Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

This research study is testing a new medicine called sonelokimab for adults who have active psoriatic arthritis. This is a type of arthritis linked to the skin condition psoriasis. The study wants to find out if sonelokimab is effective at reducing symptoms and is safe to use compared to a dummy treatment (placebo). Participants in this study will not have used certain strong arthritis medications (called biologic DMARDs) before. By comparing sonelokimab to a placebo, researchers can see how well it works and if it has side effects. The aim is to help people with psoriatic arthritis feel better and improve their quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

MoonLake Immunotherapeutics AG

Enrolment target

960

Start

15 Oct 2024

Estimated completion

04 Feb 2027

Arthritis, Psoriatic

What is this study about?

This study is looking into a new medication called sonelokimab for people living with psoriatic arthritis. Psoriatic arthritis is a long-term condition that causes joint pain, stiffness, and swelling, and often occurs in people who also have psoriasis, a skin condition. The main goal of this research is to see how well sonelokimab works and if it's safe for adults who have active psoriatic arthritis but haven't yet tried a specific type of strong medicine known as a 'biologic disease-modifying antirheumatic drug' (or bDMARD).

To figure this out, some participants will receive sonelokimab, while others will receive a placebo, which looks like the real medicine but contains no active drug. This is done to fairly compare the new medicine's effects. The study is "double-blind," meaning neither the participants nor the doctors will know who is getting the real medicine and who is getting the placebo. This helps ensure the results are unbiased and reliable.

This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use. By carefully studying sonelokimab, researchers hope to offer a new treatment option that could help people manage their psoriatic arthritis symptoms more effectively and potentially improve their daily lives.

Key takeaways

This study tests a new medicine, sonelokimab, for psoriatic arthritis.
It's for adults with active psoriatic arthritis who haven't used powerful `biologic` drugs before.
The study compares sonelokimab to a dummy treatment (placebo) to check effectiveness and safety.
You'll have regular medical checks and injections under the skin.
You won't know if you're getting the active drug or the placebo.
Participants can leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have an official diagnosis of psoriatic arthritis for at least six months. Your arthritis must be currently active, meaning you have at least three tender and three swollen joints. You also need to have active psoriasis on your skin or a confirmed history of having it.

There are also some important things that would mean you can't join. For example, if you're allergic to any part of the sonelokimab medicine, or if you have other ongoing inflammatory conditions apart from psoriasis or psoriatic arthritis. This includes conditions like inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).

People who have previously taken sonelokimab or any other biologic immune-modifying drugs for psoriatic arthritis or psoriasis cannot participate. Also, if you have a severe form of arthritis called 'arthritis mutilans,' or have had unexplained diarrhea for three weeks or more recently, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of psoriatic arthritis with active joint problems?
Do you currently have psoriasis or a history of it?
Have you never taken a 'biologic' medication for your arthritis or psoriasis?
Do you have any other inflammatory conditions besides psoriasis or psoriatic arthritis (like inflammatory bowel disease)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either sonelokimab or a placebo (a dummy medicine) through injections under your skin. You won't know which one you're getting, and neither will your study doctor, to keep the results fair. You will have regular visits to the study clinic where doctors and nurses will monitor your health, check your joints, and assess your skin to see how the treatment is affecting your psoriatic arthritis. You'll also likely have blood tests and other examinations.

The study involves several visits over a period of time, with some initial intense monitoring, followed by less frequent check-ups. The full duration of your participation will be explained in detail by the study team, but typically, these studies can last for many months to ensure a thorough evaluation of the new medication. Throughout the study, your medical team will be there to support you and answer any questions.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a new treatment that might improve your psoriatic arthritis symptoms. You will also receive careful medical attention and monitoring throughout the study. However, there are also potential risks, including side effects from the new medicine, which will be fully explained to you. It's important to remember that you might receive the placebo and not the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (169)

Clinical Site
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Avondale, United States
Clinical Site
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Chandler, United States
Clinical Site
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Flagstaff, United States
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Mesa, United States
Clinical Site
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Phoenix, United States
Clinical Site
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Scottsdale, United States
Clinical Site
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Tucson, United States
Clinical Site
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San Diego, United States
Clinical Site
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Upland, United States
Clinical Site
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Avon Park, United States
Clinical Site
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Clearwater, United States
Clinical Site
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Hialeah, United States

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a skin condition. It causes joint pain, stiffness, and swelling.

What is sonelokimab?

Sonelokimab is a new medicine being tested in this study to see if it can help improve symptoms of psoriatic arthritis.

What does 'placebo' mean?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare how well the real medicine works.

Why haven't I heard of sonelokimab before?

Sonelokimab is an investigational drug, meaning it's still being studied and is not yet approved or available for general use outside of clinical trials.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know whether you are receiving sonelokimab or the placebo until the study is over.