Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

Launched by BAUSCH HEALTH AMERICAS, INC. · Oct 15, 2012

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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