Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

Phase 3

Terminated

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

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject has had stable moderate to severe plaque psoriasis for at least 6 months
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 not stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Arm && Interventions

Group	Intervention	Description
210 mg brodalumab	210 mg brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab	140 mg brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
ustekinumab	ustekinumab	Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Placebo	placebo	Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Placebo	210 mg brodalumab	Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Primary Outcome Measures

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

Secondary Outcome Measures