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Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Psoriatic Arthritis

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 Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often occurring in people who have psoriasis, a skin condition that leads to red, scaly patches. The medication being tested, bimekizumab, is given as an injection under the skin and is designed to help manage the symptoms of this condition.

The purpose of the study is to assess how safe and tolerable bimekizumab is when used over an extended period. Participants in the study will receive regular injections of bimekizumab and will be monitored to see how their condition responds to the treatment. The study will also track any side effects that may occur during the treatment period.

Throughout the study, participants will have regular check-ups to evaluate their health and the effectiveness of the treatment. The study aims to provide valuable information on the long-term use of bimekizumab for managing Psoriatic Arthritis, helping to determine if it is a safe and effective option for patients with this condition.

The research process

The trial runs in 5 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, the participant is required to have completed a previous study without meeting any withdrawal criteria.

    Female participants must be postmenopausal, permanently sterilized, or willing to use a highly effective method of contraception.

  2. Step 2

    Treatment administration

    The participant will receive bimekizumab, which is a solution for injection.

    The medication is administered through subcutaneous use, meaning it is injected under the skin.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will be monitored for any treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

    The study aims to assess the long-term safety and tolerability of bimekizumab in treating active psoriatic arthritis.

  4. Step 4

    Evaluation of treatment response

    The participant's response to treatment will be evaluated at various intervals, including weeks 24, 52, and 140.

    Assessments will include measures such as the American College of Rheumatology (ACR) improvement criteria and the Psoriasis Area Severity Index (PASI).

  5. Step 5

    Study completion

    The study is estimated to end on May 19, 2026.

    Upon completion, the participant's overall health and response to the treatment will be reviewed.

Who can join the trial?

6 criteria

  • The person must have **Psoriatic Arthritis**, which is a type of arthritis that affects some people who have the skin condition psoriasis.
  • The person should be expected to benefit from participating in this study, according to the study doctor.
  • The person must have completed a previous study, identified as PA0010 or PA0011, without needing to leave the study early for any reason.
  • Female participants must either be postmenopausal (which means they have stopped having periods), permanently sterilized (which means they cannot have children), or willing to use a very effective form of birth control.
  • Both men and women can participate in the study.
  • The study is for adults, which generally means people who are 18 years or older.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means you must be 18 years or older.
  • Patients who do not have psoriatic arthritis cannot participate. Psoriatic arthritis is a condition that affects the joints and is often associated with a skin condition called psoriasis.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or people who might not be able to make decisions for themselves.
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Investigated drugs

Bimekizumab is a medication used in this clinical trial to treat adults with active psoriatic arthritis. It is administered through an injection under the skin. The purpose of using bimekizumab in this study is to evaluate its long-term safety and how well patients can tolerate it. Additionally, the trial aims to understand how effective bimekizumab is in managing the symptoms of psoriatic arthritis over an extended period.

What is already known about the treatment

Bimekizumab – Bimekizumab is administered through subcutaneous injection and is currently being studied in clinical trials for its long-term safety and effectiveness in treating psoriatic arthritis. It is an investigational medication, meaning it is still under research and not yet fully approved for widespread use. The main therapeutic indication for bimekizumab is psoriatic arthritis, a condition characterized by joint inflammation and skin lesions. At the molecular level, bimekizumab works by inhibiting specific proteins in the immune system that contribute to inflammation, helping to reduce symptoms. It is classified pharmacologically as a monoclonal antibody targeting interleukin pathways involved in inflammatory processes.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals who have psoriasis, a skin condition characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, often affecting fingers and toes, leading to a sausage-like appearance known as dactylitis. Over time, psoriatic arthritis can lead to joint damage and reduced range of motion. The condition may also involve inflammation where tendons and ligaments attach to bones, known as enthesitis. Symptoms can vary in severity and may come and go, with periods of flare-ups and remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506528-95-00Protocol codePA0012Estimated enrolment1 212 patientsSponsorUCB Biopharma

sourced from the EU Clinical Trials Register and site verification

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