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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: alefacept
* Procedure: Narrow Band UVB Phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alefacept alone<br>15 mg alefacept intramuscularly (IM) once weekly for 12 weeks | Drug: alefacept<br>* IM<br>* Other names: ASP0485;|
| Experimental: Alefacept + nbUVB<br>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<br>* UVB Phototherapy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque psoriasis, alefacept, Amevive, narrow band ultraviolet B, phototherapy