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Autorizac. para la F. III de ensayos con gevokizumab (Europa

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Trial to test safety, efficacy of gevokizumab in patients with Behçet’s uveitis

Servier has received authorization to initiate a phase 3 clinical trial in several European countries to analyze the efficacy and safety of gevokizumab compared with placebo in reducing the risk of uveitis exacerbations in Behçet’s disease, according to a press release from Servier partner XOMA.

The EYEGUARD-B trial will enroll 110 patients with a history of Behçet’s disease uveitis. Patients will receive either a 60-mg dose of gevokizumab or placebo administered subcutaneously every 4 weeks in addition to their current immunosuppressive and corticosteroid therapies, the release said.

The study’s primary endpoint will be the time to first acute ocular exacerbation, to be measured after a predetermined number of exacerbations have been observed.

Gevokizumab is a monoclonal antibody with allosteric modulating properties, according to the release. It binds to interleukin-1 beta, a pro-inflammatory cytokine that is related to Behçet’s disease, along with other forms of noninfectious uveitis, cardiovascular disease and other auto-inflammatory diseases.

The U.S. Food and Drug Administration has granted orphan drug designation to gevokizumab for treatment of noninfectious intermediate uveitis, posterior uveitis or panuveitis or chronic noninfectious anterior uveitis, the release said.

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