Clinical trial NCT01468233: Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
Official title: A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hidradenitis Suppurativa (HS)
Keywords: placebo controlled
double blind
adalimumab
TNF
psoriasis
HS
PIONEER II
hidradenitis suppurativa
acne inversa
boil
acne
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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).
* 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).

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Baseline (Week 0) up to Week 12
Secondary outcomes:
measure: Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
timeFrame: Baseline (Week 0) up to Week 12
measure: Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3
timeFrame: Baseline (Week 0) up to Week 12
measure: Change From Baseline to Week 12 in Modified Sartorius Score
timeFrame: Baseline (Week 0) and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Martin Okun, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.