Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

HS is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.

Inclusion Criteria:

• Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:

  1. Completed the study; or

  2. Experienced a loss of response (LOR); or

  3. Experienced worsening or absence of improvement

     Exclusion Criteria:

• Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.

• Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.

• Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.