Alefacept Mechanism of Action in Psoriasis

Phase 2

Completed

• Conditions: Psoriasis

• Registration Number: NCT00150982
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Study Timeline

• Study Start: 2003-09
• Study Completion: 2005-02
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-06
• Last Update Posted: 2008-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UMDNJ Clinical Research Center; 🇺🇸 New Brunswick, New Jersey, United States