Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in United States (US) and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.

Inclusion Criteria:

• Participant must have a diagnosis of HS;
• Participant must have any HS symptom at least 6 months prior to Baseline;
• HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
• Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
• Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.

Exclusion Criteria:

• Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
• Any other active skin lesion or condition that may interfere with assessment of HS;
• Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
• Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
• Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
• Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.