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Efalizumab for Moderate to Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00226057
First received: September 22, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: Raptiva
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline as measured at 12 weeks.

Secondary Outcome Measures:
  • The following secondary efficacy outcome measures will be evaluated:
  • Total percent of patients reaching 50% improvement in EASI score
  • - Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score.
  • - Subject's assessment of overall response
  • - Change in serum IgE Level from baseline at 12 weeks
  • - Pruritis (0-10 VAS Scale) change from baseline at 12 weeks.
  • - Time to first response as defined by a decrease of 25% in EASI score on Days 28,56, and 84.

Estimated Enrollment: 10
Study Start Date: June 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226057

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Eric L Simpson, MD Oregon Health and Science University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00226057     History of Changes
Other Study ID Numbers: 578
Study First Received: September 22, 2005
Last Updated: September 22, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Atopic dermatitis
Raptiva

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 20, 2014