Study on the Effects of Sonelokimab in Patients with Active Psoriatic Arthritis or Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Sonelokimab in patients with active Psoriatic Arthritis or Axial Spondyloarthritis. These are conditions that cause inflammation in the joints and spine, leading to pain and stiffness. The study aims to explore how this treatment affects the activity of these diseases.

Participants in the study will receive Sonelokimab through a subcutaneous injection, which means it is injected under the skin. Additionally, a special imaging agent called 68Ga-FAPI-46 will be used to help visualize the inflammation in the body. This agent is injected and then detected using a scan called FAPI-PET/CT, which combines positron emission tomography and low-dose computed tomography to create detailed images of the body’s internal structures.

The purpose of the study is to assess changes in disease activity over a period of 12 weeks. Participants will undergo regular imaging scans to monitor the effects of the treatment. The study will help researchers understand how Sonelokimab impacts inflammation in the joints and spine, potentially leading to better treatment options for people with these conditions.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will explain the study procedures and answer any questions you may have.

You will undergo a series of tests to confirm your eligibility for the study. These tests may include blood tests, imaging scans, and a physical examination.

2 medication administration

If eligible, you will begin receiving the study medication, sonelokimab, through a subcutaneous injection. This means the medication will be injected under your skin.

The dosage and frequency of the injections will be determined by the study protocol and communicated to you by the healthcare team.

3 imaging study

Throughout the study, you will undergo imaging studies to assess the effects of the medication. This includes a FAPI-PET/CT scan, which helps visualize inflammation in your body.

These scans will be scheduled at specific intervals, such as at the beginning and at Week 12 of the study.

4 regular follow-up visits

You will have regular follow-up visits with the healthcare team. These visits are important to monitor your health and any changes in your condition.

During these visits, you may be asked to complete questionnaires about your symptoms and overall well-being.

5 end of study visit

At the end of the study period, you will have a final visit. This visit will include a comprehensive assessment of your health and a review of your experience during the study.

The healthcare team will discuss the next steps and any follow-up care that may be needed.

Who Can Join the Study?

Participants must be at least 18 years old.
For Psoriatic Arthritis (PsA) only: Must test negative for rheumatoid factor and anti-cyclic citrullinated peptide antibodies.
For PsA only: Must have active PsA and meet one of the following:
- Did not respond well to at least one non-biologic conventional DMARD (a type of medication) after 12 weeks.
- Cannot tolerate DMARDs.
- Cannot take DMARDs due to other health reasons.
For Axial Spondyloarthritis (axSpA) only: Must have a diagnosis of non-radiographic axSpA with:
- Symptoms starting before age 45.
- Inflammatory back pain for at least 3 months.
- Signs of disease activity on MRI or positive C-Reactive protein test.
For axSpA only: Must show active disease with a BASDAI score of 4 or higher, despite treatment with NSAIDs (a type of pain reliever) for at least 4 weeks.
For axSpA only: Must have signs of active disease on MRI within 4 weeks before screening.
For axSpA only: Ideally, participants should not have used biologic DMARDs or targeted synthetic DMARDs, or have used limited amounts of specific medications with appropriate wash-out periods.
Must have a positive FAPI-PET/CT scan, indicating high inflammatory disease activity.
Female participants must not be pregnant or breastfeeding and must agree to use effective birth control methods during the study and for 8 weeks after the last treatment.
Male participants must agree to use a condom during sexual activity with a female partner who can become pregnant, during the study and for 12 weeks after the last treatment, unless surgically sterile.
Participants must be reliable and able to follow the study protocol and schedule, and must provide signed informed consent.
For PsA only: Must have a confirmed diagnosis of PsA with symptoms for at least 3 months before screening.
For PsA only: Must show evidence of active disease, such as joint swelling or pain.
For PsA only: Must have signs of inflammation, such as enthesitis, tendinitis, synovitis, or dactylitis, confirmed by clinical investigation or imaging tests within 4 weeks before screening.
For PsA only: Must have current active psoriasis, nail changes due to psoriasis, or a history of psoriasis.

Who Cannot Join the Study?

Patients who are not diagnosed with psoriatic arthritis or axial spondyloarthritis cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not willing to undergo the required imaging tests, such as FAPI-PET/CT scans, cannot participate. PET/CT scans are imaging tests that help doctors see how your tissues and organs are functioning.
Patients who are not able to comply with the study procedures and visits cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Erlangen AöR	Erlangen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	28.03.2025

Trial locations

Investigated drugs:

Sonelokimab is a medication being studied for its potential to help people with certain types of arthritis, specifically psoriatic arthritis and axial spondyloarthritis. These are conditions where the immune system mistakenly attacks the joints, causing pain and swelling. Sonelokimab works by targeting specific proteins in the body that are involved in the inflammation process. By blocking these proteins, the medication aims to reduce inflammation and improve symptoms in patients. In this trial, researchers are using special imaging techniques to see how well sonelokimab can reduce disease activity in the body.

Investigated diseases:

Axial spondyloarthritis

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can lead to joint damage over time. The disease often begins with mild symptoms and can progress to more severe joint involvement. It may affect any joint in the body, but commonly involves the fingers, toes, and spine. The progression can vary greatly among individuals, with periods of increased activity and remission. Over time, it can lead to reduced joint function and mobility.

Axial Spondyloarthritis – Axial spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by chronic back pain and stiffness, which can worsen over time. The disease often begins in early adulthood and can lead to reduced flexibility and mobility of the spine. As the condition progresses, it may cause the vertebrae to fuse, leading to a loss of spinal mobility. The progression of symptoms can vary, with some individuals experiencing mild symptoms and others developing more severe spinal changes. The disease can also affect other areas of the body, including the eyes and the gastrointestinal tract.

Trial ID:

2024-514504-13-00

Protocol code:

M1095-snSpA-202

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Sonelokimab in Patients with Active Psoriatic Arthritis or Axial Spondyloarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?