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

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
efalizumab
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring hidradenitis suppurativa, efalizumab, biologic, Raptiva

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine, Dept of Dermatology

Outcomes

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

Full Information

First Posted
August 23, 2005
Last Updated
September 7, 2006
Sponsor
NYU Langone Health
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00134134
Brief Title
Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Official Title
An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NYU Langone Health
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
hidradenitis suppurativa, efalizumab, biologic, Raptiva

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
efalizumab
Primary Outcome Measure Information:
Title
Reduction in number of inflammatory lesions 12 weeks post-baseline
Secondary Outcome Measure Information:
Title
Time to the reduction of lesions during 12 weeks of treatment
Title
Percent of disease activity at various weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Strober, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine, Dept of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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