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

Sponsors and Collaborators:	New York University School of Medicine Genentech
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00134134

Purpose

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	Intervention	Phase
Hidradenitis Suppurativa	Drug: efalizumab	Phase I

MedlinePlus related topics: Hidradenitis Suppurativa

Drug Information available for: Efalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Reduction in number of inflammatory lesions 12 weeks post-baseline

Secondary Outcome Measures:

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

Estimated Enrollment:	5
Study Start Date:	February 2005
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134134

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

Investigators

Principal Investigator:

Bruce Strober, MD, PhD

New York University School of Medicine

More Information

Study ID Numbers:	H12452-01B
Study First Received:	August 23, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00134134
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:

hidradenitis suppurativa
efalizumab
biologic
Raptiva

Study placed in the following topic categories:

Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Skin Diseases, Bacterial

Suppuration
Hidradenitis
Hidradenitis suppurativa
Hidradenitis Suppurativa

Additional relevant MeSH terms:

Sweat Gland Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009