Abbott (ABT) Initiates Two Phase 3s for HUMIRA in Adults with HS
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Abbott (NYSE: ABT) today announced the initiation of two Phase 3 clinical trials designed to evaluate the safety and efficacy of an investigational use of HUMIRA (adalimumab) in adult patients with moderate to severe hidradenitis suppurativa (HS).
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 and start out as tender, swollen bumps. Over time, these lesions can fill with fluid, burst, and result in scars. This can lead to pain and discomfort.
The Phase 3 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.
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 and start out as tender, swollen bumps. Over time, these lesions can fill with fluid, burst, and result in scars. This can lead to pain and discomfort.
The Phase 3 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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