The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
661
210 mg brodalumab administered subcutaneous (SC)
140 mg brodalumab administered subcutaneous (SC)
Placebo administered subcutaneous (SC)
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
Time frame: 0-12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear \[0\] or almost clear \[1\]) on the static physicians global assessment (sPGA) at week 12
Time frame: 0 - 12 Weeks
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear\[0\] or almost clear \[1\]) at week 52.
Time frame: Week 0 - Week 52
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Research Site
Phoenix, Arizona, United States
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Bakersfield, California, United States
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Encino, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Ramon, California, United States
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Santa Monica, California, United States
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Alpharetta, Georgia, United States
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West Dundee, Illinois, United States
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