Plaque Psoriasis Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
| Verified date | January 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1465 |
| Est. completion date | June 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject is >= 18 years of age - Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis - Subject is judged to be in generally good health as determined by the principal investigator Exclusion Criteria: - Subject has previous exposure to systemic anti-IL 12 therapy - Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy - Subject is taking or requires oral or injectible corticosteroids - Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis - Subject considered by the investigator, for any reason, to be an unsuitable candidate - Female subject who is pregnant or breast-feeding or considering becoming pregnant |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Site Reference ID/Investigator# 7314 | Barrie | |
| Canada | Site Reference ID/Investigator# 7452 | Calgary | |
| Canada | Site Reference ID/Investigator# 6702 | Edmonton | |
| Canada | Site Reference ID/Investigator# 6716 | Halifax | |
| Canada | Site Reference ID/Investigator# 7309 | Hamilton | |
| Canada | Site Reference ID/Investigator# 6588 | Laval | |
| Canada | Site Reference ID/Investigator# 6715 | London | |
| Canada | Site Reference ID/Investigator# 7315 | London | |
| Canada | Site Reference ID/Investigator# 7636 | Markham | |
| Canada | Site Reference ID/Investigator# 6699 | Montreal | |
| Canada | Site Reference ID/Investigator# 7316 | Montreal | |
| Canada | Site Reference ID/Investigator# 7088 | North Bay | |
| Canada | Site Reference ID/Investigator# 7310 | Ottawa | |
| Canada | Site Reference ID/Investigator# 7311 | Quebec City | |
| Canada | Site Reference ID/Investigator# 7313 | St. John's | |
| Canada | Site Reference ID/Investigator# 7317 | Surrey | |
| Canada | Site Reference ID/Investigator# 6713 | Vancouver | |
| Canada | Site Reference ID/Investigator# 7308 | Vancouver | |
| Canada | Site Reference ID/Investigator# 7067 | Waterloo | |
| Canada | Site Reference ID/Investigator# 7312 | Westmount | |
| Canada | Site Reference ID/Investigator# 6805 | Windsor | |
| Canada | Site Reference ID/Investigator# 7087 | Windsor | |
| Canada | Site Reference ID/Investigator# 7638 | Winnipeg | |
| United States | Site Reference ID/Investigator# 7030 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 6582 | Alpharetta | Georgia |
| United States | Site Reference ID/Investigator# 6597 | Andover | Massachusetts |
| United States | Site Reference ID/Investigator# 6825 | Arlington | Texas |
| United States | Site Reference ID/Investigator# 7017 | Arlington Heights | Illinois |
| United States | Site Reference ID/Investigator# 7450 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 6762 | Austin | Texas |
| United States | Site Reference ID/Investigator# 6591 | Bakersfield | California |
| United States | Site Reference ID/Investigator# 7299 | Berlin | New Jersey |
| United States | Site Reference ID/Investigator# 6579 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 6697 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 6703 | Boston | Massachusetts |
| United States | Site Reference ID/Investigator# 7878 | Buffalo | New York |
| United States | Site Reference ID/Investigator# 6598 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 8082 | Cleveland | Ohio |
| United States | Site Reference ID/Investigator# 7165 | Columbus | Ohio |
| United States | Site Reference ID/Investigator# 6822 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7671 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7659 | Dayton | Ohio |
| United States | Site Reference ID/Investigator# 7302 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 7644 | Detroit | Michigan |
| United States | Site Reference ID/Investigator# 6924 | East Windsor | New Jersey |
| United States | Site Reference ID/Investigator# 6826 | Fort Gratiot | Michigan |
| United States | Site Reference ID/Investigator# 6710 | Fresno | California |
| United States | Site Reference ID/Investigator# 6581 | Fridley | Minnesota |
| United States | Site Reference ID/Investigator# 6586 | Goodlettsville | Tennessee |
| United States | Site Reference ID/Investigator# 7989 | Grand Blanc | Michigan |
| United States | Site Reference ID/Investigator# 6589 | Greer | South Carolina |
| United States | Site Reference ID/Investigator# 7879 | Hershey | Pennsylvania |
| United States | Site Reference ID/Investigator# 6926 | Hickory | North Carolina |
| United States | Site Reference ID/Investigator# 6705 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7015 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 6706 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 7646 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 7885 | Irvine | California |
| United States | Site Reference ID/Investigator# 6707 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 6580 | Johnston | Rhode Island |
