Humira (Abbott) in 2 Phase III trials for Hidradenitis Suppurativa
Abbott Labs announces the initiation of two Phase III clinical trials designed to evaluate the safety and efficacy of Humira(adalimumab) in adult patients with moderate to severe Hidradenitis Suppurativa (HS). The Phase III trials (M11-313 and M11-810) are 36-week, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate clinical outcomes and safety of adalimumab in approximately 600 patients with moderate to severe HS.Resuts are expected in 2013. Selected inclusion criteria include: participants who have been diagnosed with moderate to severe HS for at least one year prior to enrollment with stable disease for the last two months, lesions in two distinct areas, and have had an inadequate response to at least a three-month trial of an oral antibiotic for treatment of HS. At baseline, subjects must have a total abscess and inflammatory nodule count of greater than or equal to three. Hidradenitis suppurativa is a difficult-to-treat, chronic, inflammatory skin disease characterized by painful, recurrent abscesses, and nodules that primarily appear in the groin or under the armpits or breasts.