Abbott initiates two Phase 3 clinical trials on Humira

HS 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.

A practicing physician in Miami, Francisco Kerdel said this investigation of adalimumab in HS patients is potentially a significant step for this underserved patient population.

The 36-week, multinational, randomized, double-blind, placebo-controlled Phase 3 trials (M11-313 and M11-810) are designed to evaluate clinical outcomes and safety of adalimumab in approximately 600 patients with moderate to severe HS.

The studies will be conducted at approximately 50 sites across the world, including sites in the US, Australia, Canada and Europe.

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 have been considered for the trials.

Abbott Clinical Development, Immunology divisional vice president John Medich said 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.

"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," Medich said.