P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

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

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.

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
Placebo	210 mg brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
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.
Placebo	placebo	Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
ustekinumab	ustekinumab	Administered by subcutaneous (SC) injection per the labeled dosing regimen.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12	12 Weeks	to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	12 weeks	Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	12 weeks	to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.