NCT04436640

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Conditions

• Axial Spondyloarthritis
• Ankylosing Spondylitis
• r-axSpa
• Nr-axSpa

Interventions

Type	Name	Description
DRUG	Bimekizumab	Subjects will receive bimekizumab at prespecified time-points.

Timeline

• Start date: 2020-06-16
• Primary completion: 2026-08-07
• Completion: 2026-08-07
• First posted: 2020-06-18
• Last updated: 2026-03-27

Locations

75 sites across 14 countries: United States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study