A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, RISANKIZUMABCONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN ADULT STUDY PARTICIPANTS WITH ACTIVE PSORIATIC ARTHRITIS
Psoriatic arthritis causes painful, stiff, and swollen joints alongside red, scaly skin patches. This Phase 3 clinical trial is comparing a medicine called bimekizumab against an already approved treatment named Skyrizi (risankizumab) and an inactive dummy injection (placebo). The main goal is to find out if bimekizumab can improve joint symptoms by at least half within 16 weeks of treatment. Researchers also want to see how well it clears skin psoriasis and improves daily living, as well as tracking any unwanted side effects. Participants will be adults aged 18 or older with active psoriatic arthritis. Neither you nor your study doctor will know which treatment you receive at the start, ensuring the test is completely fair. Taking part helps doctors understand if bimekizumab offers a better option for people living with this chronic condition.
At a glance
What is this study about?
Psoriatic arthritis is a long-term condition where the immune system mistakenly attacks the joints and the skin. This leads to pain, stiffness, fatigue, and red, flaky skin patches known as psoriasis. While several treatments exist, they do not work well for everyone, leaving many people searching for better relief from flare-ups and joint damage.
This clinical study is evaluating a medicine called bimekizumab. Bimekizumab works by calming specific proteins in the immune system that cause inflammation. To see how well it works, researchers are directly comparing it against another modern treatment called Skyrizi (risankizumab), as well as a harmless dummy injection containing saltwater (placebo).
By testing these medicines side by side, researchers hope to see if bimekizumab brings faster and deeper relief for both joint inflammation and skin patches. The findings could give patients and NHS doctors another effective choice for managing active psoriatic arthritis in the future.
Key takeaways
- The study tests bimekizumab against an existing medicine (Skyrizi) and a dummy injection.
- It aims to improve joint pain, stiffness, and skin patches in active psoriatic arthritis.
- Open to adults aged 18 and older with active symptoms.
- The main check on how well the treatment works takes place at 16 weeks.
- You will receive close medical monitoring and can leave the trial at any time.
Who may be eligible?
This study is open to men and women aged 18 and older who have been diagnosed with active psoriatic arthritis. Having 'active' disease means your joints are currently painful, stiff, or swollen despite any standard medications you may have already tried.
People who also have skin psoriasis covering small or larger areas of their body may take part. The study team will assess your overall health, medical history, and current joint symptoms to see if the trial is safe and appropriate for you.
You might not be eligible if you have certain active infections, other severe long-term medical conditions, or if you are taking specific medications that could clash with the study drugs. The trial doctor will explain all safety requirements before you decide to join.
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.
- I am at least 18 years old.
- I have a confirmed diagnosis of psoriatic arthritis.
- I currently have painful, stiff, or swollen joints.
- I am willing to attend regular hospital clinic visits.
- I am comfortable receiving injections under the skin.
What does participation involve?
If you decide to take part, you will attend regular appointments at a specialist hospital clinic. Before treatment starts, the team will perform health checks, including blood tests, physical examinations, and detailed joint assessments.
During the study, you will receive the study medicine as an injection just under the skin using a pre-filled syringe. Because this is a blinded trial, you will be randomly chosen to receive bimekizumab, Skyrizi, or a dummy injection, and neither you nor your doctor will choose which one you get. You will have clinic visits every few weeks to check your joints, examine your skin, and discuss how you are feeling. The initial main assessment happens at week 16, and your total time in the trial will be clearly outlined by the clinic team.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedCzechia
Common questions
What is bimekizumab?
Bimekizumab is an injection that targets and blocks specific inflammatory signals in the body to reduce joint swelling and clear skin psoriasis.
Will I definitely receive the new medicine?
No. A computer will randomly assign you to receive bimekizumab, Skyrizi, or an inactive dummy jab so that researchers can fairly compare the results.
Will taking part cost me anything?
No. The trial medicine, clinic visits, and all tests are provided free of charge, and travel expenses to and from the clinic are usually covered.
Can I leave the trial if I change my mind?
Yes. Taking part is entirely voluntary, and you can withdraw at any point without it affecting your ongoing NHS treatment.
What happens if my arthritis gets worse during the trial?
The trial doctors will check your joints regularly. If your symptoms get worse, they can safely switch your treatment to protect your health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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