A Phase 2 open-label imaging study to explore the effects of sonelokimab in patients with active axial spondyloarthritis
This research study is investigating a new medication called sonelokimab for individuals living with active axial spondyloarthritis. This condition primarily causes inflammation in the spine and joints between the spine and pelvis. The main goal is to find out if sonelokimab can help reduce inflammation in these areas after 12 weeks, which will be measured using special PET scans that can show changes in joint activity. The study will also look at whether the medicine improves daily symptoms, how active the disease is, and how it affects overall physical abilities and pain. It's a 'Phase 2' study, meaning it's still in the earlier stages of testing to see how well the medicine works and if it's safe.
At a glance
What is this study about?
This study is for people who have a condition called axial spondyloarthritis, which is a type of arthritis that mainly affects the spine and the joints connecting the spine to the pelvis (these are called sacroiliac joints). It causes pain, stiffness, and can sometimes lead to damage in these areas. The study is testing a new medicine called sonelokimab to see if it can help reduce the inflammation that causes these symptoms.
The main thing researchers want to find out is whether sonelokimab can reduce inflammation in your sacroiliac joints and spine. They will measure this using a special type of scan called a PET scan. This scan uses a small amount of a safe substance that helps highlight areas of inflammation. By comparing scans taken at the beginning and after 12 weeks of treatment, they can see if the medicine is having an effect.
Beyond checking inflammation with scans, the study will also look at many other aspects of your health. This includes how your pain, stiffness, and overall disease activity change, using various questionnaires and physical assessments. They will also look at how your daily physical function and quality of life are affected. All these measurements help researchers get a full picture of how sonelokimab might help people with axial spondyloarthritis.
Key takeaways
- This study is testing a new medicine for axial spondyloarthritis.
- It aims to reduce inflammation in the spine and hip joints.
- Special scans will be used to measure inflammation changes.
- The study lasts 12 weeks for participants.
- It's a Phase 2 study, focusing on how well the medicine works and its safety.
Who may be eligible?
To be able to take part in this study, you must be 18 years old or older. The study is open to both men and women.
Further specific requirements about your health condition, medications you might be taking, and other medical history will be discussed with you by the study team. This is to make sure the study is a good and safe fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with active axial spondyloarthritis?
- Are you able to attend regular clinic appointments?
- Are you willing to undergo PET and MRI scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the study medication, sonelokimab. You would also have several appointments for different assessments. These would include special PET scans to measure inflammation in your spine and hip joints, as well as MRI scans for more detailed pictures of these areas. You would also have blood tests, physical examinations by a doctor, and complete questionnaires about your symptoms, pain, and how your condition affects your daily life. The study will run for a period of 12 weeks, during which these assessments will be carried out to track any changes. You would have regular visits to the clinic for these tests and to check on your progress.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is axial spondyloarthritis?
It's a type of arthritis that mainly causes pain and stiffness in the spine and the joints connecting your spine to your pelvis.
What is sonelokimab?
It's a new medicine being tested to see if it can help reduce inflammation caused by axial spondyloarthritis.
What is a PET scan?
It's a special type of scan that helps doctors see areas of inflammation in your body, using a small, safe substance.
How long will the study last for me?
The main treatment and assessment period for participants in this study is 12 weeks.
Will I know if the medicine is working for me?
The study team will discuss your results with you, but they cannot promise that the medicine will definitely help your condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.