CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Alefaceptdrug
Likely dose
Alefacept 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00655564
NCT00655564Phase 4Completed
CompareCT.gov

Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis

Wake Forest University·interventional·Posted Apr 10, 2008·Updated Sep 11, 2018

In Brief

A Phase 4 clinical trial evaluating Alefacept for Psoriasis. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.2 years ago

Interventions

Alefaceptdrug

Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).