Study of Ixekizumab Treatment Effects on Joint and Bone Inflammation in Patients with Axial Spondyloarthritis and Psoriatic Arthritis Using Advanced Imaging Methods

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What is this study about?

This study focuses on two conditions: Axial Spondyloarthritis (a type of arthritis mainly affecting the spine and sacroiliac joints) and Psoriatic Arthritis (a form of arthritis that affects some people who have psoriasis). The study will investigate a medication called ixekizumab, which is given as an injection under the skin.

The purpose of this research is to examine how ixekizumab affects inflammation throughout the entire body, including joints and areas where tendons and ligaments attach to bones. The medication will be administered as a solution for injection, with participants receiving up to 160 mg per day. The study will use special imaging techniques including MRI (magnetic resonance imaging) and CT (computed tomography) scans to monitor the effects of treatment.

The study will last for two years, during which participants will receive regular medical evaluations and imaging scans. The research will help understand how effectively the medication reduces inflammation in different parts of the body in people with these conditions. Throughout the study, doctors will monitor how the treatment affects both the spine and other joints in the body.

1 Initial treatment start

You will receive Taltz (ixekizumab) as a solution for injection under the skin (subcutaneous injection)

The medication will be administered through a pre-filled syringe containing 80 mg of the active substance

2 Treatment monitoring – Year 1

Your entire body will be examined using whole-body MRI (a special type of imaging that shows detailed pictures of your joints and surrounding tissues)

The medical team will track changes in inflammation in your joints and attachment points where tendons connect to bones

Regular assessments will monitor your response to the treatment

3 Treatment monitoring – Year 2

The treatment and monitoring will continue for a second year

Additional imaging tests will be performed using MRI-based synthetic CT and regular CT scans

These tests will provide detailed information about how your joints and bones are responding to the treatment

4 Final assessment

At the end of the study period, a final evaluation will compare your current condition with your initial state

The assessment will focus on changes in inflammation throughout your body

The study will track improvements in both spine-related symptoms and joint inflammation

Who Can Join the Study?

Must be 18 years of age or older at the time of giving consent
Must have a doctor’s recommendation for treatment with biological drugs (medications derived from living organisms)
Women must use adequate contraception methods
Must be willing and able to provide written informed consent and follow study requirements
For patients with axial spondyloarthritis (axSpA):
- Must meet ASAS classification criteria for axSpA (a specific set of symptoms and signs of the condition)
- Must have active inflammation visible on MRI of joints where spine meets pelvis, or spine changes visible on X-ray
- Must have back pain rated at least 40 out of 100 on a pain scale
For patients with psoriatic arthritis (PsA):
- Must meet CASPAR criteria for PsA (specific diagnostic criteria for the condition)
- Must have negative blood tests for rheumatoid factor and anti-CCP
- Must have at least one tender and swollen joint plus two other areas showing inflammation
- If spine is affected, must have evidence on imaging (MRI, X-ray, or CT scan)

Who Cannot Join the Study?

History of severe allergic or anaphylactic reactions to biological medications (medications derived from living organisms)
Active or untreated tuberculosis infection
Presence of serious infections requiring hospitalization or treatment with intravenous antibiotics in the past 3 months
Any active or unstable autoimmune disease (where the immune system attacks healthy cells) other than psoriatic arthritis or axial spondyloarthritis
History of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
Significant heart, liver, or kidney disease that is not well controlled
Presence of demyelinating conditions (diseases affecting the protective covering of nerves) such as multiple sclerosis
Pregnant or breastfeeding women
Unable to undergo MRI scanning (due to metal implants, claustrophobia, or other contraindications)
Current participation in other clinical trials or use of any investigational drugs within 30 days before starting this study
History of alcohol or drug abuse within the past year
Any condition that, in the investigator’s opinion, would make participation unsafe or could interfere with the study evaluations

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Frederiksberg Hospital	Frederiksberg	Denmark
Slagelse Hospital	Slagelse	Denmark
Rigshospitalet	Copenhagen	Denmark
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.04.2024

Trial locations

Ixekizumab (IXE) is a medication used to treat inflammatory conditions such as axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). It works by targeting and blocking a specific protein in the body that causes inflammation. This medication helps reduce inflammation throughout the body, particularly in joints and areas where tendons and ligaments attach to bones (entheses). It is administered as an injection under the skin and helps improve symptoms such as joint pain, stiffness, and swelling in patients with these conditions.

Investigated diseases:

Axial spondyloarthritis

Psoriatic Arthritis – A chronic inflammatory joint condition that typically occurs in people with psoriasis. It causes joint pain, stiffness, and swelling that can affect any part of the body, particularly the fingers, toes, and spine. The condition often appears as swelling and inflammation in and around the joints, along with skin patches characteristic of psoriasis. The disease can vary in severity and may affect one or multiple joints. Over time, it can lead to changes in joint appearance and reduced range of motion.

Axial Spondyloarthritis – A chronic inflammatory arthritis that primarily affects the spine and sacroiliac joints where the spine connects to the pelvis. The condition typically begins with gradual back pain and stiffness, especially in the morning or after periods of inactivity. It commonly starts in early adulthood and develops slowly over time. The inflammation can cause some of the vertebrae to fuse together, reducing flexibility in the spine. The condition may also affect other joints and can cause fatigue.

Trial ID:

2024-510746-14-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Ixekizumab Treatment Effects on Joint and Bone Inflammation in Patients with Axial Spondyloarthritis and Psoriatic Arthritis Using Advanced Imaging Methods

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?