US-based therapeutic antibodies manufacturer XOMA has started patient enrolment in its EYEGUARD-US supplemental clinical trial designed to evaluate the efficacy and safety of gevokizumab in treating Behçet’s disease uveitis.
Gevokizumab is a potent monoclonal antibody that has the potential to treat patients with a wide variety of inflammatory and other diseases.
The trial is titled ‘A RandomizEd-Withdrawal, Double-Masked, Placebo-Controlled StudY of the Efficacy and Safety of GevokizUmAb in TReating Subjects with Behçet’s Disease UveitiS’ (EYEGUARD-US).
In the trial, about 28 patients will be given gevokizumab on an open-label basis to determine if they respond to therapy.
Patients, who respond to gevokizumab at day 28, will be randomised, one to one, in a double-masked manner to either gevokizumab 60mg or placebo, dosed subcutaneously once monthly.
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Primary endpoint of the trial, which will be conducted at sites in the US, is the time to first ocular exacerbation following randomisation.
XOMA senior vice-president of Research and Development and chief medical officer Dr Paul Rubin said: “To ensure we designed a study that meets the needs of the US clinicians treating patients who suffer from Behçet’s disease uveitis, we worked closely with key opinion leaders to create a protocol that reflects how they treat patients with this serious disease.
“It was important that the study design allows for the inclusion of patients experiencing active inflammatory episodes, as well as patients who are currently under control but may benefit from an alternative therapy.”
Currently, gevokizumab is being evaluated in a global Phase III clinical programme, termed EYEGUARD, which is being conducted by SERVIER and XOMA.
The programme 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 disease uveitis in EYEGUARD-B, as well as to prevent disease flares in NIU patients who are controlled with steroids in EYEGUARD-C.
XOMA chief executive officer John Varian said: “EYEGUARD-US is designed as a well-controlled study to supplement data from the Phase III EYEGUARD-B study being performed by our partner SERVIER outside the US and the ex-US data previously generated from two Phase II trials of Behçet’s disease uveitis patients.
“Upon receipt of successful results from the EYEGUARD-B study, we plan to request a pre-BLA meeting with FDA. EYEGUARD-US is designed to supplement the agency’s need for information in US patients, including potentially serving as a second pivotal study.”