| United States | Site Reference ID/Investigator# 7668 | Knoxville | Tennessee |
| United States | Site Reference ID/Investigator# 6727 | Lake Oswego | Oregon |
| United States | Site Reference ID/Investigator# 6696 | Little Rock | Arkansas |
| United States | Site Reference ID/Investigator# 6921 | Longmont | Colorado |
| United States | Site Reference ID/Investigator# 6872 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 6873 | Louisville | Kentucky |
| United States | Site Reference ID/Investigator# 7877 | Maywood | Illinois |
| United States | Site Reference ID/Investigator# 6831 | Miami | Florida |
| United States | Site Reference ID/Investigator# 7012 | Miami | Florida |
| United States | Site Reference ID/Investigator# 7301 | Miami | Florida |
| United States | Site Reference ID/Investigator# 7080 | Milwaukee | Wisconsin |
| United States | Site Reference ID/Investigator# 6915 | Nashville | Tennessee |
| United States | Site Reference ID/Investigator# 6577 | New Brunswick | New Jersey |
| United States | Site Reference ID/Investigator# 6917 | New Haven | Connecticut |
| United States | Site Reference ID/Investigator# 6599 | New York | New York |
| United States | Site Reference ID/Investigator# 6895 | New York | New York |
| United States | Site Reference ID/Investigator# 7637 | New York | New York |
| United States | Site Reference ID/Investigator# 7876 | New York | New York |
| United States | Site Reference ID/Investigator# 6714 | Newnan | Georgia |
| United States | Site Reference ID/Investigator# 6807 | Norfolk | Virginia |
| United States | Site Reference ID/Investigator# 7669 | Oceanside | California |
| United States | Site Reference ID/Investigator# 7451 | Omaha | Nebraska |
| United States | Site Reference ID/Investigator# 7014 | Overland Park | Kansas |
| United States | Site Reference ID/Investigator# 7523 | Owensboro | Kentucky |
| United States | Site Reference ID/Investigator# 6712 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 6578 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 6894 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 7295 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 6576 | Providence | Rhode Island |
| United States | Site Reference ID/Investigator# 7504 | Rochester | New York |
| United States | Site Reference ID/Investigator# 8101 | Salt Lake City | Utah |
| United States | Site Reference ID/Investigator# 6708 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7081 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 6821 | San Diego | California |
| United States | Site Reference ID/Investigator# 6832 | San Diego | California |
| United States | Site Reference ID/Investigator# 7305 | San Diego | California |
| United States | Site Reference ID/Investigator# 7990 | San Francisco | California |
| United States | Site Reference ID/Investigator# 6711 | Santa Monica | California |
| United States | Site Reference ID/Investigator# 6728 | Scottsdale | Arizona |
| United States | Site Reference ID/Investigator# 6801 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 6704 | Skokie | Illinois |
| United States | Site Reference ID/Investigator# 6717 | Snellville | Georgia |
| United States | Site Reference ID/Investigator# 7016 | South Miami | Florida |
| United States | Site Reference ID/Investigator# 7519 | Spokane | Washington |
| United States | Site Reference ID/Investigator# 6709 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 7890 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 7018 | Stoney Brook | New York |
| United States | Site Reference ID/Investigator# 8139 | Torrance | California |
| United States | Site Reference ID/Investigator# 6584 | Tucson | Arizona |
| United States | Site Reference ID/Investigator# 6912 | Tyler | Texas |
| United States | Site Reference ID/Investigator# 7167 | Vallejo | California |
| United States | Site Reference ID/Investigator# 7306 | Webster | Texas |
| United States | Site Reference ID/Investigator# 7292 | West Dundee | Illinois |
| United States | Site Reference ID/Investigator# 6590 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 7293 | Wilmington | North Carolina |
| United States | Site Reference ID/Investigator# 8251 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PGA | Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 | No | |
| Primary | PASI | Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 | No | |
| Primary | PGA | Proportion of subjects maintaining a PGA 0/1 response at Week 52 | No | |
| Secondary | DLQI | Change from Baseline in DLQI total score vs. placebo at Week 12 | No | |
| Secondary | NAPSI | % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis | No | |
| Secondary | PASI | Subjects who achieve PASI 90 and 100 at Week 12 | No | |
| Secondary | Safety parameters | Throughout study | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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