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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00134134
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : September 11, 2006
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
NYU Langone Health

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

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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, Older 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134134


Locations
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United States, New York
New York University School of Medicine, Dept of Dermatology
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Genentech, Inc.
Investigators
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Principal Investigator: Bruce Strober, MD, PhD NYU Langone Health
More Information
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ClinicalTrials.gov Identifier: NCT00134134    
Other Study ID Numbers: H12452-01B
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006
Keywords provided by NYU Langone Health:
hidradenitis suppurativa
efalizumab
biologic
Raptiva
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
 Skin Diseases, Infectious
Infection
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs