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
  Purpose

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


Condition Intervention Phase
Hidradenitis Suppurativa (HS)
Biological: adalimumab
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER I

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 309
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab every week (ew)
adalimumab every week (ew)
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every week
Other Name: Humira
Placebo Comparator: placebo
placebo
Biological: placebo
Prefilled syringe, placebo every week
Experimental: adalimumab every other week (eow)
adalimumab every other week (eow)
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every other week (eow)
Other Name: Humira

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468207

  Show 49 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: David Williams, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01468207     History of Changes
Other Study ID Numbers: M11-313, 2011-003400-20
Study First Received: November 7, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
Czech Republic: State Institute for Drug Control
Australia: National Health and Medical Research Council

Keywords provided by AbbVie:
acne
psoriasis
hidradenitis suppurativa
TNF
HS
PIONEER I
acne inversa
boil
placebo controlled
Double blind
adalimumab

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014