A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Biological: ABT-874Drug: Placebo
- Registration Number
- NCT00570986
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1465
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ABT-874 Arm #2 is used for entire study. At week 12, arm is rerandomized. 3 ABT-874 Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized. 1 Placebo Arm #1 is used for entire study. At week 12, arm is rerandomized.
- Primary Outcome Measures
Name Time Method PGA Proportion of subjects maintaining a PGA 0/1 response at Week 52 PASI Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
- Secondary Outcome Measures
Name Time Method PASI Subjects who achieve PASI 90 and 100 at Week 12 NAPSI % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis DLQI Change from Baseline in DLQI total score vs. placebo at Week 12 Safety parameters Throughout study
Related Research Topics
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Trial Locations
- Locations (116)
Site Reference ID/Investigator# 7165
🇺🇸Columbus, Ohio, United States
Site Reference ID/Investigator# 6822
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 6712
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 7067
🇨🇦Waterloo, Canada
Site Reference ID/Investigator# 8139
🇺🇸Torrance, California, United States
Site Reference ID/Investigator# 7167
🇺🇸Vallejo, California, United States
Site Reference ID/Investigator# 7016
🇺🇸South Miami, Florida, United States
Site Reference ID/Investigator# 6584
🇺🇸Tucson, Arizona, United States
Site Reference ID/Investigator# 7669
🇺🇸Oceanside, California, United States
Site Reference ID/Investigator# 6702
🇨🇦Edmonton, Canada
Site Reference ID/Investigator# 6581
🇺🇸Fridley, Minnesota, United States
Site Reference ID/Investigator# 6826
🇺🇸Fort Gratiot, Michigan, United States
Site Reference ID/Investigator# 6709
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 7989
🇺🇸Grand Blanc, Michigan, United States
Site Reference ID/Investigator# 7309
🇨🇦Hamilton, Canada
Site Reference ID/Investigator# 6825
🇺🇸Arlington, Texas, United States
Site Reference ID/Investigator# 6588
🇨🇦Laval, Canada
Site Reference ID/Investigator# 6703
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 7878
🇺🇸Buffalo, New York, United States
Site Reference ID/Investigator# 7876
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 6710
🇺🇸Fresno, California, United States
Site Reference ID/Investigator# 6591
🇺🇸Bakersfield, California, United States
Site Reference ID/Investigator# 7885
🇺🇸Irvine, California, United States
Site Reference ID/Investigator# 6872
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 6711
🇺🇸Santa Monica, California, United States
Site Reference ID/Investigator# 6921
🇺🇸Longmont, Colorado, United States
Site Reference ID/Investigator# 7450
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 6717
🇺🇸Snellville, Georgia, United States
Site Reference ID/Investigator# 7877
🇺🇸Maywood, Illinois, United States
Site Reference ID/Investigator# 7017
🇺🇸Arlington Heights, Illinois, United States
Site Reference ID/Investigator# 6704
🇺🇸Skokie, Illinois, United States
Site Reference ID/Investigator# 7292
🇺🇸West Dundee, Illinois, United States
Site Reference ID/Investigator# 7646
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 7523
🇺🇸Owensboro, Kentucky, United States
Site Reference ID/Investigator# 6597
🇺🇸Andover, Massachusetts, United States
Site Reference ID/Investigator# 7890
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 7299
🇺🇸Berlin, New Jersey, United States
Site Reference ID/Investigator# 6924
🇺🇸East Windsor, New Jersey, United States
Site Reference ID/Investigator# 6577
🇺🇸New Brunswick, New Jersey, 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# 7301
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 7012
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 6831
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 6706
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 6705
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 7030
🇺🇸Albuquerque, New Mexico, United States
