Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab (AMG 827) 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, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
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.
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.
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
We found this trial at
33
sites
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