A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
This study is an extension of previous research into a new medicine called sonelokimab for people with psoriatic arthritis. Psoriatic arthritis is a condition that causes joint pain and swelling, often alongside a skin rash. This phase of the study is designed to see how safe the medicine is and how well it works over a longer period. People taking part have already received sonelokimab in an earlier study. Doctors will be carefully checking for any side effects, including serious ones, and looking at how the medicine affects blood tests, heart health, and overall well-being. The main goal is to gather more information on the long-term effects of sonelokimab.
At a glance
What is this study about?
You might have heard about clinical trials, which are research studies that test new medicines or treatments. This particular study is for a new medicine called sonelokimab, which is being investigated as a treatment for psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a skin condition. It can cause joint pain, stiffness, and swelling in various parts of the body.
This study is called an 'open-label extension study', which means it's a follow-on study for people who have already taken part in a previous trial for sonelokimab. 'Open-label' means that both you and your doctor will know you are receiving sonelokimab. The main purpose of this study is to gather more information about the medicine's long-term effects, focusing on how safe it is and if it continues to help with symptoms over an extended period.
Researchers will be carefully tracking various aspects of your health throughout the study. This includes looking for any side effects, changes in your blood tests, monitoring your heart (using an ECG, which checks your heart's electrical activity), and checking your vital signs like blood pressure. The information gathered will help doctors understand more about sonelokimab and whether it could be a helpful long-term treatment option for psoriatic arthritis.
Key takeaways
- This study is testing a new medicine called sonelokimab for psoriatic arthritis.
- It's an extension study for people who were in a previous sonelokimab trial.
- The main goal is to check the medicine's long-term safety and how well it continues to work.
- Participants will have regular medical check-ups, blood tests, and heart monitoring.
- You must be 18 years or older and have psoriatic arthritis to be considered for this study.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
An important requirement is that you must have already participated in an earlier study for sonelokimab. This study is designed as a continuation for those who have already started treatment within the research program.
More specific details about health conditions or other medicines you might be taking would be discussed with the study team to ensure this study is right for you and safe 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.
- Are you 18 years old or older?
- Do you have psoriatic arthritis?
- Have you already taken part in a previous clinical study for sonelokimab?
- Are you able to attend regular clinic visits?
- Are you comfortable knowing both you and your doctor will know you are receiving sonelokimab?
What does participation involve?
If you decide to take part in this study, you will continue to receive sonelokimab. Your participation will involve regular visits to the study clinic, where doctors and nurses will monitor your health closely. These visits will include checks of your vital signs (blood pressure, heart rate), physical examinations, and blood tests to look at your general health and how the medicine is affecting you. You may also have an electrocardiogram (ECG) to check your heart.
The study team will ask you about any new symptoms or side effects you might experience. They will also assess how well the medicine is working for your psoriatic arthritis. The total length of your participation will depend on the study design, but it is an extension study, so it's designed to gather long-term information.
Potential risks and benefits
Locations (16)
- —UnverifiedEstonia
- —UnverifiedCroatia
- —UnverifiedSlovakia
- —UnverifiedLithuania
- —UnverifiedRomania
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedLatvia
- —UnverifiedPoland
- —UnverifiedPortugal
- —UnverifiedGreece
Common questions
What is psoriatic arthritis?
Psoriatic arthritis is a type of arthritis that affects some people with psoriasis. It can cause joint pain, swelling, and stiffness throughout the body.
What is sonelokimab?
Sonelokimab is a new medicine being tested to see if it can help people with psoriatic arthritis. It's not yet available for general use.
Who can join this study?
This study is for adults (18 years or older) who have psoriatic arthritis and have already participated in a previous study testing sonelokimab.
What happens during the study?
You'll continue to receive sonelokimab and have regular check-ups, blood tests, and heart checks (ECGs) to make sure the medicine is safe and working.
What does 'long-term safety' mean?
It means the study will monitor your health for an extended period to see if the medicine causes any side effects or health problems over time when used regularly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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