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.
This study 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
1,881
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 Psoriasis Area Severity Index (PASI) 75 at Week 12
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Time frame: 12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 \[clear\] to 5 \[severe\]). Success was defined by a score of 0 or 1 (clear to almost clear).
Time frame: 12 weeks
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placebo administered SC
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Beverly Hills, California, United States
Research Site
Burbank, California, United States
Research Site
Encino, California, United States
Research Site
Fremont, California, United States
Research Site
Fullerton, California, United States
Research Site
Irvine, California, United States
Research Site
Los Angeles, California, United States
...and 147 more locations