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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Biological: placebo; Biological: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468233

2011-003406-24 (EudraCT Number)

M11-810

Details and patient eligibility

About

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

Full description

The clinical trial identifier is PIONEER II. 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 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 24 weeks.

Enrollment: 326 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults must have a diagnosis of 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 total AN count of greater than or equal to 3 at baseline.

Exclusion criteria

• Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).

• Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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326 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for 12 weeks.

Treatment:

Biological: placebo

Adalimumab Every Week (EW)

Experimental group

Description:

Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).

Treatment:

Biological: adalimumab

Placebo/Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Treatment:

Biological: placebo

Adalimumab Every Week (EW)/Placebo

Experimental group

Description:

Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Treatment:

Biological: placebo

Biological: adalimumab

Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)

Experimental group

Description:

Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).

Treatment:

Biological: adalimumab

Adalimumab Every Week (EW)/Adalimumab Every Week (EW)

Experimental group

Description:

Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Treatment:

Biological: adalimumab