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

Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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 Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: alefacept; Procedure: Narrow Band UVB Phototherapy

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1J 1X7
  • Alberta
    • Calgary, Alberta, Canada, T2S 3B3
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
    • Vancouver, British Columbia, Canada, V5Z 4E8
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
  • Ontario
    • London, Ontario, Canada, N5X 2P1
    • Markham, Ontario, Canada, L3P 1A8
    • Toronto, Ontario, Canada, M5S 1B6
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
    • Montreal, Quebec, Canada, H3H 1V4
    • Sainte-Foy, Quebec, Canada, G1V 4X7
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alefacept alone; 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks	Drug: alefacept; IM; Other Names: Amevive; ASP0485
Experimental: Alefacept + nbUVB; 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks	Procedure: Narrow Band UVB Phototherapy; UVB Phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study	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.	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.	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.	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.	Week 16
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study	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.	Week 36
Percentage of Subjects Who Achieve PASI 90 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 90 was defined as an improvement of at least 90% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Week 16
Time to Relapse	The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed. Relapse is defined by a loss of 50% of improvement in PASI.	Week 36
Time for 50% Decrease in PASI	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). Only subjects who experienced 50% decrease in PASI were included in the analysis.	Week 36
Time for a 75% Decrease in PASI	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). Only subjects who experienced 75% decrease in PASI were included in the analysis.	Week 36
Change in Dermatology Life Quality Index (DLQI)	The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst). 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.	Baseline and Week 36

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Canada, Inc.

Publications and helpful links

General Publications

• Lui H, Gulliver W, Tan J, Hong CH, Hull P, Shear NH, Paradiso-Hardy F, Bissonette R. A randomized controlled study of combination therapy with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012 Aug;11(8):929-37.

Helpful Links

• Link to Prescribing Information

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: phototherapy; plaque psoriasis; alefacept; Amevive; narrow band ultraviolet B
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: AME-001