Clinical trial NCT00658606: Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
alefacept
Amevive
narrow band ultraviolet B
phototherapy
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2008-04-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
timeFrame: Week 36
measure: Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
timeFrame: Baseline and Week 16
measure: Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
timeFrame: Baseline and Week 36
measure: Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
timeFrame: Week 16
measure: Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
timeFrame: Week 36
measure: Percentage of Subjects Who Achieve PASI 90 at Week 16
timeFrame: Week 16
measure: Time to Relapse
timeFrame: Week 36
measure: Time for 50% Decrease in PASI
timeFrame: Week 36
measure: Time for a 75% Decrease in PASI
timeFrame: Week 36
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Week 36
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.