NCT03928743

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (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 efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Bimekizumab	Subjects will receive bimekizumab at pre-specified time-points.
OTHER	Placebo	Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Timeline

• Start date: 2019-04-25
• Primary completion: 2021-09-03
• Completion: 2022-08-08
• First posted: 2019-04-26
• Last updated: 2025-12-24
• Results posted: 2024-10-10

Locations

83 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