Clinical trial NCT00292396: Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 180
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 the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion Criteria:

* Subject had previously received systemic or biologic 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 injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: Proportion of subjects with clinical response relative to Baseline PASI score
timeFrame: Week 12, Week 40 and Week 60
Secondary outcomes:
measure: Quality of Life Surveys
timeFrame: Week 12, Week 48 and Week 60
measure: Clinical response indicators
timeFrame: Week 12, Week 48 and Week 60
measure: Safety parameters
timeFrame: Monthly through duration of study
measure: PGA Assessment
timeFrame: Week 12, Week 40 and Week 60
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 3351
state: California
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 3347
state: Georgia
city: Skokie
country: United States
facility: Site Reference ID/Investigator# 3348
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 993
state: Indiana
city: Boston
country: United States
facility: Site Reference ID/Investigator# 990
state: Massachusetts
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 3349
state: Missouri
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 992
state: Ohio
city: Lake Oswego
country: United States
facility: Site Reference ID/Investigator# 991
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 3367
state: Oregon
city: Johnston
country: United States
facility: Site Reference ID/Investigator# 3346
state: Rhode Island
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 994
state: Tennessee
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 3350
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 796
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 2081
state: Utah
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 3366
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 989
state: Washington
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 3361
city: Laval
country: Canada
facility: Site Reference ID/Investigator# 985
city: London
country: Canada
facility: Site Reference ID/Investigator# 987
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 3364
city: North Bay
country: Canada
facility: Site Reference ID/Investigator# 794
city: Quebec City
country: Canada
facility: Site Reference ID/Investigator# 988
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 795
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 3360
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_CHAIR
References:
citation: Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63.