Site Reference ID/Investigator# 6895
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 6599
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 7637
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 7293
🇺🇸Wilmington, North Carolina, United States
Site Reference ID/Investigator# 7504
🇺🇸Rochester, New York, United States
Site Reference ID/Investigator# 7018
🇺🇸Stoney Brook, New York, United States
Site Reference ID/Investigator# 6926
🇺🇸Hickory, North Carolina, United States
Site Reference ID/Investigator# 6598
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 8082
🇺🇸Cleveland, Ohio, United States
Site Reference ID/Investigator# 7659
🇺🇸Dayton, Ohio, United States
Site Reference ID/Investigator# 6727
🇺🇸Lake Oswego, Oregon, United States
Site Reference ID/Investigator# 7879
🇺🇸Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 6580
🇺🇸Johnston, Rhode Island, United States
Site Reference ID/Investigator# 6576
🇺🇸Providence, Rhode Island, United States
Site Reference ID/Investigator# 6589
🇺🇸Greer, South Carolina, United States
Site Reference ID/Investigator# 6586
🇺🇸Goodlettsville, Tennessee, United States
Site Reference ID/Investigator# 7668
🇺🇸Knoxville, Tennessee, United States
Site Reference ID/Investigator# 7671
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 6912
🇺🇸Tyler, Texas, United States
Site Reference ID/Investigator# 7306
🇺🇸Webster, Texas, United States
Site Reference ID/Investigator# 6807
🇺🇸Norfolk, Virginia, United States
Site Reference ID/Investigator# 6801
🇺🇸Seattle, Washington, United States
Site Reference ID/Investigator# 7519
🇺🇸Spokane, Washington, United States
Site Reference ID/Investigator# 7314
🇨🇦Barrie, Canada
Site Reference ID/Investigator# 7452
🇨🇦Calgary, 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# 6708
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7081
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7313
🇨🇦St. John's, Canada
Site Reference ID/Investigator# 7308
🇨🇦Vancouver, Canada
Site Reference ID/Investigator# 6713
🇨🇦Vancouver, Canada
Site Reference ID/Investigator# 7087
🇨🇦Windsor, Canada
Site Reference ID/Investigator# 7312
🇨🇦Westmount, Canada
Site Reference ID/Investigator# 6805
🇨🇦Windsor, Canada
Site Reference ID/Investigator# 7014
🇺🇸Overland Park, Kansas, United States
Site Reference ID/Investigator# 7990
🇺🇸San Francisco, California, United States
Site Reference ID/Investigator# 6915
🇺🇸Nashville, Tennessee, United States
Site Reference ID/Investigator# 8101
🇺🇸Salt Lake City, Utah, United States
Site Reference ID/Investigator# 6579
🇺🇸Birmingham, Alabama, United States
Site Reference ID/Investigator# 6697
🇺🇸Birmingham, Alabama, United States
Site Reference ID/Investigator# 7644
🇺🇸Detroit, Michigan, United States
Site Reference ID/Investigator# 7302
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 6894
🇺🇸Portland, Oregon, United States
Site Reference ID/Investigator# 6578
🇺🇸Portland, Oregon, United States
Site Reference ID/Investigator# 7295
🇺🇸Portland, Oregon, United States
Site Reference ID/Investigator# 6716
🇨🇦Halifax, Canada
Site Reference ID/Investigator# 7317
🇨🇦Surrey, Canada
Site Reference ID/Investigator# 7638
🇨🇦Winnipeg, Canada
Site Reference ID/Investigator# 7451
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 7080
🇺🇸Milwaukee, Wisconsin, United States
Site Reference ID/Investigator# 7015
🇺🇸Huntsville, Alabama, United States
Site Reference ID/Investigator# 6707
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 6582
🇺🇸Alpharetta, Georgia, United States
Site Reference ID/Investigator# 6590
🇺🇸West Palm Beach, Florida, United States
Site Reference ID/Investigator# 6714
🇺🇸Newnan, Georgia, United States
Site Reference ID/Investigator# 8251
🇺🇸Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 6696
🇺🇸Little Rock, Arkansas, United States
Site Reference ID/Investigator# 6728
🇺🇸Scottsdale, Arizona, United States
Site Reference ID/Investigator# 6873
🇺🇸Louisville, Kentucky, United States
Site Reference ID/Investigator# 6917
🇺🇸New Haven, Connecticut, United States
Site Reference ID/Investigator# 6762
🇺🇸Austin, Texas, United States