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Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hidradenitis Suppurativa (HS)

Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
David Williams, MD, Study Chair, Affiliation: AbbVie

Summary

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

Clinical Details

Official title: A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER I

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Proportion of subjects achieving clinical response at Week 12

Secondary outcome:

Proportion of subjects achieving counts of 0, 1, or 2 at Week 12

Reduction in patient skin pain assessment at Week 12

Change in Sartorius scale

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Site Reference ID/Investigator# 76013, Adelaide 5000, Australia

Site Reference ID/Investigator# 71213, Brisbane 4102, Australia

Site Reference ID/Investigator# 70773, Westmead 2145, Australia

Site Reference ID/Investigator# 60286, Markham L3P 1A8, Canada

Site Reference ID/Investigator# 60287, Quebec City G1V 4X7, Canada

Site Reference ID/Investigator# 60285, St. John's A1C 2H5, Canada

Site Reference ID/Investigator# 80333, St. John's A1A 5E8, Canada

Site Reference ID/Investigator# 60682, Winnipeg R3C 0N2, Canada

Site Reference ID/Investigator# 66902, Hradec Kralove 50005, Czech Republic

Site Reference ID/Investigator# 63665, Plzen-Bory 30599, Czech Republic

Site Reference ID/Investigator# 61906, Prague 10 10034, Czech Republic

Site Reference ID/Investigator# 60063, Prague 2 128 08, Czech Republic

Site Reference ID/Investigator# 62623, Usti nad Labem 40113, Czech Republic

Site Reference ID/Investigator# 60064, Berlin 10117, Germany

Site Reference ID/Investigator# 60062, Bochum 44791, Germany

Site Reference ID/Investigator# 63664, Darmstadt-Eberstadt 64297, Germany

Site Reference ID/Investigator# 60066, Dessau-Rosslau 06847, Germany

Site Reference ID/Investigator# 64463, Erlangen 91054, Germany

Site Reference ID/Investigator# 69622, Kiel 24105, Germany

Site Reference ID/Investigator# 60065, Mainz 55131, Germany

Site Reference ID/Investigator# 66533, Budapest 1085, Hungary

Site Reference ID/Investigator# 66532, Miskolc 3529, Hungary

Site Reference ID/Investigator# 60078, Szeged 6720, Hungary

Site Reference ID/Investigator# 60077, Szombathely 9700, Hungary

Site Reference ID/Investigator# 48803, Birmingham, Alabama 35205, United States

Site Reference ID/Investigator# 48804, Bakersfield, California 93309, United States

Site Reference ID/Investigator# 80433, Encino, California 91436, United States

Site Reference ID/Investigator# 59680, Mather, California 95655, United States

Site Reference ID/Investigator# 56188, Colorado Springs, Colorado 80915, United States

Site Reference ID/Investigator# 57622, Dunedin, Florida 34698, United States

Site Reference ID/Investigator# 56117, Jacksonville, Florida 32204, United States

Site Reference ID/Investigator# 56119, Miami, Florida 33136, United States

Site Reference ID/Investigator# 48809, Atlanta, Georgia 30342, United States

Site Reference ID/Investigator# 89858, Macon, Georgia 31217, United States

Site Reference ID/Investigator# 56147, Newnan, Georgia 30263, United States

Site Reference ID/Investigator# 56084, Champaign, Illinois 61820, United States

Site Reference ID/Investigator# 48807, Boston, Massachusetts 02114, United States

Site Reference ID/Investigator# 59687, Clinton Township, Michigan 48038, United States

Site Reference ID/Investigator# 56106, Fort Gratiot, Michigan 48059, United States

Site Reference ID/Investigator# 56187, Grand Blanc, Michigan 48439, United States

Site Reference ID/Investigator# 56183, Troy, Michigan 48084, United States

Site Reference ID/Investigator# 56118, Fridley, Minnesota 55432, United States

Site Reference ID/Investigator# 56184, Verona, New Jersey 07044, United States

Site Reference ID/Investigator# 56082, Bronx, New York 10467, United States

Site Reference ID/Investigator# 56116, Winston-Salem, North Carolina 27157, United States

Site Reference ID/Investigator# 56129, Cleveland, Ohio 44106, United States

Site Reference ID/Investigator# 56191, Gahanna, Ohio 43230, United States

Site Reference ID/Investigator# 48802, Hershey, Pennsylvania 17033, United States

Site Reference ID/Investigator# 59681, San Antonio, Texas 78229, United States

Additional Information

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Starting date: November 2011
Last updated: January 22, 2015

Page last updated: August 23, 2015

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