Date: 2014-11-04
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Xoma (USA - CA)
Product: gevokizumab
Action
mechanism: monoclonal antibody. Gevokizumab is a monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory 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 non-infectious uveitis, including Behçet\'s uveitis, cardiovascular disease, and other auto-inflammatory diseases. By 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-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye 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 in EYEGUARD-C.
Disease: pyoderma gangrenosum
Therapeutic area: Rare diseases
Country: USA
Trial
details: *The Phase 3 randomized, placebo-controlled study will enroll 58 patients with active PG to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly, in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants. The primary endpoint is complete closure of the PG target ulcer determined at Day 126 with confirmation a minimum of two weeks later at Day 140. * Xoma's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. The study is designed to evaluate the response in the first four patients and be able to make decisions to continue the study with a higher dosing regimen. Patients will be assessed on Day 28 to determine gevokizumab\'s efficacy in controlling the acute inflammatory symptoms of PG, and on Day 84 to determine gevokizumab\'s longer-term effect on skin ulcers. Both investigator and patient global assessments will be evaluated throughout the study. (NCT01882504)
Latest
news: * On November 4, 2014, Xoma announced its pivotal Phase 3 gevokizumab study in patients with active pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of expanding necrotic skin ulcers, is open for patient enrollment. The objective of the study is to assess the efficacy and safety of gevokizumab in treating the active ulcers caused by this rare and debilitating disease. The FDA granted orphan drug designation to gevokizumab for PG in February 2014. The Phase 3 randomized, placebo-controlled study will enroll 58 patients with active PG to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly, in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants. The primary endpoint is complete closure of the PG target ulcer determined at Day 126 with confirmation a minimum of two weeks later at Day 140. * On April 28, 2014, Xoma Corporation has announced that based on its meeting with the FDA, the company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum. During the meeting, Xoma and the FDA reviewed the data generated from a pilot trial in six pyoderma gangrenosum patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active pyoderma gangrenosum. Xoma is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active pyoderma gangrenosum. The primary endpoint is complete wound closure of the target ulcer at approximately four months. Xoma anticipates conducting these parallel studies in the United States and several other countries. Gevokizumab has been granted orphan drug designation by the FDA for the treatment of pyoderma gangrenosum. * On June 13, 2013, Xoma has announced it has opened enrollment in a pilot study to determine gevokizumab\'s potential to treat acute inflammatory pyoderma gangrenosum. Pyoderma gangrenosum (PG) is one of the several rare diseases that are classified under the broader cluster of neutrophilic dermatoses. Xoma\'s pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. An inflammatory episode of PG is characterized by recently developed active ulcers and ulcer-related pain. "We had previously indicated that Xoma and our partner Servier would evaluate the potential to test gevokizumab in a couple of rare disease areas, neutrophilic dermatosis and Schnitzler syndrome. Since the majority of Schnitzler patients are in Western Europe, Servier has been actively exploring the potential to pursue this indication in this orphan disease while we have been working with the experts in the neutrophilic dermatosis field to identify which subset of this rare disease class might respond best to gevokizumab. They believe acute inflammatory pyoderma gangrenosum is an ideal candidate, as a significant number of the patients tend to have an underlying inflammatory disease that results in PG\'s hallmark skin lesions,\" stated John Varian, Chief Executive Officer of Xoma.
