NCT01708603

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,831 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

.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.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	210 mg brodalumab	210 mg brodalumab administered SC
DRUG	140 mg brodalumab	140 mg brodalumab administered SC
DRUG	ustekinumab	45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
DRUG	placebo	Placebo administered SC

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-09-01
• Completion: 2015-10-01
• First posted: 2012-10-17
• Last updated: 2020-01-06
• Results posted: 2020-01-06

Locations

153 sites across 11 countries: United States, Australia, Austria, Canada, Czechia, France, Hungary, Netherlands, Poland, Portugal, Spain