Clinical trial NCT00150982: Alefacept Mechanism of Action in Psoriasis
Official title: In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
alefacept
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-09-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ Clinical Research Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Alice Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: