Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Completed · Phase 1
Conditions studied: Hidradenitis Suppurativa
In brief
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.
Key facts
- Study ID
- NCT00134134
- Run by
- NYU Langone Health
- People needed
- 5
- Starts
- 2005-02-01
- Expected to finish
- 2006-08-01
- Last updated by the study team
- 2006-09-11
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York University School of Medicine, Dept of Dermatology — New York, New York, United States
Full record on ClinicalTrials.gov
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