Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
This study has been completed.
Sponsor:
New York University School of Medicine
Collaborator:
Genentech, Inc.
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
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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:
Genetics Home Reference related topics:
hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
U.S. FDA Resources
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 |
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 (Adult) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134134
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, Inc.
Investigators
| Principal Investigator: | Bruce Strober, MD, PhD | New York University School of Medicine |
More Information
| 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 Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016