Study on the Effects of Risankizumab in Patients with Very Early Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for axial spondyloarthritis, a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. The treatment being tested is called Skyrizi, which contains the active substance risankizumab. This medication is administered as a solution for injection using a pre-filled pen. The purpose of the study is to investigate how this treatment affects the activity of the disease in patients who have very early signs of active axial spondyloarthritis.

Participants in the study will receive the treatment over a period of 28 weeks. During this time, the effects of the medication on their disease activity will be closely monitored. The study will also include a comparison with a placebo to better understand the treatment’s effectiveness. After the treatment period, participants will be observed for an additional period to see if the benefits of the treatment continue even after it is stopped. The study aims to determine if the treatment can lead to a significant reduction in disease activity and improve the overall health and function of the participants.

Throughout the study, various assessments will be conducted, including MRI scans to evaluate changes in inflammation and other symptoms. The study will also measure improvements in the participants’ ability to perform daily activities and their overall quality of life. The results will help determine if Skyrizi can provide a meaningful improvement in managing very early axial spondyloarthritis and potentially modify the course of the disease.

1 initial treatment phase

The treatment involves the use of Skyrizi, which contains the active substance risankizumab. This medication is administered as a subcutaneous injection.

The dosage is 150 mg of Skyrizi, given as a solution for injection in a pre-filled pen.

The treatment is designed to investigate its effects on disease activity in patients with very early active axial spondyloarthritis (axSpA).

2 treatment duration

The treatment phase lasts for 28 weeks.

During this period, the effects of the medication on disease activity will be closely monitored.

3 primary assessment

The primary endpoint is assessed 4 weeks after the last injection, which is at week 32 of the study.

The main goal is to determine the proportion of patients in low disease activity, defined as an ASDAS status of less than 2.1.

4 secondary assessments

Secondary endpoints include the improvement of the patient’s global assessment and the proportion of patients in inactive disease, defined as an ASDAS status of less than 1.3 at week 32 and week 56.

Other assessments include improvement in MRI-related inflammatory lesions, proportion of patients with good overall clinical function, and a major clinical response defined as a 50% improvement of the initial BASDAI score.

Changes from baseline in BASMI and BASFI are also evaluated after 28 weeks of treatment, assessed 4 weeks after the last injection.

5 follow-up phase

The follow-up phase includes monitoring the proportion of patients who maintain low disease activity for at least 6 months after treatment withdrawal.

This phase helps to understand the long-term effects of the treatment on disease activity.

Who Can Join the Study?

The patient must sign a written informed consent form that has been approved by an ethics committee.
The patient must have a baseline MRI available and agree to the planned MRI procedures. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
The patient must be considered reliable and able to follow the study rules, attend scheduled visits, and take medications as instructed by the study doctor.
The patient must be at least 18 years old and not older than 40 years at the time of the screening visit.
The patient must have a documented diagnosis of very early axial spondyloarthritis (axSpA) with symptoms lasting at least 3 months but less than 2 years.
The patient must have active disease at the screening and baseline visit, defined by a BASDAI score of 4 or higher out of 10 and spinal pain of 4 or higher out of 10 on a numerical rating scale (NRS). BASDAI is a tool used to measure disease activity in patients with axSpA. The patient must also have either an elevated CRP level or current evidence of sacroiliitis on an MRI scan within 3 months prior to baseline. CRP is a blood test that measures inflammation, and sacroiliitis is inflammation of the joints in the lower back.
The patient must be HLA-B27 positive at screening. HLA-B27 is a genetic marker that can be associated with certain types of arthritis.
The patient must have shown intolerance or inadequate response to at least 2 NSAIDs. NSAIDs are medications used to reduce pain and inflammation. An inadequate response means the patient did not improve after taking the highest tolerated dose of an NSAID for at least 14 days continuously.
The patient must not have received pre-treatment with b- and ts-DMARDs before screening. This means the patient should not have been treated with certain types of medications used to treat arthritis.
Female patients who can become pregnant must use an effective method of birth control during the study and for at least 5 months after the last dose of study treatment. Male patients who are not sterile must ensure that they or their partner use adequate contraception for the duration of the study.

Who Cannot Join the Study?

Patients who have other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain vaccines recently.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have certain blood disorders.
Patients who have a weakened immune system.

Where you can join this trial?

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Other Sites

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

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

Risankizumab

Risankizumab is a medication being studied for its effects on patients with very early axial spondyloarthritis, a type of inflammatory arthritis that affects the spine and the joints connecting the spine to the pelvis. This medication works by inhibiting a specific protein in the body called IL-23, which plays a role in the inflammation process. The goal of using risankizumab in this trial is to see if it can reduce disease activity and potentially modify the course of the disease.

Investigated diseases:

Axial spondyloarthritis

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, often beginning in early adulthood. The disease can lead to reduced flexibility and mobility in the spine over time. Symptoms may fluctuate, with periods of increased activity and remission. In some cases, it can also affect other joints and organs, such as the eyes and skin. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe limitations.

Trial ID:

2023-507718-28-00

Protocol code:

EXPLAIN

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Risankizumab in Patients with Very Early Axial Spondyloarthritis

What is this study about?

Who Can Join the Study?

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