Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER I)

• Proportion of subjects achieving counts of 0, 1, or 2 at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
  Subjects counts lowered to 0, 1 or 2 at Week 12 among subjects with Hurley Stage II at Baseline.
• Reduction in patient skin pain assessment at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
  Proportion of subjects who achieve a reduction, and at least 1 unit reduction from baseline in their skin pain at measured by the Patient's Global Assessment of Skin Pain (NRS30) at Week 12
• Change in Sartorius scale [ Time Frame: Baseline (Week 0) and Week 12 ] [ Designated as safety issue: No ]
  Change in Sartorius scale from Baseline to Week 12

A study to evaluate the safety and efficacy of treatment in adults with moderate to severe hidradenitis suppurativa.

The clinical trial identifier is PIONEER I. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe hidradenitis suppurativa (HS). HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last up to 24 weeks.

• Biological: adalimumab
  Prefilled syringe, adalimumab subcutaneous every week
  Other Name: Humira
• Biological: placebo
  Prefilled syringe, placebo every week
• Biological: adalimumab
  Prefilled syringe, adalimumab subcutaneous every other week (eow)
  Other Name: Humira

• Experimental: adalimumab every week (ew)
  adalimumab every week (ew)
  Intervention: Biological: adalimumab
• Placebo Comparator: placebo
  placebo
  Intervention: Biological: placebo
• Experimental: adalimumab every other week (eow)
  adalimumab every other week (eow)
  Intervention: Biological: adalimumab

Inclusion Criteria:

• Adults must have a diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
• HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
• Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
• Subject must have experienced an inadequate response to at least a 90 day treatment of oral antibiotics for treatment of HS.
• Subject must have a count of greater than or equal to 3 at baseline.

Exclusion Criteria:

• Subject was previously treated with adalimumab or another anti-TNF therapy (e.g., infliximab or etanercept).
• Subject received any oral antibiotic treatment for HS within 28 days prior to Baseline.
• Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.

• If entering the study on concomitant oral analgesics for non-HS related pain:

  • Subject on opioid analgesics within 14 days prior to Baseline visit;
  • Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).