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
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: NCT01468207

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 48803
Birmingham, Alabama, United States, 35205
United States, California
Site Reference ID/Investigator# 48804
Bakersfield, California, United States, 93309
Site Reference ID/Investigator# 80433
Encino, California, United States, 91436
Site Reference ID/Investigator# 59680
Mather, California, United States, 95655
United States, Colorado
Site Reference ID/Investigator# 56188
Colorado Springs, Colorado, United States, 80915
United States, Florida
Site Reference ID/Investigator# 57622
Dunedin, Florida, United States, 34698
Site Reference ID/Investigator# 56117
Jacksonville, Florida, United States, 32204
Site Reference ID/Investigator# 56119
Miami, Florida, United States, 33136
United States, Georgia
Site Reference ID/Investigator# 48809
Atlanta, Georgia, United States, 30327
Site Reference ID/Investigator# 89858
Macon, Georgia, United States, 31217
Site Reference ID/Investigator# 56147
Newnan, Georgia, United States, 30263
United States, Illinois
Site Reference ID/Investigator# 56084
Champaign, Illinois, United States, 61820
United States, Massachusetts
Site Reference ID/Investigator# 48807
Boston, Massachusetts, United States, 02114
United States, Michigan
Site Reference ID/Investigator# 59687
Clinton Township, Michigan, United States, 48038
Site Reference ID/Investigator# 56106
Fort Gratiot, Michigan, United States, 48059
Site Reference ID/Investigator# 56187
Grand Blanc, Michigan, United States, 48439
Site Reference ID/Investigator# 56183
Troy, Michigan, United States, 48084
United States, Minnesota
Site Reference ID/Investigator# 56118
Fridley, Minnesota, United States, 55432
United States, New Jersey
Site Reference ID/Investigator# 56184
Verona, New Jersey, United States, 07044
United States, New York
Site Reference ID/Investigator# 56082
Bronx, New York, United States, 10467
United States, North Carolina
Site Reference ID/Investigator# 56116
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Site Reference ID/Investigator# 56129
Cleveland, Ohio, United States, 44106
Site Reference ID/Investigator# 56191
Gahanna, Ohio, United States, 43230
United States, Pennsylvania
Site Reference ID/Investigator# 48802
Hershey, Pennsylvania, United States, 17033
United States, Texas
Site Reference ID/Investigator# 59681
San Antonio, Texas, United States, 78229
Australia
Site Reference ID/Investigator# 76013
Adelaide, Australia, 5000
Site Reference ID/Investigator# 71213
Brisbane, Australia, 4102
Site Reference ID/Investigator# 70773
Westmead, Australia, 2145
Canada
Site Reference ID/Investigator# 60286
Markham, Canada, L3P 1A8
Site Reference ID/Investigator# 60287
Quebec City, Canada, G1V 4X7
Site Reference ID/Investigator# 60285
St. John's, Canada, A1C 2H5
Site Reference ID/Investigator# 80333
St. John's, Canada, A1A 5E8
Site Reference ID/Investigator# 60682
Winnipeg, Canada, R3C 0N2
Czech Republic
Site Reference ID/Investigator# 66902
Hradec Kralove, Czech Republic, 50005
Site Reference ID/Investigator# 63665
Plzen-Bory, Czech Republic, 30599
Site Reference ID/Investigator# 61906
Prague 10, Czech Republic, 10034
Site Reference ID/Investigator# 60063
Prague 2, Czech Republic, 128 08
Site Reference ID/Investigator# 62623
Usti nad Labem, Czech Republic, 40113
Germany
Site Reference ID/Investigator# 60064
Berlin, Germany, 10117
Site Reference ID/Investigator# 60062
Bochum, Germany, 44791
Site Reference ID/Investigator# 63664
Darmstadt-Eberstadt, Germany, 64297
Site Reference ID/Investigator# 60066
Dessau-Rosslau, Germany, 06847
Site Reference ID/Investigator# 64463
Erlangen, Germany, 91054
Site Reference ID/Investigator# 69622
Kiel, Germany, 24105
Site Reference ID/Investigator# 60065
Mainz, Germany, 55131
Hungary
Site Reference ID/Investigator# 66533
Budapest, Hungary, 1085
Site Reference ID/Investigator# 66532
Miskolc, Hungary, 3529
Site Reference ID/Investigator# 60078
Szeged, Hungary, 6720
Site Reference ID/Investigator# 60077
Szombathely, Hungary, 9700
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
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 20, 2014