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CompletedNCT00134134Updated Sep 11, 2006

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

A Phase 1 interventional study of efalizumab in Hidradenitis Suppurativa, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-09-11.

Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • hidradenitis suppurativa
  • efalizumab
  • biologic
  • Raptiva
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 5 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants

Interventions

  • Drugefalizumab
06

What researchers measure

Primary outcomes

  1. Reduction in number of inflammatory lesions 12 weeks post-baseline

Secondary outcomes

  1. Time to the reduction of lesions during 12 weeks of treatment

  2. Percent of disease activity at various weeks after baseline

07

Study locations

1 site
  • New York University School of Medicine, Dept of Dermatology
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00134134
Lead sponsor
NYU Langone Health
Collaborators
Genentech, Inc.
First posted
Aug 24, 2005
Start date
Feb 2005
Completion
Aug 2006
Last update
Sep 11, 2006

Study contacts

Bruce Strober, MD, PhD
principal investigator · NYU Langone Health
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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