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: | August 2012 |
End Date: | August 2015 |
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-2
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.
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
We found this trial at
59
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