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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01468233
First received: November 7, 2011
Last updated: May 8, 2014
Last verified: May 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 II

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 achieving 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: 326
Study Start Date: November 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab every week (ew)
adalimumab every week
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every week
Other Name: Humira
Placebo Comparator: placebo
placebo
Biological: placebo
Prefilled syringe, placebo every week
Other Name: placebo
Experimental: adalimumab every other week (eow)
adalimumab every other week (eow)
Biological: adalimumab
Prefilled syringe, subcutaneous every other week (eow)
Other Name: Humira

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 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 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).
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468233

  Hide Study Locations
Locations
United States, California
Site Reference ID/Investigator# 56314
San Diego, California, United States, 92122
United States, Connecticut
Site Reference ID/Investigator# 61049
Farmington, Connecticut, United States, 06030
United States, Florida
Site Reference ID/Investigator# 57623
Dunedin, Florida, United States, 34698
Site Reference ID/Investigator# 56323
Orange Park, Florida, United States, 32073-4120
Site Reference ID/Investigator# 95826
Tampa, Florida, United States, 33624
United States, Illinois
Site Reference ID/Investigator# 59704
Chicago, Illinois, United States, 60611
United States, Massachusetts
Site Reference ID/Investigator# 58902
Boston, Massachusetts, United States, 02111
Site Reference ID/Investigator# 48827
Boston, Massachusetts, United States, 02114
United States, Michigan
Site Reference ID/Investigator# 96095
Sterling Heights, Michigan, United States, 48314
United States, Nebraska
Site Reference ID/Investigator# 59203
Omaha, Nebraska, United States, 68144
United States, Nevada
Site Reference ID/Investigator# 95830
Henderson, Nevada, United States, 89074
Site Reference ID/Investigator# 95825
Henderson, Nevada, United States, 89074
United States, North Carolina
Site Reference ID/Investigator# 56317
Chapel Hill, North Carolina, United States, 27516
Site Reference ID/Investigator# 56316
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Site Reference ID/Investigator# 56305
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Site Reference ID/Investigator# 56306
Nashville, Tennessee, United States, 37215
United States, Virginia
Site Reference ID/Investigator# 48828
Norfolk, Virginia, United States, 23507
United States, Washington
Site Reference ID/Investigator# 102495
Seattle, Washington, United States, 98101
Australia
Site Reference ID/Investigator# 68063
Benowa, Australia, 4217
Site Reference ID/Investigator# 65726
Brisbane, Australia, 4102
Site Reference ID/Investigator# 65727
Carlton, Australia, 3053
Site Reference ID/Investigator# 65729
Fremantle, Australia, 6160
Site Reference ID/Investigator# 68082
Phillip, Australia, 2606
Site Reference ID/Investigator# 65723
St. Leonards, Australia, 2065
Canada
Site Reference ID/Investigator# 61865
Barrie, Canada, L4M 6L2
Site Reference ID/Investigator# 60686
Halifax, Canada, B3H 0A2
Site Reference ID/Investigator# 60290
Moncton, Canada, E1C 8X3
Site Reference ID/Investigator# 100415
Peterborough, Canada, K9J 1Z2
Site Reference ID/Investigator# 60288
Surrey, Canada, V3R 6A7
Site Reference ID/Investigator# 60687
Waterloo, Canada, N2J 1C4
Denmark
Site Reference ID/Investigator# 60088
Aarhus C, Denmark, 8000
Site Reference ID/Investigator# 60090
Copenhagen NV, Denmark, 2400
Site Reference ID/Investigator# 60089
Hellerup, Denmark, 2900
Site Reference ID/Investigator# 60091
Roskilde, Denmark, 4000
France
Site Reference ID/Investigator# 60093
Nantes Cedex 1, France, 44093
Site Reference ID/Investigator# 60092
Paris Cedex 10, France, 75475
Site Reference ID/Investigator# 62678
Pessac, France, 33604
Site Reference ID/Investigator# 62680
Poitiers Cedex, France, 86021
Site Reference ID/Investigator# 64182
Reims Cedex, France, 51090
Greece
Site Reference ID/Investigator# 60096
Athens, Greece, 16121
Site Reference ID/Investigator# 62681
Athens, Greece, 16121
Site Reference ID/Investigator# 60097
Haidari, Athens, Greece, 12462
Site Reference ID/Investigator# 62683
Thessaloniki, Greece, 54643
Netherlands
Site Reference ID/Investigator# 60100
Amsterdam, Netherlands, 1105 AZ
Site Reference ID/Investigator# 81814
Breda, Netherlands, 4818 CK
Site Reference ID/Investigator# 60101
Rotterdam, Netherlands, 3015 CA
Puerto Rico
Site Reference ID/Investigator# 58814
Carolina, Puerto Rico, 00985
Sweden
Site Reference ID/Investigator# 62382
Lund, Sweden, 22185
Site Reference ID/Investigator# 60103
Stockholm, Sweden, 17176
Switzerland
Site Reference ID/Investigator# 67605
Bern, Switzerland, 3010
Site Reference ID/Investigator# 69302
Geneva 14, Switzerland, 1211
Site Reference ID/Investigator# 67606
Lausanne, Switzerland, 1011
Site Reference ID/Investigator# 70253
St. Gallen, Switzerland, 9007
Site Reference ID/Investigator# 67603
Zurich, Switzerland, 8091
Turkey
Site Reference ID/Investigator# 60672
Ankara, Turkey, 06100
Site Reference ID/Investigator# 60670
Istanbul, Turkey, 34390
Site Reference ID/Investigator# 60671
Istanbul, Turkey, 34093
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Martin Okun, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01468233     History of Changes
Other Study ID Numbers: M11-810, 2011-003406-24
Study First Received: November 7, 2011
Last Updated: May 8, 2014
Health Authority: Australia: National Health and Medical Research Council
Canada: Health Canada
Denmark: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Turkey: Ministry of Health
United States: Food and Drug Administration
Greece: National Organization of Medicines

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

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

ClinicalTrials.gov processed this record on October 22, 2014