NCT02429882

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Brodalumab 210 mg	210 mg brodalumab will be administered subcutaneously
DRUG	Placebo	Placebo will be administered subcutaneously

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-04-29
• Last updated: 2015-06-19

Locations

5 sites across 2 countries: United States, Canada