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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01468207
First received: November 7, 2011
Last updated: February 19, 2014
Last verified: February 2014

November 7, 2011
February 19, 2014
November 2011
January 2014   (final data collection date for primary outcome measure)
Proportion of subjects achieving clinical response at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
Subjects improvement in hidradenitis suppurativa severity.
Same as current
Complete list of historical versions of study NCT01468207 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER I

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hidradenitis Suppurativa (HS)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
January 2014
January 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Czech Republic,   Germany,   Hungary
 
NCT01468207
M11-313, 2011-003400-20
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Chair: David Williams, MD AbbVie
AbbVie
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP