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The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Arm #1 is used for entire study. At week 12, arm is rerandomized. |
|
| 2 | Active Comparator | Arm #2 is used for entire study. At week 12, arm is rerandomized. |
|
| 3 | Active Comparator | Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PGA | Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 | |
| PASI | Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 | |
| PGA | Proportion of subjects maintaining a PGA 0/1 response at Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| DLQI | Change from Baseline in DLQI total score vs. placebo at Week 12 | |
| NAPSI | % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis | |
| PASI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Kaul, MD | AbbVie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 6579 | Birmingham | Alabama | 35205 | United States | ||
| Site Reference ID/Investigator# 6697 |
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| ABT-874 | Biological | 200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks. |
|
| ABT-874 | Biological | 100mg every 12 weeks. |
|
| Subjects who achieve PASI 90 and 100 at Week 12 |
| Safety parameters | Throughout study |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Site Reference ID/Investigator# 7015 | Huntsville | Alabama | 35801 | United States |
| Site Reference ID/Investigator# 6728 | Scottsdale | Arizona | 85251 | United States |
| Site Reference ID/Investigator# 6584 | Tucson | Arizona | 85710 | United States |
| Site Reference ID/Investigator# 6696 | Little Rock | Arkansas | 72205 | United States |
| Site Reference ID/Investigator# 6591 | Bakersfield | California | 93309 | United States |
| Site Reference ID/Investigator# 6710 | Fresno | California | 93720 | United States |
| Site Reference ID/Investigator# 7885 | Irvine | California | 92697 | United States |
| Site Reference ID/Investigator# 6872 | Los Angeles | California | 90045 | United States |
| Site Reference ID/Investigator# 7669 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 6821 | San Diego | California | 92103 | United States |
| Site Reference ID/Investigator# 6832 | San Diego | California | 92117 | United States |
| Site Reference ID/Investigator# 7305 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 7990 | San Francisco | California | 94118 | United States |
| Site Reference ID/Investigator# 6711 | Santa Monica | California | 90404 | United States |
| Site Reference ID/Investigator# 8139 | Torrance | California | 90503 | United States |
| Site Reference ID/Investigator# 7167 | Vallejo | California | 94589 | United States |
| Site Reference ID/Investigator# 7302 | Denver | Colorado | 80209 | United States |
| Site Reference ID/Investigator# 6921 | Longmont | Colorado | 80501 | United States |
| Site Reference ID/Investigator# 6917 | New Haven | Connecticut | 06511 | United States |
| Site Reference ID/Investigator# 6707 | Jacksonville | Florida | 32204 | United States |
| Site Reference ID/Investigator# 7301 | Miami | Florida | 33136 | United States |
| Site Reference ID/Investigator# 7012 | Miami | Florida | 33144 | United States |
| Site Reference ID/Investigator# 6831 | Miami | Florida | 33173 | United States |
| Site Reference ID/Investigator# 7016 | South Miami | Florida | 33143 | United States |
| Site Reference ID/Investigator# 6590 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 6582 | Alpharetta | Georgia | 30022 | United States |
| Site Reference ID/Investigator# 7450 | Atlanta | Georgia | 30327 | United States |
| Site Reference ID/Investigator# 6714 | Newnan | Georgia | 30263 | United States |
| Site Reference ID/Investigator# 6717 | Snellville | Georgia | 30078 | United States |
| Site Reference ID/Investigator# 7017 | Arlington Heights | Illinois | 60005 | United States |
| Site Reference ID/Investigator# 7877 | Maywood | Illinois | 60153 | United States |
| Site Reference ID/Investigator# 6704 | Skokie | Illinois | 60077 | United States |
| Site Reference ID/Investigator# 7292 | West Dundee | Illinois | 60118 | United States |
| Site Reference ID/Investigator# 6706 | Indianapolis | Indiana | 46256 | United States |
| Site Reference ID/Investigator# 7646 | Indianapolis | Indiana | 46260 | United States |
| Site Reference ID/Investigator# 7014 | Overland Park | Kansas | 66202 | United States |
| Site Reference ID/Investigator# 6873 | Louisville | Kentucky | 40202 | United States |
| Site Reference ID/Investigator# 7523 | Owensboro | Kentucky | 42303 | United States |
| Site Reference ID/Investigator# 6597 | Andover | Massachusetts | 01810 | United States |
| Site Reference ID/Investigator# 6703 | Boston | Massachusetts | 02111 | United States |
| Site Reference ID/Investigator# 7644 | Detroit | Michigan | 48202 | United States |
| Site Reference ID/Investigator# 6826 | Fort Gratiot | Michigan | 48059 | United States |
| Site Reference ID/Investigator# 7989 | Grand Blanc | Michigan | 48439 | United States |
| Site Reference ID/Investigator# 6581 | Fridley | Minnesota | 55432 | United States |
| Site Reference ID/Investigator# 7890 | St Louis | Missouri | 63110 | United States |
| Site Reference ID/Investigator# 6709 | St Louis | Missouri | 63117 | United States |
| Site Reference ID/Investigator# 7451 | Omaha | Nebraska | 68144 | United States |
| Site Reference ID/Investigator# 7299 | Berlin | New Jersey | 08009 | United States |
