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Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Axial Spondyloarthritis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a medication called bimekizumab in adults with a condition known as Axial Spondyloarthritis. This condition is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing inflammation and pain. The study also includes participants with specific forms of this condition, such as Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis.

The purpose of the study is to assess how safe and tolerable bimekizumab is over a long period. Participants will receive bimekizumab as a solution for injection, which is administered under the skin. The study will monitor participants for any side effects and how well they tolerate the medication. The study will also evaluate the effectiveness of bimekizumab in managing symptoms of the disease over time.

Participants in the study will be observed for changes in their condition at various intervals, such as weeks 28, 52, and 112. The study aims to gather information on the incidence of any adverse events and the overall impact of the treatment on the participants' quality of life and disease activity. This information will help determine the long-term benefits and risks of using bimekizumab for treating Axial Spondyloarthritis and its related conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be assessed to ensure you meet the necessary criteria. This includes confirming that you have completed a previous study and are considered reliable and capable of following the study protocol.

  2. Step 2

    Receiving medication

    You will receive the medication bimekizumab, which is a solution for injection. The medication is administered through a method called subcutaneous use, meaning it is injected under the skin.

  3. Step 3

    Medication schedule

    The specific dosage and frequency of the medication will be determined by the study protocol. It is important to adhere to the schedule provided by the study team.

  4. Step 4

    Regular check-ups

    You will have regular visits to monitor your health and the effects of the medication. These visits will include assessments to ensure the medication is safe and effective for you.

  5. Step 5

    Monitoring side effects

    Throughout the study, any side effects or adverse events will be closely monitored. This is to ensure your safety and to understand how the medication affects you.

  6. Step 6

    Assessments at specific weeks

    At weeks 28, 52, and 112, specific assessments will be conducted to evaluate your response to the medication. These assessments will measure improvements in your condition and any changes in your quality of life.

  7. Step 7

    Completion of the study

    Upon completing the study, a final assessment will be conducted to gather comprehensive data on your experience and the long-term effects of the medication.

Who can join the trial?

5 criteria

  • The study participant must be considered reliable and capable of following the study plan. This means they should be able to understand and complete questionnaires, attend scheduled visits, and take medication as instructed by the study doctor.
  • In the opinion of the study doctor, the participant is expected to benefit from being part of this study.
  • The participant must have completed a previous study identified as AS0010 or AS0011.
  • Participants can be of any gender.
  • Participants should be adults, typically aged 18 years and older.

Who cannot join the trial?

3 criteria

  • Patients who do not have active axial spondyloarthritis cannot participate. This is a condition affecting the spine and joints.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Bimekizumab is a medication used in this clinical trial to help people with certain types of arthritis, specifically axial spondyloarthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis. These conditions cause inflammation in the spine and other joints, leading to pain and stiffness. Bimekizumab works by blocking specific proteins in the body that are involved in the inflammation process. By doing this, it aims to reduce the symptoms of these conditions, such as pain and swelling, and improve the overall quality of life for patients. The trial is focused on understanding how safe and tolerable this medication is when used over a long period.

What is already known about the treatment

Bimekizumab – Bimekizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating axial spondyloarthritis, including ankylosing spondylitis and nonradiographic axial spondyloarthritis. This medication works by targeting specific proteins in the body that are involved in inflammation, helping to reduce symptoms associated with these conditions. Bimekizumab is classified as a monoclonal antibody, a type of drug designed to interact with the immune system to manage inflammatory diseases.

Investigated diseases

Axial Spondyloarthritis – Axial Spondyloarthritis is a chronic inflammatory disease primarily affecting the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by inflammation that can lead to pain and stiffness, particularly in the lower back and buttocks. Over time, the inflammation may cause new bone formation, leading to the fusion of the vertebrae, which can reduce flexibility and mobility. The disease often begins in early adulthood and can progress slowly, with periods of increased symptoms and periods of remission. In some cases, it may also affect other joints and organs, such as the eyes and skin. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506527-28-00Protocol codeAS0014Estimated enrolment691 patientsSponsorUCB Biopharma

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