Efalizumab for Moderate to Severe Atopic Dermatitis

December 31, 2019 updated by: Eric Simpson, Oregon Health and Science University

Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults

The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age >= 18 years
  • If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary.
  • Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria
  • Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score
  • Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
  • Patients must meet the following washout requirements:

Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study)

Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study

Exclusion Criteria:

  • Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components
  • Pregnant or lactating women
  • Patients receiving immunosuppressive agents
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial
  • Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome)
  • Systemic corticosteroid-dependent asthma
  • Active infection of any type at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raptiva Open Label
Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.
Drug: Raptiva
Open Label
Other Names:
  • Efalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis
Time Frame: EASI Score collected at 12 weeks following baseline
The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline
EASI Score collected at 12 weeks following baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in EASI score
Time Frame: Assessed 12 weeks after baseline
Total percent of patients reaching 50% improvement in EASI score
Assessed 12 weeks after baseline
Improvement in IGA score
Time Frame: Assessed 12 weeks after baseline
Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score
Assessed 12 weeks after baseline
Subject's assessment of overall response
Time Frame: End of study
Subject's assessment of overall response
End of study
Change in serum IgE level
Time Frame: Serum IgE collected at 12 weeks following baseline
Change in serum IgE Level
Serum IgE collected at 12 weeks following baseline
Pruritis (0-10 VAS Scale) change
Time Frame: VAS scale collected at 12 weeks following baseline
Pruritis (0-10 VAS Scale) change
VAS scale collected at 12 weeks following baseline
Time to first response
Time Frame: Assessed on Days 28,56, and 84
Time to first response as defined by a decrease of 25% in EASI score
Assessed on Days 28,56, and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Eric L Simpson, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 578

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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