Status:
COMPLETED
Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Hidradenitis Suppurativa
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
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 tre...
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 thi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00134134
Start Date
February 1 2005
End Date
August 1 2006
Last Update
September 11 2006
Active Locations (1)
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1
New York University School of Medicine, Dept of Dermatology
New York, New York, United States, 10016