RecruitingPHASE2INTERVENTIONAL

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)

This research study is looking into a new medicine called tulisokibart (MK-7240) for people living with rheumatoid arthritis (RA). Many people with RA find that their usual treatments, like methotrexate, don't fully control their symptoms. This study aims to find out if tulisokibart can help reduce the symptoms of active RA in those who are already taking methotrexate. Researchers will test different doses of the new medicine to see if any of them work better than a placebo (a dummy medicine with no active ingredients). Comparing the new medicine to a placebo helps researchers understand its effects more clearly. The study will last for about 2.5 years, with an initial 12-week period and a longer follow-up.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

182

Start

08 Oct 2025

Estimated completion

03 Sep 2029

Arthritis, Rheumatoid

What is this study about?

This study is investigating a new medicine called tulisokibart for people with rheumatoid arthritis, often shortened to RA. RA is a long-lasting condition where your immune system, which normally fights off infections, mistakenly attacks the lining of your joints. This can cause pain, swelling, and stiffness, and can sometimes lead to damage.

While medicines like methotrexate are commonly used and can be very helpful, they don't work for everyone, or they might not fully control all symptoms for some people. This means there's a real need to find new and more effective treatments. The main goal of this study is to see if tulisokibart can reduce the pain, swelling, and stiffness associated with active RA better than current treatments alone.

Researchers will be giving some people tulisokibart in different doses, while others will receive a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active ingredients. This is a common way to test new medicines and helps researchers understand if any improvements are truly due to the study medicine or just to other factors. The study will also carefully observe how safe the medicine is.

Key takeaways

This study is testing a new medicine, tulisokibart, for active RA.
It's for people whose RA symptoms aren't fully controlled by methotrexate.
Some participants will get the new medicine, others a dummy medicine (placebo).
The study aims to see if tulisokibart reduces RA symptoms better than placebo.
It involves regular clinic visits for check-ups and blood tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would typically need to be an adult between 18 and 80 years old with a clear diagnosis of rheumatoid arthritis that started after the age of 17. Your RA should still be active, meaning you have at least six tender and six swollen joints, even if you're already taking methotrexate. You might also be considered if you haven't yet tried certain stronger RA medications (called biologic DMARDs) or if those medications haven't worked well for you in the past.

However, there are also some reasons why you might not be able to join. For example, if you have other types of arthritis or inflammatory joint conditions such as psoriatic arthritis or gout, this study wouldn't be suitable for you. You also couldn't take part if you've had certain types of cancer in the last five years, have an active infection, or are allergic to the study medicine or its ingredients.

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 between 18 and 80 years old?
Do you have a diagnosis of rheumatoid arthritis?
Is your RA currently active, with noticeable joint pain and swelling?
Are you currently taking methotrexate for your RA?
Have you had certain types of cancer in the last 5 years? (If yes, you may not be eligible)
Do you have other inflammatory joint conditions like psoriatic arthritis or gout? (If yes, you may not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either receive tulisokibart (in one of the doses being tested) or a placebo, alongside your existing methotrexate. The study starts with a 12-week period where the main comparison between the study medicine and placebo will happen. If you continue after this, there's a longer follow-up period that could last up to about 2.5 years in total. During this time, you'll have regular visits to the clinic for check-ups. These visits will involve physical examinations, blood tests, and discussions about your symptoms and how you're feeling. You'll also need to keep taking your methotrexate as usual. The study team will explain everything in detail, including how often you'll need to visit and what each visit will involve.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from potentially receiving a new medicine that could improve your RA symptoms if your current treatments aren't fully effective. However, it's also possible you could receive the placebo, or that the study medicine might not work for you. As with any medicine, tulisokibart could have side effects, and the study team will monitor you closely for these. You will be given more information about known side effects before you decide to take part. It's very important to remember that joining this study is completely your choice, and you can withdraw at any time without affecting your usual medical care.

Locations (62)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Verified postcode
Glendale, United States· Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Verified postcode
Mesa, United States· Recruiting
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
Verified postcode
La Palma, United States· Recruiting
Tekton Research, LLC. ( Site 1008)
Verified postcode
Fort Collins, United States· Recruiting
Sweet Hope Research Specialty, Inc ( Site 1015)
Verified postcode
Hialeah, United States· Recruiting
HMD Research LLC ( Site 1016)
Verified postcode
Orlando, United States· Recruiting
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
Verified postcode
Orland Park, United States· Recruiting
AA Medical Research Center ( Site 1027)
Verified postcode
Grand Blanc, United States· Recruiting
Kansas City Physician Partners ( Site 1032)
Verified postcode
Kansas City, United States· Recruiting
Physician Research Collaboration, LLC ( Site 1002)
Verified postcode
Lincoln, United States· Recruiting
altoona center for clinical research ( Site 1005)
Verified postcode
Duncansville, United States· Recruiting
Rheumatology Specialty Center ( Site 1030)
Verified postcode
Willow Grove, United States· Recruiting

Common questions

What is rheumatoid arthritis (RA)?

RA is a long-term condition where your immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.

What is a placebo?

A placebo looks like the study medicine but contains no active ingredients. It helps researchers see if the real medicine has an effect.

How long will the study last?

The study has an initial 12-week period where the main comparison takes place, potentially followed by a longer period, up to about 2.5 years in total.

Will I still take my usual RA medicine?

Yes, you will continue to take your methotrexate as part of this study.

What if I change my mind?

You are free to leave the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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