AuthorisedTherapeutic confirmatory (Phase III)Interventional

Evaluation of the efficacy and safety of bimekizumab (BZK) or adalimumab (ADA) in the treatment of anterior chest wall pain associated with active axial spondyloarthritis refractory to NSAIDs with hypothesis of superiority of bimekizumab. Randomized, open-label, in parallel arms, head to head trial (ThoracSPA)

This clinical trial is designed for adults who have a type of arthritis called axial spondyloarthritis, which causes pain and stiffness, especially in the back or chest area. It’s for those whose current anti-inflammatory pain relief (NSAIDs) isn't enough. The study compares two different medicines, Bimzelx (bimekizumab) and adalimumab, to see which is more effective and safer in relieving pain and improving how people feel and function in their daily lives. Researchers are particularly interested in how well these medicines reduce pain in the front of the chest. The study wants to find out if Bimzelx might be better than adalimumab. Participants will receive one of these medicines, and their progress will be carefully monitored over several months.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

150

Start

03 Apr 2026

axial or predominantly axial SpA with or without psoriasis

What is this study about?

This study is looking at new ways to treat a type of arthritis called axial spondyloarthritis (sometimes shortened to axSpA). This condition mainly affects the spine and can cause long-lasting pain, stiffness, and discomfort, especially in the back. For some people, it also causes pain in the front of the chest, which can be very troublesome. If you've been diagnosed with axial spondyloarthritis and your usual anti-inflammatory medicines (like ibuprofen) aren't making enough of a difference, this study might be relevant to you.

The main goal of this research is to compare two treatments: Bimzelx (bimekizumab) and adalimumab. Both are 'biologic' medicines, which work differently from standard pain relief by targeting specific parts of the immune system that cause inflammation. The study wants to see which of these two medicines is better at reducing pain, especially chest pain, and improving overall well-being and daily activities for people with axSpA. Researchers are hoping that Bimzelx might offer a better outcome for patients.

Over a period of six months, participants will receive either Bimzelx or adalimumab. The research team will regularly check how much pain they have, especially in the chest, and how well they are moving and feeling. This will help them understand how effective each treatment is and if one is clearly better than the other. Understanding which treatment works best can help doctors make more informed decisions about how to best treat their patients in the future.

Key takeaways

This study compares two biologic medicines, Bimzelx and adalimumab, for axial spondyloarthritis.
It's for adults whose back or chest pain isn't helped enough by standard pain relief.
The main aim is to see which medicine is better at reducing pain, especially chest pain.
Participants will receive one of the two medicines and be monitored for six months.
The study aims to improve future treatment options for people with axSpA.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You must have been diagnosed with axial spondyloarthritis, which means you have ongoing pain and stiffness, mainly in your back or sometimes also in your chest.

Importantly, the study is for people whose current pain relief, like standard anti-inflammatory drugs (NSAIDs), isn't working well enough to control their symptoms. You don't need to have psoriasis (a skin condition) to take part, but people with psoriasis who also have axial spondyloarthritis can also be included.

The research team will need to check your full medical history and current health to make sure that the study medicines are suitable and safe for you. This will involve some medical tests and discussions with the study doctors.

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?
Are you experiencing pain in your back or chest related to this condition?
Are your current anti-inflammatory medicines (like ibuprofen) not fully managing your pain?
Are you willing to attend regular clinic visits and record your symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to receive one of two medicines: Bimzelx or adalimumab. You won't get to choose which one. Both medicines are given as an injection, using a pre-filled syringe. You'll be shown exactly how to do this or it can be given by a healthcare professional.

The study will last for at least six months. During this time, you'll have regular visits to the clinic so the medical team can monitor your progress, check for any side effects, and make sure the medicine is working. You'll also be asked to regularly record your chest pain levels using a special digital tool on different days and times each week. This will help the researchers track how your pain changes over time. There will be initial screening appointments, regular check-ups during the treatment phase, and follow-up assessments to gather all necessary information.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new or effective treatment for your condition, which could reduce your pain and improve your quality of life. You'll also receive careful medical attention and monitoring throughout the study. However, there are potential risks, including side effects from the medicines, which will be fully explained to you before you agree to take part. 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 (1)

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

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Unverified
France

Common questions

What is axial spondyloarthritis (axSpA)?

Axial spondyloarthritis is a type of arthritis that mainly causes pain and stiffness in the spine, and sometimes in other joints like the chest area.

What are Bimzelx and adalimumab?

These are 'biologic' medicines that work by calming down the immune system to reduce inflammation, which helps ease the symptoms of axSpA.

Will I know which medicine I'm getting?

No, this study is 'open-label,' meaning both you and the study team will know which medicine you receive to compare their effects directly.

How often will I need to visit the clinic?

You'll have regular scheduled visits over six months for check-ups and to monitor your progress. The exact schedule will be shared if you are eligible.

What if I feel worse during the study?

Your health will be closely monitored, and you can withdraw from the study at any time if you feel it's not right for you or if your condition changes. You will always have access to standard medical care.