Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa

Study Description

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Brief Summary:

The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after the medication is stopped.

Condition or disease	Intervention/treatment	Phase
Hidradenitis Suppurativa	Drug: efalizumab	Phase 1

Detailed Description:

The primary objective of this study is to assess the efficacy of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa. The secondary objectives of this study are to assess the ability to re-establish disease control after discontinuation of drug and allowance for relapse of disease, as well as to assess the safety of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	5 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Study Start Date :	February 2005
Study Completion Date :	August 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Reduction in number of inflammatory lesions 12 weeks post-baseline

Secondary Outcome Measures :

1. Time to the reduction of lesions during 12 weeks of treatment
2. Percent of disease activity at various weeks after baseline

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Female between 18-65 years of age
• Has Hydradenitis Suppurativa (HS) involving at least 1 area of the body with greater than or equal to 12 lesions; onset of disease is 6 months and greater.
• Failed at least 3 months of standard conventional therapies such as antibiotics and/or systemic retinoids
• Willing to use contraception unless not of childbearing potential
• Able to comply with protocol requirements

Exclusion Criteria:

• Received within 4 weeks prior immunosuppressive medication
• Received treatment within 3 months prior with systemic retinoids (acitretin or isotretinoin)
• Received high potency (class I or II) topical corticoid steroids, topical antibiotics, systemic antibiotics, or topical immunomodulators (tacrolimus or pimecrolimus) within 2 weeks prior to baseline visit
• Received intralesional injections of corticosteroids within 4 weeks prior
• Received surgical intervention for the treatment of HS
• Known history of HIV seropositivity
• History of untreated or active tuberculosis
• Active infection requiring systemic antibiotics within 4 weeks of baseline visit
• History of recurrent/chronic infections
• History of malignancy within 5 years of baseline visit (except for squamous cell carcinoma or basal cell carcinoma; may enroll if treated and assessed as cured).
• Pregnant or breastfeeding
• Immunocompromised due to a medical condition
• Has any significant laboratory abnormalities
• Has any medical condition that may interfere with evaluation of the safety and efficacy of efalizumab
• Received efalizumab or any other biologic within the last 6 months
• Taken or used any investigational drug or device within 30 days prior

Contacts and Locations

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Locations

United States, New York
New York University School of Medicine, Dept of Dermatology
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Genentech, Inc.

Investigators

Principal Investigator:	Bruce Strober, MD, PhD	New York University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00134134 History of Changes
Other Study ID Numbers:	H12452-01B
First Posted:	August 24, 2005
Last Update Posted:	September 11, 2006
Last Verified:	September 2006

Keywords provided by New York University School of Medicine:

hidradenitis suppurativa; efalizumab; biologic; Raptiva

Additional relevant MeSH terms:

Hidradenitis; Hidradenitis Suppurativa; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections	Skin Diseases, Infectious; Infection; Suppuration; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs