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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00134134
First received: August 23, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

No publications provided

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

Keywords provided by New York University School of Medicine:
hidradenitis suppurativa
efalizumab
biologic
Raptiva

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration

ClinicalTrials.gov processed this record on April 17, 2014