Abbott announces patient enrollment in two phase 3 studies of HUMIRA® (adalimumab)
Abbott 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.
“Treating hidradenitis suppurativa has remained a challenge for specialists and patients, since there is no EMA-approved therapy available,” said Gregor Jemec, M.D., professor and chairman, Department of Dermatology, University of Copenhagen, Roskilde Hospital. “This investigation of adalimumab in HS patients is potentially a significant step for this underserved patient population.”
The Phase 3 trials (M11-313 and M11-810) are 36-week, multinational, randomised, 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 moderate to severe HS. At baseline, subjects must have a total abscess and inflammatory nodule count of greater than or equal to three.
“Ten years ago, HUMIRA was approved for moderate to severe rheumatoid arthritis and since then has achieved five additional indications to treat millions of patients across a range of immune diseases,” said John Medich, Ph.D., divisional vice president, Clinical Development, Immunology, Abbott. “Abbott is committed to investigating adalimumab as a treatment option for patients with hidradenitis suppurativa, and these studies represent another important step in continuing this exploration.”
Results of these Phase 3 trials are expected in 2013. More information on the trials is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233).