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Efalizumab for Eczema

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Efalizumab treatment
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring eczema, atopic dermatitis, efalizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement Investigator Global Assessment (IGA) score of "moderate" or worse In general good health with well-controlled medical problems Ability to provide written informed consent and comply with study assessments for the full duration of the study. If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. Normal platelet count Exclusion Criteria: Patients with known hypersensitivity to efalizumab or any of its components Pregnancy or lactation Patients receiving immunosuppressive agents Prior enrollment in the study Participation in another simultaneous medical investigation or trial IGA score of "mild," "almost clear" or "clear" Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy. Ongoing, active, serious infection History of malignancy (except excised basal or squamous cell carcinoma of the skin)

Sites / Locations

  • UMDNJ Psoriasis Center of Excellence

Outcomes

Primary Outcome Measures

Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)

Secondary Outcome Measures

Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA
Percent improvement from baseline on the EASI (eczema area and severity index)
Photography (quarter-body views, front and back)
Pruritus improvement from baseline (rated on a scale of 1 to 10)

Full Information

First Posted
September 1, 2005
Last Updated
August 6, 2008
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00146003
Brief Title
Efalizumab for Eczema
Official Title
Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).
Detailed Description
The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
eczema, atopic dermatitis, efalizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efalizumab treatment
Primary Outcome Measure Information:
Title
Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)
Secondary Outcome Measure Information:
Title
Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA
Title
Percent improvement from baseline on the EASI (eczema area and severity index)
Title
Photography (quarter-body views, front and back)
Title
Pruritus improvement from baseline (rated on a scale of 1 to 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement Investigator Global Assessment (IGA) score of "moderate" or worse In general good health with well-controlled medical problems Ability to provide written informed consent and comply with study assessments for the full duration of the study. If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. Normal platelet count Exclusion Criteria: Patients with known hypersensitivity to efalizumab or any of its components Pregnancy or lactation Patients receiving immunosuppressive agents Prior enrollment in the study Participation in another simultaneous medical investigation or trial IGA score of "mild," "almost clear" or "clear" Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy. Ongoing, active, serious infection History of malignancy (except excised basal or squamous cell carcinoma of the skin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Magliocco, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ Psoriasis Center of Excellence
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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Efalizumab for Eczema

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