Conditions: Moderate to Severe Plaque Psoriasis
Keywords: psoriasis, brodalumab, AMG 827
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1831
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Detailed description:
.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.

Arms:
arm 1: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 2: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 3: Administered by subcutaneous (SC) injection per the labeled dosing regimen. arm 4: Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: ustekinumab intervention 4: placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered SC intervention 2: 140 mg brodalumab administered SC intervention 3: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. intervention 4: Placebo administered SC

Protocol document: