RecruitingPHASE1INTERVENTIONAL

A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

This research is investigating a medicine called bimekizumab for adults suffering from psoriatic arthritis or axial spondyloarthritis (a type of long-term back pain). The main aim is to understand if giving bimekizumab by a drip (into a vein) works just as well and safely as giving it by an injection under the skin. Researchers want to compare how the medicine moves through the body and how long it stays there when given in these different ways. This is a very early-stage study (Phase 1), focusing on safety and how the body handles the medicine, rather than its effectiveness in treating the conditions. The results could help doctors decide the best way to give this treatment in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

UCB Biopharma SRL

Enrolment target

392

Start

10 Dec 2025

Estimated completion

14 Sep 2028

Psoriatic Arthritis Axial Spondyloarthritis

What is this study about?

This study is about a medicine called bimekizumab, which is used to treat conditions like psoriatic arthritis and axial spondyloarthritis. Psoriatic arthritis affects your joints and can cause swelling, stiffness, and pain, often alongside a skin condition called psoriasis. Axial spondyloarthritis mainly affects the spine and can cause long-term back pain and stiffness.

The main goal of this particular study is to compare different ways of giving bimekizumab. Some people will receive it through a drip into their vein (this is called intravenous), and others will receive it as an injection under the skin. The researchers want to see if the medicine behaves similarly in the body and is equally safe, regardless of how it's given. This is an important step to make sure that future treatments are as effective and easy to manage as possible.

This is an early-stage study, which means the focus is on understanding how the body handles the medicine and checking for any side effects, rather than how well it treats the diseases. By carefully studying how bimekizumab moves through the body in different forms, researchers can gather important information that will help in developing the best ways to use this medicine for patients in the future.

Key takeaways

This study is testing a medicine called bimekizumab for psoriatic arthritis and axial spondyloarthritis.
It aims to compare two ways of giving the medicine: by drip (into a vein) and by injection (under the skin).
The main goals are to check safety and how the medicine moves through the body.
It's an early-stage study (Phase 1) focused on understanding the medicine.
Participants will have regular health checks and blood tests.
You can withdraw from the study at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You must have either active psoriatic arthritis or axial spondyloarthritis that your doctor thinks could be treated with bimekizumab. There are also weight requirements: women should weigh between 45 kg and 100 kg, and men between 50 kg and 100 kg.

It's important that you haven't taken certain other types of similar medicines (called 'biologic disease-modifying anti-rheumatic drugs' or bDMARDs) recently. If you have, you'll need to have stopped them for at least three months, or for a specific time frame depending on the medicine.

You cannot join if you have serious problems with your other organs like your heart, liver, or kidneys. You also can't take part if you've had severe mental health issues, drug or alcohol problems in the last year, or if you have certain infections like tuberculosis. Other inflammatory conditions like rheumatoid arthritis or lupus, or recent vaccinations, would also prevent you from joining.

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?
Do you have active psoriatic arthritis or axial spondyloarthritis?
Do you weigh between 45-100 kg (if female) or 50-100 kg (if male)?
Have you avoided certain other arthritis medicines (bDMARDs) recently, or stopped them for long enough?
Do you have any serious heart, kidney, liver, or breathing problems?
Have you had serious infections (like TB) or certain vaccines recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medicine, bimekizumab, in one of the ways being tested – either through a drip into a vein or as an injection under the skin. You would have regular appointments at the clinic for health checks, blood tests, and to make sure the medicine is safe for you. These visits would allow the research team to carefully monitor how your body is reacting to the treatment and how the medicine is moving through your system. The total duration of your involvement in the study, including follow-up, would be carefully explained to you by the study team.

Potential risks and benefits

Participating in this study might offer you access to a new treatment for your condition under close medical supervision. However, like all medicines, bimekizumab can have side effects, which the research team will explain to you in detail. There's also a chance the medicine may not help your symptoms. The information gathered from this study could help future patients, even if it doesn't directly benefit you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

Pa0019 114
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Peoria, United States· Recruiting
Pa0019 127
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Apple Valley, United States· Recruiting
Pa0019 111
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Covina, United States· Recruiting
Pa0019 117
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Riverside, United States· Recruiting
Pa0019 125
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San Leandro, United States· Recruiting
Pa0019 126
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Temecula, United States· Recruiting
Pa0019 141
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Upland, United States· Recruiting
Pa0019 120
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Whittier, United States· Recruiting
Pa0019 128
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Whittier, United States· Recruiting
Pa0019 123
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Fort Collins, United States· Recruiting
Pa0019 143
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Ormond Beach, United States· Recruiting
Pa0019 113
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South Miami, United States· Recruiting

Common questions

What is bimekizumab?

Bimekizumab is a medicine being studied for conditions like psoriatic arthritis and a type of back pain called axial spondyloarthritis. It works by targeting specific parts of your immune system that cause inflammation.

What does 'Phase 1' study mean?

A Phase 1 study is an early stage of clinical research. Its main purpose is to test the safety of a new medicine or treatment and see how it moves through the body in a small number of people, rather than how well it treats the condition.

What's the difference between intravenous (iv) and subcutaneous (sc) administration?

Intravenous (iv) means the medicine is given directly into a vein through a drip. Subcutaneous (sc) means it's given as an injection just under the skin, usually with a small needle.

Will this study cure my condition?

This study is not designed to find a cure. It's focused on understanding how bimekizumab works in the body and its safety when given in different ways, which is an important step in developing new treatments for your condition.

What if I experience side effects?

The study team will carefully monitor you for any side effects. If you experience anything unusual or concerning, you should tell the study team immediately so they can provide appropriate care.

How to find out more

UCB Cares

ucbcares@ucb.com +18445992273 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.