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XOMA begins enrollment for phase 3 pyoderma gangrenosum study
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XOMA Corporation has announced that its phase 3 gevokizumab study in patients with active pyoderma gangrenosum is now open for enrollment.
The study, which will assess gevokizumab’s efficacy and safety in treating the active ulcers caused by the disease, follows the U.S. Food and Drug Administration orphan drug designation gevokizumab received in February 2014, according to a company press release.
The phase 3, randomized, placebo-controlled study will enroll 58 patients with active pyoderma gangrenosum who will be assigned to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly in addition to their current treatment regimen of low-dose corticosteriods and/or immunosuppressants.
The study’s primary endpoint is complete closure of the pyoderma gangrenosum target ulcer determined at day 126 with confirmation a minimum of 2 weeks later at day 140, according to the press release.