Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

Phase 3

Terminated

Interventions: Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: placebo

Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject has had stable moderate to severe plaque psoriasis for at least 6 months
Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
Subject has known history of Crohn's disease
Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
Subject has stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used any anti-IL-17 biologic therapy

Arm && Interventions

Group	Intervention	Description
210 mg brodalumab	placebo	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
140 mg brodalumab	placebo	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
placebo	210 mg brodalumab	Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
placebo	placebo	Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
140 mg brodalumab	140 mg brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
210 mg brodalumab	210 mg brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12	0-12 weeks	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.
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	0 - 12 Weeks	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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Week 0 - 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.