NCT01708590

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 661 (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 taken every two weeks at two different doses.

Detailed description

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	210 mg brodalumab	210 mg brodalumab administered subcutaneous (SC)
DRUG	140 mg brodalumab	140 mg brodalumab administered subcutaneous (SC)
DRUG	placebo	Placebo administered subcutaneous (SC)

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-05-01
• Completion: 2015-08-01
• First posted: 2012-10-17
• Last updated: 2020-01-03
• Results posted: 2020-01-03

Locations

78 sites across 6 countries: United States, Canada, France, Germany, Poland, Switzerland