Date: 2014-09-30
Type of information: Initiation of patient enrollment
phase: 2
Announcement: initiation of patient enrollment
Company: Xoma (USA - CA) Laboratoires Servier (France)
Product: gevokizumab
Action
mechanism: 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.
Disease: Behcet\'s disease uveitis
Therapeutic area: Rare diseases - Ophtalmological diseases - Inflammatory diseases
Country: USA
Trial
details: The study is titled \"A RandomizEd-Withdrawal, Double-Masked, Placebo-Controlled StudY of the Efficacy and Safety of GevokizUmAb in TReating Subjects with Behcet\'sDisease UveitiS\" (EYEGUARD-US). Up to 28 patients will receive gevokizumab on an open-label basis to determine if they respond to therapy. At Day 28, those who respond to gevokizumab will be randomized, one to one, in a double-masked fashion to either gevokizumab 60 mg or placebo, dosed subcutaneously once monthly. The study\'s primary endpoint is the time to first ocular exacerbation following randomization. EYEGUARD-US is part of 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-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye in EYEGUARD-A, to prevent disease flares in patients with Behcet\'s disease uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids in EYEGUARD-C.
Latest
news: * On September 30, 2014, Xoma Corporation announced that its EYEGUARD-US supplemental clinical study is open for enrollment to patients at study sites located in the United States. The objective of this trial is to assess the efficacy and safety of gevokizumab in treating Behcet\'s disease uveitis. \"Opening EYEGUARD-US is a crucial step in our strategy to pursue Behcet\'s disease uveitis as our first indication for gevokizumab in the U.S.,\" commented John Varian, Chief Executive Officer of XOMA. \"This strategy makes us less dependent on our EYEGUARD-A and C studies in the broader non-infectious uveitis population, which continue to enroll more slowly than hoped. EYEGUARD-US is designed as a well-controlled study to supplement data from the Phase 3 EYEGUARD-B study being performed by our partner SERVIER outside the U.S. and the ex-U.S. data previously generated from two Phase 2 trials of Behcet\'s disease uveitis patients.\"
