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Study on the Effects of Sonelokimab for Patients with Active Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Sonelokimab in patients with a condition known as axial spondyloarthritis. Axial spondyloarthritis is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing inflammation and pain. The purpose of the study is to explore how Sonelokimab, administered as an injection, can help reduce inflammation in these areas.

Participants in the study will receive Sonelokimab through a subcutaneous injection, which means it is injected under the skin. The study will monitor changes in inflammation using a special imaging technique called a positron emission tomography (PET) scan. This scan helps visualize the activity of the disease in the spine and sacroiliac joints, which are located in the lower back. The study will last for a period of 12 weeks, during which participants will undergo regular assessments to track any changes in their condition.

The trial aims to gather information on how well Sonelokimab works in reducing the symptoms of axial spondyloarthritis and to observe any potential side effects. By the end of the study, researchers hope to better understand the effectiveness of this treatment in managing the disease and improving the quality of life for those affected by it.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures. The participant must provide informed consent, confirming understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of axial spondyloarthritis and ensuring the participant meets the study’s inclusion criteria.

3 baseline measurements

Baseline measurements will be taken, including imaging tests such as a PET scan to measure inflammatory activity. These measurements will serve as a reference for evaluating changes during the study.

4 treatment administration

The participant will receive sonelokimab through a subcutaneous injection. The dosage and frequency will be determined by the study protocol and administered by healthcare professionals.

5 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor the participant’s response to the treatment. This includes repeated imaging tests and evaluations of disease activity.

6 final evaluation

At the end of the study period, a final evaluation will be performed. This includes a comprehensive assessment of changes in inflammatory activity and overall health status.

7 study completion

Upon completion of the study, the participant will be informed of the results and any further steps, if necessary. The participant’s involvement in the study will officially conclude.

Who Can Join the Study?

  • Participants must be at least 18 years old when they sign the consent form.
  • Participants should be reliable and able to follow the study rules, attend visits, and take medication as required. They must also be able to sign the consent form, which means they understand and agree to the study’s requirements and restrictions.
  • Participants must have a diagnosis of axial spondyloarthritis (axSpA), which is a type of arthritis affecting the spine. They should have had back pain for at least 3 months, with symptoms starting before the age of 45. They must show signs of the disease on an MRI (a type of scan) or have a positive CRP (a blood test for inflammation) but no X-ray evidence of a specific joint issue called sacroiliitis. Alternatively, they can have a diagnosis of r-axSpA with X-ray evidence of joint damage.
  • Participants must show signs of active disease, with a BASDAI score of 4 or higher, even after taking full doses of at least two NSAIDs (medications for pain and inflammation) for at least 4 weeks before the study.
  • Participants must have signs of active disease on an MRI of the sacroiliac joints or spine, taken within 4 weeks before the study.
  • Participants must have signs of active disease as shown by a positive NaF-PET scan, which is a special type of imaging test.
  • Participants should ideally not have used certain medications called bDMARDs or tsDMARDs before, but they may have used up to two TNFi medications, one IL-12/23p40 or IL-23p19 inhibitor, or one JAKi.
  • X-rays of the sacroiliac joints must be available from the past 12 months to check for changes and confirm the diagnosis according to specific criteria.
  • Female participants must not be pregnant or breastfeeding. They should either be unable to have children or agree to use highly effective birth control methods during the study and for at least 8 weeks after the last dose of the study treatment. They must have a negative pregnancy test before starting the study.
  • Male participants must agree to use a condom when sexually active with a female partner who can have children during the study and for at least 8 weeks after the last dose of the study treatment, unless they are surgically sterile.

Who Cannot Join the Study?

  • Patients who are not diagnosed with axial spondyloarthritis cannot participate. Axial spondyloarthritis is a type of arthritis that mainly affects the spine and the joints connecting the spine to the pelvis.
  • Patients who are outside the specified age range cannot participate. The age range for this study is typically defined in the trial details.
  • Patients who are not part of the specified clinical trial group cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special considerations.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
03.12.2024

Trial locations

Investigated drugs:

Sonelokimab is a medication being studied for its effects on patients with active axial spondyloarthritis. This trial aims to explore how well sonelokimab can reduce inflammation in the body. The effectiveness of the medication is measured by using a special imaging technique called a PET scan, which helps to see how much inflammation is present.

Investigated diseases:

Axial Spondyloarthritis – Axial spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the sacroiliac joints, which connect the spine to the pelvis. It is characterized by chronic back pain and stiffness, often beginning in early adulthood. The disease can lead to inflammation in other parts of the body, such as the eyes and skin. Over time, the inflammation can cause the bones in the spine to fuse, leading to reduced flexibility and mobility. Symptoms may vary in intensity and can include fatigue and discomfort in the buttocks or lower back. The progression of the disease can be slow, with periods of remission and flare-ups.

Trial ID:
2024-513498-36-00
Protocol code:
M1095-axSpA-202
Trial Phase:
Therapeutic exploratory (Phase II)

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