Psoriasis
Conditions
Keywords
psoriasis, alefacept
Brief summary
To determine the mechanism of action of alefacept in patients with psoriasis.
Detailed 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.
Interventions
DRUGMechanism of action of alefacept
Sponsors
Biogen
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts. | — |
Countries
United States
Outcome results
None listed