatory diseases
Country:
Trial details:
Latest
news: * On April 1, 2015, Xoma announced gevokizumab will be tested in a Phase 2 study in patients with Type 2 diabetes and diabetic kidney disease, clinically referred to as diabetic nephropathy. The international, multicenter, randomized, double-blind, parallel-group, placebo-controlled study is expected to enroll 370 patients who will be randomized to receive gevokizumab or placebo for 52 weeks. The primary objective of this study is to detect the existence of an overall dose-response relationship of subcutaneously dosed gevokizumab on the measured glomerular filtration rate (mGFR), an accurate measure of kidney function, at Week 52. The study also will determine gevokizumab\'s effect on a number of biological biomarkers assessing kidney function. Servier will fully sponsor the study\'s execution and cost.
