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

• 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 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.

• 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