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

NCT ID: NCT00134134

Last Updated: 2006-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-08-31

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.

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa; efalizumab; biologic; Raptiva

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

efalizumab

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Principal Investigators

Bruce Strober, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine, Dept of Dermatology

New York, New York, United States

Countries

United States

Other Identifiers

H12452-01B

Identifier Type: -

Identifier Source: org_study_id