Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
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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
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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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