Clinical trial NCT00570986: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 1465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PGA
timeFrame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
measure: PASI
timeFrame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
measure: PGA
timeFrame: Proportion of subjects maintaining a PGA 0/1 response at Week 52
Secondary outcomes:
measure: DLQI
timeFrame: Change from Baseline in DLQI total score vs. placebo at Week 12
measure: NAPSI
timeFrame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
measure: PASI
timeFrame: Subjects who achieve PASI 90 and 100 at Week 12
measure: Safety parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 6579
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 6697
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 7015
state: Alabama
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 6728
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 6584
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 6696
state: Arkansas
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 6591
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 6710
state: California
city: Irvine
country: United States
facility: Site Reference ID/Investigator# 7885
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 6872
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 7669
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 6821
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 6832
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 7305
state: California
city: San Francisco
country: United States
facility: Site Reference ID/Investigator# 7990
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 6711
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 8139
state: California
city: Vallejo
country: United States
facility: Site Reference ID/Investigator# 7167
state: California
city: Denver
country: United States
facility: Site Reference ID/Investigator# 7302
state: Colorado
city: Longmont
country: United States
facility: Site Reference ID/Investigator# 6921
state: Colorado
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 6917
state: Connecticut
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 6707
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 7301
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 7012
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 6831
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 7016
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 6590
state: Florida
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 6582
state: Georgia
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 7450
state: Georgia
city: Newnan
country: United States
facility: Site Reference ID/Investigator# 6714
state: Georgia
city: Snellville
country: United States
facility: Site Reference ID/Investigator# 6717
state: Georgia
city: Arlington Heights
country: United States
facility: Site Reference ID/Investigator# 7017
state: Illinois
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 7877
state: Illinois
city: Skokie
country: United States
facility: Site Reference ID/Investigator# 6704
state: Illinois
city: West Dundee
country: United States
facility: Site Reference ID/Investigator# 7292
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 6706
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 7646
state: Indiana
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 7014
state: Kansas
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 6873
state: Kentucky
city: Owensboro
country: United States
facility: Site Reference ID/Investigator# 7523
state: Kentucky
city: Andover
country: United States
facility: Site Reference ID/Investigator# 6597
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 6703
state: Massachusetts
city: Detroit
country: United States
facility: Site Reference ID/Investigator# 7644
state: Michigan
city: Fort Gratiot
country: United States
facility: Site Reference ID/Investigator# 6826
state: Michigan
city: Grand Blanc
country: United States
facility: Site Reference ID/Investigator# 7989
state: Michigan
city: Fridley
country: United States
facility: Site Reference ID/Investigator# 6581
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 7890
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6709
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 7451
state: Nebraska
city: Berlin
country: United States
facility: Site Reference ID/Investigator# 7299
state: New Jersey
city: East Windsor
country: United States
facility: Site Reference ID/Investigator# 6924
state: New Jersey
city: New Brunswick
country: United States
facility: Site Reference ID/Investigator# 6577
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 7030
state: New Mexico
city: Buffalo
country: United States
facility: Site Reference ID/Investigator# 7878
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 7876
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 6599
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 6895
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 7637
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 7504
state: New York
city: Stoney Brook
country: United States
facility: Site Reference ID/Investigator# 7018
state: New York
city: Hickory
country: United States
facility: Site Reference ID/Investigator# 6926
state: North Carolina
city: Wilmington
country: United States
facility: Site Reference ID/Investigator# 7293
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 8251
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 6598
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 8082
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 7165
state: Ohio
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 7659
state: Ohio
city: Lake Oswego
country: United States
facility: Site Reference ID/Investigator# 6727
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 6894
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 6578
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 7295
state: Oregon
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 7879
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 6712
state: Pennsylvania
city: Johnston
country: United States
facility: Site Reference ID/Investigator# 6580
state: Rhode Island
city: Providence
country: United States
facility: Site Reference ID/Investigator# 6576
state: Rhode Island
city: Greer
country: United States
facility: Site Reference ID/Investigator# 6589
state: South Carolina
city: Goodlettsville
country: United States
facility: Site Reference ID/Investigator# 6586
state: Tennessee
city: Knoxville
country: United States
facility: Site Reference ID/Investigator# 7668
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 6915
state: Tennessee
city: Arlington
country: United States
facility: Site Reference ID/Investigator# 6825
state: Texas
city: Austin
country: United States
facility: Site Reference ID/Investigator# 6762
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 6822
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 7671
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 6705
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 6708
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7081
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 6912
state: Texas
city: Webster
country: United States
facility: Site Reference ID/Investigator# 7306
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 8101
state: Utah
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 6807
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 6801
state: Washington
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 7519
state: Washington
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 7080
state: Wisconsin
city: Barrie
country: Canada
facility: Site Reference ID/Investigator# 7314
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 7452
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator# 6702
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 6716
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 7309
city: Laval
country: Canada
facility: Site Reference ID/Investigator# 6588
city: London
country: Canada
facility: Site Reference ID/Investigator# 6715
city: London
country: Canada
facility: Site Reference ID/Investigator# 7315
city: Markham
country: Canada
facility: Site Reference ID/Investigator# 7636
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 6699
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 7316
city: North Bay
country: Canada
facility: Site Reference ID/Investigator# 7088
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 7310
city: Quebec City
country: Canada
facility: Site Reference ID/Investigator# 7311
city: St. John's
country: Canada
facility: Site Reference ID/Investigator# 7313
city: Surrey
country: Canada
facility: Site Reference ID/Investigator# 7317
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 7308
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 6713
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 7067
city: Westmount
country: Canada
facility: Site Reference ID/Investigator# 7312
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 7087
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 6805
city: Winnipeg
country: Canada
facility: Site Reference ID/Investigator# 7638
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_CHAIR
References: