Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Astellas Pharma Inc98 enrolled

Overview

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque Psoriasis

Interventions

alefaceptDRUG

Narrow Band UVB PhototherapyPROCEDURE

UVB Phototherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has given written informed consent * Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving \>=10% with a Psoriasis Area and Severity Index (PASI) score \>=10 at Baseline * Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal * Male and female subjects must use an adequate means of contraception from screening to end of study. Exclusion Criteria: * Subject who received alefacept in the past * Subject who has shown no improvement following an adequate course of nbUVB in the past * Subject who has been treated in the past with either therapy or cyclosporine * Subject with any active cancer, including skin cancer at Baseline * Subject with erythrodermic, pustular or predominantly guttate psoriasis * Subject who has used treatment for psoriasis prior to Baseline as follows: * Topical treatment within 14 days * Oral treatment within 28 days * Broad band UVB (bbUVB) or nbUVB treatment within 56 days * Biological treatment within 84 days * Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug * Subject with a history of drug or alcohol abuse within the past 2 years * Subject that is known to be infected with the AIDS virus * Subject with any other skin disease or other disease that might interfere with psoriasis status assessments * Female subject who is nursing, pregnant or planning to become pregnant while in this study * Subject who is currently enrolled in any other investigational drug or device study

Locations (12)

Unnamed facility

Calgary, Alberta, Canada

Unnamed facility

Surrey, British Columbia, Canada

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

St. John's, Newfoundland and Labrador, Canada

Outcomes

Primary Outcomes

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16

The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Time frame: Week 16

Secondary Outcomes

Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study

Time frame: Week 36

Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16

A negative change from Baseline represents improvement. Change is calculated as Week 16- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Time frame: Baseline and Week 16

Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study

A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Time frame: Baseline and Week 36

Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16

The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Data from ClinicalTrials.gov

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