The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,831
210 mg brodalumab administered SC
140 mg brodalumab administered SC
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Time frame: 12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
Time frame: 12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Time frame: 12 Weeks
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Placebo administered SC
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Bakersfield, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Irvine, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
...and 143 more locations