Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Open-Label Extension Study to Assess 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

This research study is checking the long-term effects of a medicine called bimekizumab for people suffering from a condition called axial spondyloarthritis. This condition causes pain and stiffness, mainly in the spine. The study wants to see how safe the medicine is over time and if it continues to help people feel better. Researchers will carefully watch for any side effects and how much the medicine improves symptoms like pain and stiffness. It's a follow-up study for people who have already been taking bimekizumab in previous trials, giving us more information on its long-term use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

UCB Biopharma

Enrolment target

568

Start

02 Jul 2024

Axial Spondyloarthritis

What is this study about?

This study is a follow-up for people who have already been taking a medicine called bimekizumab in earlier research. The main goal is to understand how safe this medicine is over a longer period and if it continues to help people with axial spondyloarthritis. Axial spondyloarthritis is a type of arthritis that mainly affects the spine, causing pain, stiffness, and sometimes damage.

Researchers will be carefully tracking any unexpected effects (known as 'adverse events') that people experience while taking the medicine. They'll also be looking at how well the medicine continues to reduce symptoms like pain and stiffness, and if it helps people move more easily. This extended study is important because it gives doctors and patients a better idea of what to expect from bimekizumab if it's used for many months or even years.

By gathering this long-term information, the study aims to confirm whether bimekizumab is a good and lasting treatment option for axial spondyloarthritis. This helps doctors make informed decisions and gives people living with this condition more options for managing their symptoms and improving their quality of life.

Key takeaways

This study is for adults with axial spondyloarthritis.
It's a long-term follow-up for people already using bimekizumab.
The main goals are to check the medicine's safety and how well it continues to work.
You'll have regular medical checks and assessments if you join.
Both potential benefits and risks are considered.
You can leave the study at any time.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. This study is for people who have already taken part in earlier research studies involving the medicine bimekizumab.

Both men and women can join. The study is specifically for individuals who have been diagnosed with axial spondyloarthritis, which includes conditions like ankylosing spondylitis or non-radiographic axial spondyloarthritis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with axial spondyloarthritis (including ankylosing spondylitis or non-radiographic axial spondyloarthritis)?
Have you previously taken part in an earlier study with bimekizumab?
Are you willing to attend regular clinic visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive the medicine bimekizumab. You will need to attend regular visits to the study clinic for assessments. These visits will involve doctors checking your health, asking about any symptoms or side effects you might be having, and possibly taking blood samples or performing other tests.

Throughout the study, researchers will be carefully monitoring how well the medicine is working and how your body is reacting to it. The length of your participation can vary, as the study aims to gather long-term information. You should expect regular check-ups over an extended period, which could be for a few years, to track your progress and safety.

Potential risks and benefits

Participating in this study might offer potential benefits, such as continuing to receive a treatment that could help manage your axial spondyloarthritis symptoms under close medical supervision. However, like all medicines, bimekizumab can have side effects, and you might experience new or unexpected ones. Serious side effects, although rare, are possible. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Poland
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Unverified
France
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Unverified
Belgium
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Unverified
Czechia
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Unverified
Spain
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Unverified
Germany

Common questions

What is axial spondyloarthritis?

It's a type of arthritis that mainly causes long-lasting pain and stiffness in the spine and sometimes other joints.

What is bimekizumab?

Bimekizumab is a medicine being studied as a treatment for conditions like axial spondyloarthritis.

What does 'long-term safety' mean?

It means the study will check if the medicine remains safe to use over many months or even years, and what side effects might show up over time.

Will taking part in this study cure my condition?

No, this study aims to see if the medicine helps manage symptoms and improves your condition, not to cure it.

Do I have to pay to join the study?

No, clinical trials usually cover the costs of study medicine and study-related visits.