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

NCT00134134 | Completed Phase 1

• 1 other identifier: H12452-01B
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa; efalizumab; biologic; Raptiva

Outcome Measures

Primary Outcomes (1)

• Reduction in number of inflammatory lesions 12 weeks post-baseline

Secondary Outcomes (2)

• Time to the reduction of lesions during 12 weeks of treatment

• Percent of disease activity at various weeks after baseline

Interventions

efalizumab DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Genentech, Inc.: collaborator

Study Sites (1)

New York University School of Medicine, Dept of Dermatology

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Bruce Strober, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 24, 2005
• Study Start: February 1, 2005
• Study Completion: August 1, 2006
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

US (1)