Alefacept Mechanism of Action in Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150982
• Other study ID #: 4588
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: August 6, 2008
• Start date: September 2003
• Est. completion date: February 2005

Study information

• Verified date: August 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Mechanism of action of alefacept

Locations

Country	Name	City	State
United States	UMDNJ Clinical Research Center	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary	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.