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The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MEDI-522 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-522 | Drug | 4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving at least a 50% or 75% improvement of PASI | PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | through Study Day 167 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara White, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA | Little Rock | Arkansas | 72205 | United States | ||
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| Placebo | Other | 4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0) |
|
| Associates In Research, Inc. |
| Fresno |
| California |
| 93710 |
| United States |
| Solano Dermatology Associates | Vallejo | California | 94589 | United States |
| Dermatology Specialists | Vista | California | 92083 | United States |
| The Savin Center, P.C. | New Haven | Connecticut | 06511-4808 | United States |
| North Florida Dermatology Associates, P.A. | Jacksonville | Florida | 32204 | United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30005 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| FutureCare Studies, INC | Springfield | Massachusetts | 01107 | United States |
| Midwest Cutaneous Research, Corp. | Clinton Township | Michigan | 48038 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| Karen Harkaway, M.D., LLC | Riverside Park | New Jersey | 08075 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| NorthEast Clinical Research Centers, Inc | Allentown | Pennsylvania | 18103 | United States |
| Clincial Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Harmony Clinical Research | Johnson City | Tennessee | 37601 | United States |
| Tenn. Clinical Research Center, INC | Nashville | Tennessee | 37215 | United States |
| Derm. Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| North Bay Dermatology Center | North Bay | Ontario | P1B 2T6 | Canada |
| Probity Medical Research, Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| 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 |
|---|---|
| C112567 | etaracizumab |
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