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To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.
The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MEDI-507 |
|
| 2 | Placebo Comparator |
| |
| 3 | Active Comparator | MEDI-507 |
|
| 4 | Active Comparator | MEDI-507 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-507 | Drug | Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) | Days 14, 28, 42, 56, 70, 91, 107, and 167 |
| Measure | Description | Time Frame |
|---|---|---|
| Observe adverse and serious adverse events | Day 107 and 167 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine A Dingivan, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services (US) Inc. | Phoenix | Arizona | 85040 | United States | ||
| Bressinck-Parker-Dinehart-Sangster Dermatology, PA |
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| Placebo | Other |
|
| MEDI-507 | Drug | Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks) |
|
| MEDI-507 | Drug | Administered 7 mg for 4 weeks by injection (Monoclonal Antibody) |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Associates in Research, Inc. | Fresno | California | 93710 | United States |
| nTouch Research Corporation | San Diego | California | 92103 | United States |
| Solano Clinical Research | Vallejo | California | 94589 | United States |
| Dermatology Specialists, Inc. | Vista | California | 92083 | United States |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80210 | United States |
| Cherry Creek Dermatology | Denver | Colorado | 80246 | United States |
| The Savin Center, PC | New Haven | Connecticut | 06511 | United States |
| North Florida Dermatology Associates, PA | Jacksonville | Florida | 32204 | United States |
| ICSL-Clinical Studies | Sarasota | Florida | 34232 | United States |
| Comprehensive Research Institute | Tampa | Florida | 33607 | United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30005 | United States |
| Northwestern University Medical School | Chicago | Illinois | 60611-2923 | United States |
| Research Solutions, LLC | Evansville | Indiana | 47714 | United States |
| The South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| FutureCare Studies | Springfield | Massachusetts | 01107 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center | New Brunswick | New Jersey | 08903-0019 | United States |
| Probe Inc. | Riverside Park | New Jersey | 08075 | United States |
| Associates in Dermatology Research | Rutherford | New Jersey | 07070 | United States |
| Sadick Research Group | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| University Dermatology Consultants, Inc. | Cincinnatti | Ohio | 45219 | United States |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | United States |
| Northeast Clinical Research Center | Allentown | Pennsylvania | 18104 | United States |
| Paddington Testing Company | Philadelphia | Pennsylvania | 19103 | United States |
| Radiant Research | Philadelphia | Pennsylvania | 19115 | United States |
| Clinicalm Partners-LLC | Johnston | Rhode Island | 02919 | United States |
| Harmony Clinical Research, Inc. | Johnson City | Tennessee | 37601 | United States |
| Dermatology Consultants, PC | Nashville | Tennessee | 37205 | United States |
| Veteran's Administration Medical Center | Nashville | Tennessee | 37212-2637 | United States |
| Breco Research, Ltd. | Houston | Texas | 77024 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| The Dermatology Centre | Calgary | Alberta | T2S 3B3 | Canada |
| NewLab Clinical Research | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 1V8 | Canada |
| Probity Medical Research | Waterloo | Ontario | N2J 1B7 | Canada |
| Probity Medical Research | Windsor | Ontario | N8X 3V6 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
| International Dermatology Research | Montreal | Quebec | H3H 1V4 | Canada |
| ID | Term |
|---|---|
| C544394 | siplizumab |
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