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



Status:Terminated
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:12/13/2017
Start Date:September 2012
End Date:October 2015

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A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

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.


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
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