RecruitingPHASE2INTERVENTIONAL

A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)

This research study aims to find out if a new medicine called tulisokibart can help people with radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and swelling in your back and the joints connecting your spine to your hips. The term 'radiographic' means that changes caused by the condition can be seen on X-rays. The study will involve testing different amounts (doses) of tulisokibart. Researchers will compare how well tulisokibart works against a 'placebo' – a dummy medicine that looks the same but contains no active drug. This comparison helps scientists understand the true effects of the study medicine. The goal is to see if any dose of tulisokibart can improve r-axSpA symptoms better than the placebo.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

315

Start

26 Sep 2025

Estimated completion

05 Feb 2030

Radiographic Axial Spondyloarthritis

What is this study about?

This study is about exploring a new treatment option for a long-term condition called radiographic axial spondyloarthritis, often shortened to r-axSpA. This is a form of arthritis that mainly affects your spine and the joints in your pelvis (the large bones at the bottom of your spine). If you have r-axSpA, you might experience ongoing back pain, stiffness, and inflammation, which is when parts of your body become warm, red, and swollen. The 'radiographic' part means that doctors can see signs of damage or changes in your bones using X-rays.

The main purpose of this study is to see if an experimental medicine, called tulisokibart, can help reduce these symptoms and improve how people with r-axSpA feel. The researchers will be looking at different doses of this medicine to work out which might be most effective. They want to find out if tulisokibart can make a difference compared to a placebo, which is a tablet or injection that looks exactly like the study medicine but doesn’t contain any active drug. Comparing against a placebo is a standard way to ensure that any improvements seen are due to the medicine itself and not just other factors.

Taking part in a study like this helps advance medical understanding and could potentially lead to new treatments becoming available for people living with r-axSpA in the future. It’s an important step in the journey of developing new medicines.

Key takeaways

This study is testing a new medicine called tulisokibart for radiographic axial spondyloarthritis (r-axSpA).
It aims to see if the medicine can reduce pain, stiffness, and swelling better than a placebo.
The study lasts for over two years, with regular clinic visits and tests.
Participants will receive either the study medicine or a placebo initially, then switch to the active medicine.
You'll get close medical monitoring throughout your participation.

Who may be eligible?

To join this study, you would generally need to be an adult between 18 and 80 years old and have a confirmed diagnosis of radiographic axial spondyloarthritis (r-axSpA). This means that not only do you have the usual back pain and stiffness associated with the condition, but also that X-rays show specific changes in your spine or pelvis.

Additionally, your current r-axSpA symptoms need to be considered 'active,' meaning they are bothering you significantly. The study is particularly interested in people who haven't responded well to common medications like NSAIDs (non-steroidal anti-inflammatory drugs) or have tried up to two other types of arthritis medicines called bDMARDs without success, or who haven't yet tried bDMARDs at all.

However, there are also reasons why you might not be able to join. For example, if you have other types of inflammatory arthritis, a history of certain cancers within the last five years, or any active infections, this study might not be suitable for you. Also, if you know you are allergic to the study medicine, tulisokibart, or any of its ingredients, you couldn't take part. The research team will carefully review your medical history to make sure it's safe and appropriate for you to participate.

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 radiographic axial spondyloarthritis (r-axSpA), confirmed by X-rays?
Are your r-axSpA symptoms currently active?
Have you had problems with previous treatments like NSAIDs, or tried up to two other specific arthritis medicines (bDMARDs) without enough improvement, or not yet tried bDMARDs?
Do you have any other types of inflammatory arthritis or active infections?
Have you had cancer in the last 5 years (except certain skin cancers that were fully treated)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to check if you are suitable. Once confirmed, you would participate for a total of 140 weeks, which is about 2 years and 8 months. During this time, you will receive either the study medicine, tulisokibart, or a placebo to begin with, for the first 16 weeks.

After these initial 16 weeks, all participants will have the opportunity to continue in a longer part of the study for an additional 124 weeks, where they will receive the active study medicine. This longer period is split into a main extension of 40 weeks and an optional extension of 84 weeks.

Throughout the study, you will have regular visits to the clinic for assessments. These will likely include physical examinations, blood tests, X-rays, and questionnaires to track your symptoms and how you're feeling. The study team will provide all the necessary medication, and you will be closely monitored for any changes in your health.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new investigational treatment that might help your symptoms if other medications haven't worked well. You will also receive careful medical monitoring throughout the study. However, there are also risks; the study medicine may cause side effects, some of which could be serious, and the treatment might not be effective for you. There's also a chance you could receive the placebo and not the active drug during the first part of the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (100)

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

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Verified postcode
Chandler, United States· Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
Verified postcode
Flagstaff, United States· Recruiting
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
Verified postcode
Gilbert, United States· Recruiting
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
Verified postcode
Glendale, United States· Recruiting
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
Verified postcode
Tucson, United States· Recruiting
TriWest Research Associates - Chula Vista ( Site 0013)
Verified postcode
Chula Vista, United States· Recruiting
Providence Medical Foundation ( Site 0049)
Verified postcode
Fullerton, United States· Recruiting
Newport Huntington Medical Group ( Site 0005)
Verified postcode
Huntington Beach, United States· Recruiting
Cohen Medical Centers ( Site 0034)
Verified postcode
Thousand Oaks, United States· Recruiting
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
Verified postcode
Upland, United States· Recruiting
Arthritis and Rheumatic Disease Specialties ( Site 0016)
Verified postcode
Aventura, United States· Recruiting
Bay Area Arthritis and Osteoporosis ( Site 0041)
Verified postcode
Brandon, United States· Recruiting

Common questions

What is r-axSpA?

Radiographic axial spondyloarthritis (r-axSpA) is a type of arthritis that causes pain, stiffness, and swelling in the spine and hip joints. 'Radiographic' means changes can be seen on X-rays.

What is tulisokibart?

Tulisokibart is an experimental medicine being tested in this study to see if it can help treat the symptoms of r-axSpA.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study medicine but contains no active drug. It helps researchers understand if the real medicine is truly effective.

How long will the study last?

The study involves an initial 16-week period, followed by a longer extension phase, meaning you could be involved for up to 140 weeks (about 2 years and 8 months) in total.

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

During the first 16 weeks, you will not know if you're receiving tulisokibart or the placebo. After this initial period, all participants will receive the active study medicine.

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.