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Efficacy and Safety Study of Adalimumab in the 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

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):
Martin Okun, 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 II

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 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

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).

- 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).

Locations and Contacts

Site Reference ID/Investigator# 68063, Benowa 4217, Australia

Site Reference ID/Investigator# 65727, Carlton 3053, Australia

Site Reference ID/Investigator# 65729, Fremantle 6160, Australia

Site Reference ID/Investigator# 68082, Phillip 2606, Australia

Site Reference ID/Investigator# 65723, St. Leonards 2065, Australia

Site Reference ID/Investigator# 65726, Woolloongabba 4102, Australia

Site Reference ID/Investigator# 61865, Barrie L4M 6L2, Canada

Site Reference ID/Investigator# 60686, Halifax B3H 0A2, Canada

Site Reference ID/Investigator# 60290, Moncton E1C 8X3, Canada

Site Reference ID/Investigator# 100415, Peterborough K9J 1Z2, Canada

Site Reference ID/Investigator# 60288, Surrey V3V 0C6, Canada

Site Reference ID/Investigator# 60687, Waterloo N2J 1C4, Canada

Site Reference ID/Investigator# 60088, Aarhus C 8000, Denmark

Site Reference ID/Investigator# 60090, Copenhagen NV 2400, Denmark

Site Reference ID/Investigator# 60089, Hellerup 2900, Denmark

Site Reference ID/Investigator# 60091, Roskilde 4000, Denmark

Site Reference ID/Investigator# 60093, Nantes Cedex 1 44093, France

Site Reference ID/Investigator# 60092, Paris Cedex 10 75475, France

Site Reference ID/Investigator# 62678, Pessac 33604, France

Site Reference ID/Investigator# 62680, Poitiers Cedex 86021, France

Site Reference ID/Investigator# 64182, Reims Cedex 51090, France

Site Reference ID/Investigator# 60096, Athens 16121, Greece

Site Reference ID/Investigator# 62681, Athens 16121, Greece

Site Reference ID/Investigator# 60097, Haidari, Athens 12462, Greece

Site Reference ID/Investigator# 62683, Thessaloniki 54643, Greece

Site Reference ID/Investigator# 60100, Amsterdam 1105 AZ, Netherlands

Site Reference ID/Investigator# 81814, Breda 4818 CK, Netherlands

Site Reference ID/Investigator# 60101, Rotterdam 3015 CA, Netherlands

Site Reference ID/Investigator# 58814, Carolina 00985, Puerto Rico

Site Reference ID/Investigator# 62382, Lund 22185, Sweden

Site Reference ID/Investigator# 60103, Stockholm 17176, Sweden

Site Reference ID/Investigator# 67605, Bern 3010, Switzerland

Site Reference ID/Investigator# 69302, Geneva 14 1211, Switzerland

Site Reference ID/Investigator# 67606, Lausanne 1011, Switzerland

Site Reference ID/Investigator# 70253, St. Gallen 9007, Switzerland

Site Reference ID/Investigator# 67603, Zurich 8091, Switzerland

Site Reference ID/Investigator# 60672, Ankara 06100, Turkey

Site Reference ID/Investigator# 60670, Istanbul 34390, Turkey

Site Reference ID/Investigator# 60671, Istanbul 34093, Turkey

Site Reference ID/Investigator# 56314, San Diego, California 92122, United States

Site Reference ID/Investigator# 61049, Farmington, Connecticut 06032, United States

Site Reference ID/Investigator# 57623, Dunedin, Florida 34698, United States

Site Reference ID/Investigator# 56323, Orange Park, Florida 32073-4120, United States

Site Reference ID/Investigator# 95826, Tampa, Florida 33624, United States

Site Reference ID/Investigator# 59704, Chicago, Illinois 60611, United States

Site Reference ID/Investigator# 48827, Boston, Massachusetts 02114, United States

Site Reference ID/Investigator# 58902, Boston, Massachusetts 02111, United States

Site Reference ID/Investigator# 56308, Fort Gratiot, Michigan 48059, United States

Site Reference ID/Investigator# 96095, Sterling Heights, Michigan 48314, United States

Site Reference ID/Investigator# 59203, Omaha, Nebraska 68144, United States

Site Reference ID/Investigator# 95825, Henderson, Nevada 89074, United States

Site Reference ID/Investigator# 95830, Henderson, Nevada 89074, United States

Site Reference ID/Investigator# 56317, Chapel Hill, North Carolina 27516, United States

Site Reference ID/Investigator# 56316, Winston-Salem, North Carolina 27103, United States

Site Reference ID/Investigator# 56305, Pittsburgh, Pennsylvania 15213, United States

Site Reference ID/Investigator# 56306, Nashville, Tennessee 37215, United States

Site Reference ID/Investigator# 48828, Norfolk, Virginia 23507, United States

Site Reference ID/Investigator# 102495, Seattle, Washington 98101, 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: April 28, 2015

Page last updated: August 23, 2015

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