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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005830-63 | EudraCT Number |
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To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
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. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. alefacept | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alefacept | Biological | IM injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets | 4 Weeks | |
| Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vice President Medical Affairs | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric and Adolescent Dermatology | San Diego | California | 92123 | United States | ||
| Physicians Skin Care, PLLC |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077944 | Alefacept |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Louisville |
| Kentucky |
| 40217 |
| United States |
| First Municipal Hospital for Active Treatment - Sofia | Sofia | 1000 | Bulgaria |
| Skin and STD Clinical Centre | Riga | 1001 | Latvia |
| Department of Dermatology No.17, Children Clinical Hospital | Riga | 1004 | Latvia |
| D002241 |
| Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |