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Study on Lutikizumab and Risankizumab for Adults with Active Psoriatic Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The study will explore the effects of two medications: Lutikizumab and Risankizumab. Lutikizumab, also known by its code name ABT-981, and Risankizumab, referred to as ABBV-066, are both given as injections under the skin.

The purpose of the study is to evaluate how well these medications work when used together and separately in treating active psoriatic arthritis. Participants will receive either the combination of both medications, one of the medications alone, or a placebo. The study will monitor the participants over a period to see how their symptoms change and to ensure the treatments are safe and well-tolerated.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The main goal is to see if there is a significant improvement in joint symptoms and overall disease activity. The study will also look at the safety of the treatments to ensure they do not cause any harmful effects. This research aims to find more effective ways to manage psoriatic arthritis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either a combination therapy or a monotherapy. This means you will either receive both lutikizumab and risankizumab or just one of these medications.
The study is designed to evaluate the effectiveness and safety of these treatments for psoriatic arthritis.
Step 2
Treatment administration
You will receive the medication through a subcutaneous injection, which is an injection under the skin. The medication comes in a solution form, either in a pre-filled syringe or a regular syringe.
The frequency and dosage of the injections will be determined by the study protocol and communicated to you by the study team.
Step 3
Monitoring and assessments
Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track the number of tender and swollen joints, as well as any changes in your condition.
The primary goal is to see if there is a 50% improvement in your symptoms by week 16, as measured by the American College of Rheumatology criteria.
Step 4
End of study evaluation
At the end of the study period, which is estimated to conclude by January 2028, a final evaluation will be conducted to assess the overall effectiveness and safety of the treatment.
The study aims to determine the percentage of participants who achieve significant improvement in their condition, including minimal disease activity and reduction in psoriasis severity.

Who can join the trial?

5 criteria

The person must be willing and able to follow the procedures required in the study.
The person must have a documented clinical diagnosis of Psoriatic Arthritis (PsA), with symptoms starting at least 6 months before the screening visit. They must also meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at the screening visit.
The person must have active disease, which means having at least 3 tender joints (out of 68 possible) and at least 3 swollen joints (out of 66 possible) at both the screening visit and the start of the study.
The person must have active plaque Psoriasis (PsO) or a documented history of plaque Psoriasis.
Both males and females can participate in the study.

Who cannot join the trial?

10 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
Patients who have received any live vaccines within the last 4 weeks. Live vaccines contain a small amount of the actual virus or bacteria they are meant to protect against.
Patients who have a history of allergic reactions to similar medications used in the study.
Patients who are currently participating in another clinical trial. A clinical trial is a research study to test new treatments.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who are pregnant or breastfeeding.
Patients who have had a major surgery within the last 12 weeks.
Patients with uncontrolled high blood pressure. This means blood pressure that is not managed well with medication or lifestyle changes.
Patients with active cancer or a history of cancer within the last 5 years, except for certain types of skin cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Regional Universitaire De Tours
Tours, France
Verified
Centre Hospitalier Universitaire De Nice
Nice, France
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

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Investigated drugs

Lutikizumab
is a medication being studied for its potential to help people with active psoriatic arthritis. It works by targeting specific proteins in the body that are involved in inflammation. By reducing inflammation, lutikizumab may help to relieve joint pain and swelling, which are common symptoms of psoriatic arthritis.
Risankizumab
is another medication being tested in this study for treating active psoriatic arthritis. It is designed to block certain proteins in the immune system that can cause inflammation and lead to joint damage. By interfering with these proteins, risankizumab aims to reduce the symptoms of psoriatic arthritis, such as pain and stiffness, and improve the overall quality of life for patients.

What is already known about the treatment

Lutikizumab
Lutikizumab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness in treating psoriatic arthritis. This medication is still under investigation, so it is not yet widely available or fully endorsed in medical literature. It is primarily being explored for its potential to reduce inflammation and alleviate symptoms associated with psoriatic arthritis. Lutikizumab works by targeting specific proteins in the body that contribute to inflammation, helping to calm the immune system's overactive response. It is classified as an anti-inflammatory agent.
Risankizumab
Risankizumab is also administered as an injection under the skin and is being evaluated in clinical trials for its use in treating psoriatic arthritis. Like lutikizumab, it is not yet fully established in medical practice but shows promise in reducing the symptoms of this condition. Risankizumab functions by blocking certain proteins that play a key role in the inflammatory process, thereby reducing the immune system's attack on the joints and skin. It is categorized as a monoclonal antibody used to manage inflammation.

Investigated diseases

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 vary in severity. The disease often begins with mild symptoms and can progress to more severe joint damage over time. It may affect any joint in the body, including the spine, and can lead to reduced range of motion. The progression of psoriatic arthritis can be unpredictable, with periods of increased activity and remission. Skin symptoms, such as red patches covered with silvery scales, often accompany joint symptoms.