NCT02029495

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Detailed description

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	210 mg brodalumab	210 mg brodalumab administered via subcutaneous injection
DRUG	140 mg brodalumab	140 mg brodalumab administered via subcutaneous injection
DRUG	Placebo	Placebo administered via subcutaneous injection until week 24.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-01-08
• Last updated: 2017-05-19
• Results posted: 2017-05-19

Locations

152 sites across 17 countries: United States, Belgium, Bulgaria, Canada, Czechia, Estonia, France, Greece, Hungary, Italy, Mexico, Poland, Russia, Slovakia, Spain, Switzerland, United Kingdom