| Site Reference ID/Investigator# 6924 | East Windsor | New Jersey | 08520 | United States |
| Site Reference ID/Investigator# 6577 | New Brunswick | New Jersey | 08903 | United States |
| Site Reference ID/Investigator# 7030 | Albuquerque | New Mexico | 87106 | United States |
| Site Reference ID/Investigator# 7878 | Buffalo | New York | 14221 | United States |
| Site Reference ID/Investigator# 7876 | New York | New York | 10016 | United States |
| Site Reference ID/Investigator# 6599 | New York | New York | 10025 | United States |
| Site Reference ID/Investigator# 6895 | New York | New York | 10029-6501 | United States |
| Site Reference ID/Investigator# 7637 | New York | New York | 10032 | United States |
| Site Reference ID/Investigator# 7504 | Rochester | New York | 14623 | United States |
| Site Reference ID/Investigator# 7018 | Stoney Brook | New York | 11790 | United States |
| Site Reference ID/Investigator# 6926 | Hickory | North Carolina | 28601 | United States |
| Site Reference ID/Investigator# 7293 | Wilmington | North Carolina | 28401 | United States |
| Site Reference ID/Investigator# 8251 | Winston-Salem | North Carolina | 27157 | United States |
| Site Reference ID/Investigator# 6598 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 8082 | Cleveland | Ohio | 44106 | United States |
| Site Reference ID/Investigator# 7165 | Columbus | Ohio | 43212 | United States |
| Site Reference ID/Investigator# 7659 | Dayton | Ohio | 45408 | United States |
| Site Reference ID/Investigator# 6727 | Lake Oswego | Oregon | 97035 | United States |
| Site Reference ID/Investigator# 6894 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 6578 | Portland | Oregon | 97223 | United States |
| Site Reference ID/Investigator# 7295 | Portland | Oregon | 97239 | United States |
| Site Reference ID/Investigator# 7879 | Hershey | Pennsylvania | 17033 | United States |
| Site Reference ID/Investigator# 6712 | Philadelphia | Pennsylvania | 19103 | United States |
| Site Reference ID/Investigator# 6580 | Johnston | Rhode Island | 02919 | United States |
| Site Reference ID/Investigator# 6576 | Providence | Rhode Island | 02903 | United States |
| Site Reference ID/Investigator# 6589 | Greer | South Carolina | 29651 | United States |
| Site Reference ID/Investigator# 6586 | Goodlettsville | Tennessee | 37072 | United States |
| Site Reference ID/Investigator# 7668 | Knoxville | Tennessee | 37934 | United States |
| Site Reference ID/Investigator# 6915 | Nashville | Tennessee | 37215 | United States |
| Site Reference ID/Investigator# 6825 | Arlington | Texas | 76011 | United States |
| Site Reference ID/Investigator# 6762 | Austin | Texas | 78759 | United States |
| Site Reference ID/Investigator# 6822 | Dallas | Texas | 75230 | United States |
| Site Reference ID/Investigator# 7671 | Dallas | Texas | 75246-1613 | United States |
| Site Reference ID/Investigator# 6705 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 6708 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 7081 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 6912 | Tyler | Texas | 75703 | United States |
| Site Reference ID/Investigator# 7306 | Webster | Texas | 77598 | United States |
| Site Reference ID/Investigator# 8101 | Salt Lake City | Utah | 84132 | United States |
| Site Reference ID/Investigator# 6807 | Norfolk | Virginia | 23507 | United States |
| Site Reference ID/Investigator# 6801 | Seattle | Washington | 98101 | United States |
| Site Reference ID/Investigator# 7519 | Spokane | Washington | 99204 | United States |
| Site Reference ID/Investigator# 7080 | Milwaukee | Wisconsin | 53209 | United States |
| Site Reference ID/Investigator# 7314 | Barrie | L4M 6L2 | Canada |
| Site Reference ID/Investigator# 7452 | Calgary | T3A 2N1 | Canada |
| Site Reference ID/Investigator# 6702 | Edmonton | T5K 1X3 | Canada |
| Site Reference ID/Investigator# 6716 | Halifax | B3H 0A2 | Canada |
| Site Reference ID/Investigator# 7309 | Hamilton | L8N 1V6 | Canada |
| Site Reference ID/Investigator# 6588 | Laval | H7S 2C6 | Canada |
| Site Reference ID/Investigator# 6715 | London | N5X 2P1 | Canada |
| Site Reference ID/Investigator# 7315 | London | N6A 3H7 | Canada |
| Site Reference ID/Investigator# 7636 | Markham | L3P 1A8 | Canada |
| Site Reference ID/Investigator# 6699 | Montreal | H2K 4L5 | Canada |
| Site Reference ID/Investigator# 7316 | Montreal | H3H 1V4 | Canada |
| Site Reference ID/Investigator# 7088 | North Bay | P1B 3Z7 | Canada |
| Site Reference ID/Investigator# 7310 | Ottawa | K2G 6E2 | Canada |
| Site Reference ID/Investigator# 7311 | Québec | G1V 4X7 | Canada |
| Site Reference ID/Investigator# 7313 | St. John's | A1A 5E8 | Canada |
| Site Reference ID/Investigator# 7317 | Surrey | V3R 6A7 | Canada |
| Site Reference ID/Investigator# 7308 | Vancouver | V5Z 3Y1 | Canada |
| Site Reference ID/Investigator# 6713 | Vancouver | V5Z 4E8 | Canada |
| Site Reference ID/Investigator# 7067 | Waterloo | N2J 1C4 | Canada |
| Site Reference ID/Investigator# 7312 | Westmount | H3Z 2S6 | Canada |
| Site Reference ID/Investigator# 7087 | Windsor | N8W 1E6 | Canada |
| Site Reference ID/Investigator# 6805 | Windsor | N8W 5L7 | Canada |
| Site Reference ID/Investigator# 7638 | Winnipeg | R3C 1R4 | Canada |
| ID | Term |
|---|---|
| C544528 | briakinumab |
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