RecruitingPHASE3INTERVENTIONAL

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

This research study is looking at a new medicine called sonelokimab. It's for adults in the UK who have psoriatic arthritis, a condition that causes joint pain and skin problems. Participants in this study will have tried other medicines (called TNFα blockers) for their psoriatic arthritis in the past, but these treatments either didn't work well enough or caused side effects. The main goal is to find out if sonelokimab is safe and effective in reducing the symptoms of psoriatic arthritis. We're comparing it to a dummy treatment (placebo) or an already approved medicine called risankizumab. This will help doctors understand if sonelokimab could be a helpful new option for people struggling with this condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

MoonLake Immunotherapeutics AG

Enrolment target

600

Start

15 Oct 2024

Estimated completion

15 Jan 2027

Arthritis, Psoriatic

What is this study about?

You've been invited to learn about a research study for people with psoriatic arthritis. Psoriatic arthritis is a condition where your body's immune system mistakenly attacks healthy joints and skin, causing pain, swelling, and sometimes skin rashes. Doctors are always looking for better ways to manage this condition, especially for those whose current treatments aren't working as well as they should.

This particular study is focusing on a new medicine called sonelokimab. It's designed to calm down the overactive immune system that causes the symptoms of psoriatic arthritis. Some people with psoriatic arthritis have tried a type of medicine called TNFα blockers, but for various reasons, these haven't been suitable or effective enough for everyone. This study wants to see if sonelokimab could be a good alternative option in these cases.

By taking part, you would be helping doctors understand if sonelokimab is safe and if it can effectively reduce the pain and swelling associated with psoriatic arthritis. It's a key step in potentially making this new treatment available to more people in the future.

Key takeaways

This study is testing a new medicine, sonelokimab, for psoriatic arthritis.
It's for adults whose previous treatments (TNFα blockers) didn't work well or caused side effects.
Participants will receive sonelokimab, a placebo (dummy medicine), or an existing approved medicine.
The study aims to check if sonelokimab is safe and effective for treating psoriatic arthritis.
Taking part involves regular clinic visits for assessments and blood tests.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old, and have a confirmed diagnosis of psoriatic arthritis that's been active for at least six months. Your joints should currently show signs of active arthritis, meaning you have a certain number of tender and swollen joints. You also need to have plaque psoriasis, or a history of it confirmed by a skin doctor.

Importantly, you must have tried at least one TNFα blocker medicine for your psoriatic arthritis or psoriasis in the past. This previous treatment either didn't work well enough (even after taking it for at least three months at the right dose) or caused side effects that made you stop taking it.

There are also some reasons why you might not be able to join. For example, if you're allergic to sonelokimab or risankizumab (another medicine being used in the study), or if you have certain other long-term inflammatory conditions like inflammatory bowel disease (Crohn's or ulcerative colitis). Also, if you've previously taken sonelokimab or certain other types of immune-modifying medications for your psoriatic arthritis or psoriasis (other than TNFα blockers), you wouldn't be able to participate.

Quick self-check

Are you 18 years old or older?
Do you have a firm diagnosis of psoriatic arthritis that's been active for at least 6 months?
Do you currently have active joint pain and swelling?
Do you have plaque psoriasis or a past history of it?
Have you previously tried at least one TNFα blocker medicine for your psoriatic arthritis or psoriasis that didn't work well or caused bad side effects?
Are you NOT allergic to sonelokimab or risankizumab OR do you NOT have inflammatory bowel disease?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of four groups. Three groups will receive different doses of sonelokimab, while one group will receive a 'placebo' (a dummy treatment that looks like the study medicine but contains no active drug). You won't know which treatment you're receiving, nor will the study staff who are looking after you.

Your participation will involve regular visits to the study clinic over a certain period. At these visits, you'll have various assessments to check your psoriatic arthritis symptoms, general health, and any side effects. This will likely include physical examinations, blood tests, and questionnaires about your pain and quality of life. The study will last for a specific duration, which the study team will explain to you in detail, along with the schedule of visits and what each visit entails. There will be follow-up appointments even after you stop taking the study medicine.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medicine that isn't widely available yet, which could help improve your psoriatic arthritis symptoms. However, like all medicines, sonelokimab may have side effects, some of which are not yet fully known. There's also a chance you might receive the placebo and not the active study medicine. The study team will explain all known potential risks and side effects to you. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (136)

Clinical Site
Avondale, United States· Recruiting
Clinical Site
Chandler, United States· Completed
Clinical Site
Flagstaff, United States· Completed
Clinical Site
Mesa, United States· Recruiting
Clinical Site
Phoenix, United States· Recruiting
Clinical Site
Scottsdale, United States· Recruiting
Clinical Site
Tucson, United States· Recruiting
Clinical Site
Jonesboro, United States· Recruiting
Clinical Site
La Jolla, United States· Recruiting
Clinical Site
Pomona, United States· Recruiting
Clinical Site
San Diego, United States· Recruiting
Clinical Site
Santa Monica, United States· Recruiting

+124 more sites — see the official record for the full list.

Common questions

What is psoriatic arthritis?

It's a type of arthritis that affects some people with psoriasis. It causes joint pain, stiffness, and swelling, and can also affect the skin and nails.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly effective.

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

No, neither you nor the study doctors will know which treatment you are receiving until after the study is over. This is called 'double-blind' and helps ensure fair results.

What does 'inadequate response' mean?

It means a previous medicine you tried for your psoriatic arthritis didn't work well enough to control your symptoms, or you had problems with side effects that made you stop taking it.

How long will the study last?

The full duration of your participation, including all visits and follow-ups, will be explained in detail by the study team before you decide to join.

How to find out more

Moonlake Clinical Trial Helpdesk

ClinicalTrials@moonlaketx.com +41 41 510 8022 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.