Efalizumab for Eczema

Dermatitis, Atopic Clinical Trial

Official title:

Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146003
• Other study ID #: 5163
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: August 6, 2008
• Start date: March 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Efalizumab treatment

Locations

Country	Name	City	State
United States	UMDNJ Psoriasis Center of Excellence	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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