Active not recruitingPHASE3INTERVENTIONAL

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

This study is checking a medicine named Bimekizumab over a long period. It's for people who have a condition called axial spondyloarthritis, which includes Ankylosing Spondylitis. This condition causes pain and stiffness, mainly in the spine. Researchers want to see if Bimekizumab is safe when taken for a long time and how well it continues to help with symptoms. This particular study is an extension, meaning it's for individuals who have already participated in earlier studies involving Bimekizumab for the same conditions. By continuing to follow these patients, doctors hope to get a better understanding of the medicine's effects over a longer period.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

508

Start

16 Jun 2020

Estimated completion

07 Aug 2026

Axial Spondyloarthritis Ankylosing Spondylitis r-axSpa Nr-axSpa

What is this study about?

This study is about a medicine called Bimekizumab. It's looking at its effects over a long time in people who have a type of arthritis that mainly affects the spine, called axial spondyloarthritis. This includes two main forms: Ankylosing Spondylitis and non-radiographic axial spondyloarthritis. Both can cause pain, stiffness, and lead to damage in the spine, making daily activities difficult.

The main goal of this research is to see if Bimekizumab is safe and well-tolerated when taken for a long time. It also aims to understand how effective it is in continuing to help people manage their symptoms and live better lives. By collecting long-term information, doctors can learn more about how this medicine works over an extended period. This is important for understanding its full potential in treating these conditions.

This specific study is a continuation for people who have already taken part in previous Bimekizumab studies for axial spondyloarthritis. It's a chance for those participants to keep receiving the medication and for researchers to gather more valuable information. Your participation helps medical science understand better ways to treat these conditions for many others in the future.

Key takeaways

This study is for people already taking Bimekizumab for a type of spinal arthritis.
It aims to check the long-term safety and effectiveness of the medicine.
Participation involves taking the medicine and attending regular check-ups.
It helps doctors understand better treatments for axial spondyloarthritis.
You cannot participate if you are planning a pregnancy soon.

Who may be eligible?

To join this study, you must have already taken part in one of two specific previous Bimekizumab studies (AS0010 or AS0011) for axial spondyloarthritis.

The study doctors also need to believe that you are likely to benefit from continuing in this study. You should be able to understand what's involved, follow the study instructions, and take the medicine as directed.

Quick self-check

Have I already taken part in Bimekizumab studies AS0010 or AS0011?
Do I feel capable of understanding and following study instructions?
Am I planning a pregnancy (or a partner's pregnancy) in the near future (within 20 weeks of treatment ending)?
Have I had serious infections or side effects in previous studies that are still ongoing or未resolved?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Since this is an extension study, if you participated in the previous studies (AS0010 or AS0011), you would continue to receive Bimekizumab. You'd have regular check-ups with the study team. These visits would likely involve answering questions about your health, filling out questionnaires, and possibly having blood tests or other assessments to check how the medicine is affecting you. The exact number and timing of visits would be explained by the study team. You'd need to take the study medicine as instructed. The total duration of your participation would be discussed upon entry into the study.

Potential risks and benefits

Participating in this study might offer a chance to continue receiving a medicine that could help manage your axial spondyloarthritis symptoms over a longer period. However, like all medicines, Bimekizumab can have side effects, and some may be serious. The study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (75)

As0014 50062
Glendale, United States
As0014 50052
Phoenix, United States
As0014 50060
Upland, United States
As0014 50059
Ormond Beach, United States
As0014 50056
Sarasota, United States
As0014 50015
Hagerstown, United States
As0014 50016
St Louis, United States
As0014 50055
Portland, United States
As0014 50020
Duncansville, United States
As0014 50057
Dallas, United States
As0014 40004
Brussels, Belgium
As0014 40003
Genk, Belgium

+63 more sites — see the official record for the full list.

Common questions

What is axial spondyloarthritis?

It's a long-term condition that mainly causes pain and stiffness in your spine and sometimes other joints.

What is Bimekizumab?

It's a medicine being studied to see if it can help people with axial spondyloarthritis.

Why is this study only for people who were in other studies?

This study is designed to follow people for a longer time who have already started Bimekizumab in a previous study, to see its long-term effects.

Will I get the actual medicine or a dummy treatment?

Because this is an extension study, you would continue to receive Bimekizumab if you join.

What if I get pregnant or want to have a baby during the study?

Women planning pregnancy during the study or shortly after, and men planning a partner's pregnancy during the study, cannot participate due to potential risks to an unborn baby.