P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Bausch Health Americas, Inc.
• Treatments: Antibodies, Monoclonal; Brodalumab; Ustekinumab

Criteria

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