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

This study is ongoing, but not recruiting participants.

First Received: April 10, 2008 Last Updated: September 22, 2009 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma Canada, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00658606

Purpose

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

Condition	Intervention	Phase
Plaque Psoriasis	Drug: alefacept Procedure: Narrow Band UVB Phototherapy	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Proportion of subjects treated with alefacept and nbUVB who achieve Psoriasis Area and Severity Index (PASI) 75 as compared to subjects treated with alefacept alone [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Body Surface Area (BSA) covered with psoriasis for subjects treated with alefacept in combination with nbUVB as compared to subjects treated with alefacept alone [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

Enrollment:	98
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Alefacept alone: Active Comparator	Drug: alefacept IM
2. Alefacept + phototherapy: Experimental	Procedure: Narrow Band UVB Phototherapy UVB Phototherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has given written informed consent
Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a 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
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658606

Locations

Canada

Quebec, Canada, G1J 1X7
Canada, Alberta

Calgary, Alberta, Canada, T2S 3B3
Canada, British Columbia

Surrey, British Columbia, Canada, V3R 6A7

Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Newfoundland and Labrador

St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Ontario

Toronto, Ontario, Canada, M5S 1B6

London, Ontario, Canada, N5X 2P1

Markham, Ontario, Canada, L3P 1A8
Canada, Quebec

Montreal, Quebec, Canada, H3H 1V4

Sainte-Foy, Quebec, Canada, G1V 4X7

Montreal, Quebec, Canada, H2K 4L5
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Canada, Inc.

Investigators

Study Director:

Use Central Contact

Astellas Pharma Canada, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	AME-001
Study First Received:	April 10, 2008
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00658606 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

plaque psoriasis
alefacept
Amevive
narrow band ultraviolet B
phototherapy

Additional relevant MeSH terms:

Alefacept
Skin Diseases
Psoriasis
Therapeutic Uses

Dermatologic Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009