Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

NCT00832585 | Completed Phase 4 Results

• 1 other identifier: AC 07-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic; Dermatitis; chronic; skin

Outcome Measures

Primary Outcomes (1)

• Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.

  The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.

  Week 1 to week 16

Secondary Outcomes (1)

• Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.

  Week 1 to week 16

Study Arms (1)

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 at a dose of 15mg IM every week for 12 weeks. 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

Interventions

Alefacept DRUG

Alefacept 15mg IM every week for 12 weeks

Also known as: Amevive

Alefacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Rush University Medical Center - Department of Dermatology

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Bronchiolitis Obliterans Syndrome

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Results Point of Contact

• Title: Dr. Michael D. Tharp
• Organization: Rush University Medical Center - Department of Dermatology

derm@rush.edu

312-563-4001

Study Officials

• Michael D. Tharp, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 10, 2011
• Results First Posted: January 28, 2011

Record last verified: 2011-03

Locations

US (1)