Phase 3 Trials launching for adalimumab for hidradenitis suppurativa

March 15, 2012

Two Phase 3 clinical trials are underway to evaluate the safety and efficacy of Abbott's Humira (adalimumab) in adult patients with moderate to severe hidradenitis suppurativa (HS). The 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. They will be conducted at approximately 50 sites worldwide, including sites in Australia, Canada, Europe and the United States. 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.

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