A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis

A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00674063

Enrollment

Registered

2008-05-07

Start date

2003-07-31

Completion date

2004-04-30

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

Chronic Plaque Psoriasis, Alefacept

Brief summary

Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis

Interventions

DRUGalefacept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Body weight between 100kg and 150kg * Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10% * Candidate for phototherapy or systemic therapy for Psoriasis * CD4 + T lymphocyte counts \> lower limit of normal

Exclusion criteria

* Clinically significant abnormal hematology values or blood chemistry values * ALT or AST value of ≥ 3x the upper limit of normal * Other types of Psoriasis * Serious infection within 3 months prior to 1st dose of study drug * Antibody positive for HIV * History of malignancy * History of severe allergic or anaphylactic reactions * History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease

Design outcomes

Primary

Measure	Time frame
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline	1 Week post treatment

Secondary

Measure	Time frame
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline	1 Week post treatment

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026