Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

NCT ID: NCT01468207

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-01-31

Brief Summary

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

Detailed Description

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 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.

Conditions

Hidradenitis Suppurativa (HS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Placebo pre-filled syringe, administered by subcutaneous injection

Adalimumab Every Week (EW)

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).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Placebo/Adalimumab Every Week (EW)

Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

placebo

Intervention Type: BIOLOGICAL

Placebo pre-filled syringe, administered by subcutaneous injection

Adalimumab Every Week (EW)/Placebo

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).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

placebo

Intervention Type: BIOLOGICAL

Placebo pre-filled syringe, administered by subcutaneous injection

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

Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg 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).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

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

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).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type: BIOLOGICAL

placebo

Placebo pre-filled syringe, administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira

Eligibility Criteria

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).
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Williams, MD

Role: STUDY_CHAIR

AbbVie

References

Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.

Reference Type: RESULT

PMID: 27518661 (View on PubMed)

Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.

Reference Type: DERIVED

PMID: 39141589 (View on PubMed)

Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

Reference Type: DERIVED

PMID: 29380251 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

2011-003400-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M11-313

Identifier Type: -

Identifier Source: org_study_id