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

Hidradenitis Suppurativa Clinical Trial

Official title:

An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134134
• Other study ID #: H12452-01B
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2005
• Last updated: September 7, 2006
• Start date: February 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2006
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• efalizumab

Locations

Country	Name	City	State
United States	New York University School of Medicine, Dept of Dermatology	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of inflammatory lesions 12 weeks post-baseline
Secondary	Time to the reduction of lesions during 12 weeks of treatment
Secondary	Percent of disease activity at various weeks after baseline