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Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis
This study is currently recruiting participants.
Verified by Rush University Medical Center, June 2009
First Received: January 28, 2009   Last Updated: June 10, 2009   History of Changes
Sponsors and Collaborators: Rush University Medical Center
Astellas Pharma US, Inc.
Information provided by: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00832585
  Purpose

This study will assess the safety, tolerability, and efficacy of Alefacept in patient with moderate to severe atopic dermatitis who could not be adequately controlled with topical therapies.


Condition Intervention Phase
Atopic Dermatitis
Drug: Alefacept
Phase IV

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase IV, Open Label Study to Evaluate the Safety and Efficacy of Intramuscular (IM) Alefacept (Amevive) 15mg/wk in Subjects 18 Years and Older With Moderate to Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • To evaluate the response of atopic patients to a 12-week course of lM alefacept unresponsive to topical therapies utilizing a PGA scoring system. The primary efficacy outcome is the number of subjects with a PGA rating of 0-2. [ Time Frame: Weeks 6 and 12 during treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the time to relapse in subjects achieving the primary efficacy outcome measure of a PGA score 0-2. [ Time Frame: Weeks 6 and 12 of the post study phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alefacept: Experimental
Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes.
Drug: Alefacept
Alefacept 15mg IM every week for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form(s)
  • Age of l8 years or older
  • A diagnosis of atopic dermatitis as determined by the diagnostic criteria for atopic dermatitis
  • Disease severity of 3 or 4 (moderate or severe) as assessed by PGA rating (0-4 scale)
  • Be a candidate for systemic therapy who cannot be adequately controlled (ie have a PGA assessment of 3 014) with topical therapies (Le., medium-to high-potency topical corticosteroids, tacrolimus, or pimecrolimus).
  • For female subjects of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 3 months after the last dose of Alefacept
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other ultraviolet (UV) light sources during the study

EXCLUSION CRITERIA

  • History of hypersensitivity to alefacept or any of its components
  • History of illegal drug or alcohol abuse
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of eczema herpeticum within the 30 days prior to screening
  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • History of hepatitis B or C virus
  • History of active tuberculosis (TB) or currently undergoing treatment for TB.
  • Presence of history of malignancy within the past 5 years, including lymphoproliferative disorders.

Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled in the study

  • Pregnant or lactating women
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Hospital admission for cardiovascular or pulmonary disease within the year prior to screening, including hospitalization for asthma exacerbations
  • Subjects admitted to the hospital for chest pain that was subsequently determined to be non-cardiac in origin may be enrolled
  • History of clinically significant anemia
  • WBC count <4000/pL or> 14,000/pL
  • Use of experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the first dose of alefacept
  • Use of a live virus or live bacteria vaccine in the 14 days prior to be the first dose of alefacept
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol
  • Any subject whose baseline atopic dermatitis PGA rating has changed to 0, 1, or 2 (clear, almost clear, or mild) from a screening rating of 3,4, or 5 (moderate, severe, or very severe)

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832585

Contacts
Contact: Claudia R. Malik, BSN 312-563-4001 claudia.riechelamnn-malik@rush.edu
Contact: Danica Uzelac, BSN 312-563-4001 danica.uzelac@rush.edu

Locations
United States, Illinois
Rush University Medical Center - Department of Dermatology Recruiting
Chicago, Illinois, United States, 60612
Contact: Claudia R Malik, BSN     312-563-4001     claudia.riechelmann-malik@rush.edu    
Contact: Danica Uzelac, BSN     312-563-4001     danica.uzelac@rush.edu    
Principal Investigator: Michael D Tharp, MD            
Sponsors and Collaborators
Rush University Medical Center
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Michael D. Tharp, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Rush University Medical Center ( Michael D. Tharp )
Study ID Numbers: AC 07-001
Study First Received: January 28, 2009
Last Updated: June 10, 2009
ClinicalTrials.gov Identifier: NCT00832585     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Atopic
Dermatitis
chronic
skin

Study placed in the following topic categories:
Alefacept
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Alefacept
Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Pharmacologic Actions
Hypersensitivity
Genetic Diseases, Inborn
Therapeutic Uses
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatologic Agents
Dermatitis

ClinicalTrials.gov processed this record on August 28, 2009