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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 Study

Change 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

Page last updated: August 20, 2015

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