Alefacept Mechanism of Action in Psoriasis

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Mechanism of action of alefacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00150982

4588

Details and patient eligibility

About

To determine the mechanism of action of alefacept in patients with psoriasis.

Full description

The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).

Exclusion Criteria

• CD4 < 400/ml
• WBC less than lower level of normal for the reporting laboratory
• < 5% Body Surface Area involved with psoriasis
• Serious infection e.g., latent or active tuberculosis
• History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
• Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
• Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
• Inability to understand consent form or comply with study requirements
• Pregnancy or lactation
• Concurrent medical illness that would make participation in this clinical trial ill-advised
• Any contraindications to using alefacept

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)