Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plaque Psoriasis
Intervention: alefacept (Drug); Narrow Band UVB Phototherapy (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
Secondary outcome: Percentage of Subjects Reaching PASI 75 Over the Entire Course of the StudyChange in Body Surface Area (BSA) Covered With Psoriasis at Week 16 Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16 Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study Percentage of Subjects Who Achieve PASI 90 at Week 16 Time to Relapse Time for 50% Decrease in PASI Time for a 75% Decrease in PASI Change in Dermatology Life Quality Index (DLQI)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Quebec G1J 1X7, Canada
Calgary, Alberta T2S 3B3, Canada
Surrey, British Columbia V3R 6A7, Canada
Vancouver, British Columbia V5Z 4E8, Canada
St. John's, Newfoundland and Labrador A1C 2H5, Canada
London, Ontario N5X 2P1, Canada
Markham, Ontario L3P 1A8, Canada
Toronto, Ontario M5S 1B6, Canada
Montreal, Quebec H2K 4L5, Canada
Montreal, Quebec H3H 1V4, Canada
Sainte-Foy, Quebec G1V 4X7, Canada
Saskatoon, Saskatchewan S7N 0W8, Canada
Additional Information
Link to Prescribing Information
Related 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.
Starting date: October 2007
Last updated: January 3, 2013
|