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Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00808223 |
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
Condition | Intervention | Phase |
---|---|---|
Psoriasis |
Biological: alefacept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004] |
Estimated Enrollment: | 50 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1. alefacept: Experimental |
Biological: alefacept
IM injection
|
A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Astellas Pharma US Medical Information | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
United States, California | |
San Diego, California, United States, 92123 | |
United States, Kentucky | |
Louisville, Kentucky, United States, 40217 | |
Bulgaria | |
Pleven, Bulgaria, 5800 | |
Plovdiv, Bulgaria, 4004 | |
Rousse, Bulgaria, 7000 | |
Sofia, Bulgaria | |
Latvia | |
Riga, Latvia, 1004 | |
Riga, Latvia, 1002 | |
Riga, Latvia, 1001 |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry ) |
Study ID Numbers: | 0485-CL-0004, EudraCT # 2008-005830-63 |
Study First Received: | December 11, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00808223 |
Health Authority: | United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Latvia: State Agency of Medicines |
alefacept adolescent psoriasis |
Alefacept Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |