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A study testing tulisokibart for people with rheumatoid arthritis who have not responded well enough to previous treatments

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What is this trial about?

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

This study involves people with Rheumatoid Arthritis, which is a long-term condition where the body's immune system mistakenly attacks the joints, causing pain, swelling, and stiffness. The study will test a medication called tulisokibart, which is also known by its code name MK-7240. Some participants will receive tulisokibart while others will receive placebo. All participants will continue taking their current methotrexate treatment during the study. The purpose of the study is to find out how well tulisokibart works compared to placebo in improving the signs and symptoms of rheumatoid arthritis after 12 weeks of treatment.

The medication tulisokibart will be given as an injection under the skin using a pre-filled device that automatically delivers the medicine. The study will last for about 128 weeks in total. During this time, doctors will check how well the treatment is working by looking at improvements in joint pain, swelling, and other symptoms of the disease. They will also monitor participants for any unwanted effects that may occur during treatment.

The study will measure whether participants achieve certain levels of improvement in their condition, including 20%, 50%, or 70% improvement according to standard measures used for rheumatoid arthritis. Doctors will also assess whether participants reach a state of low disease activity and whether their ability to perform daily activities improves. Throughout the study, any side effects or problems that participants experience will be carefully recorded and reviewed.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting the treatment phase

    Upon joining the study, you will be randomly assigned to receive either tulisokibart or placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

    The medication will be administered as a subcutaneous injection, which means it will be injected under the skin using a pre-filled injector device.

    You will continue taking your current methotrexate medication throughout the study. Methotrexate is a medication commonly used to treat rheumatoid arthritis. Your dose should remain stable at the level you were taking before joining the study.

  2. Step 2

    Regular study visits and assessments

    You will attend scheduled visits where your condition will be assessed and the study medication will be administered.

    During these visits, your joints will be examined, and you will be asked questions about your symptoms and how you are feeling.

    Blood samples may be taken to measure inflammation levels and monitor your safety.

  3. Step 3

    Week 12 assessment

    At Week 12, a comprehensive assessment of your rheumatoid arthritis will be performed.

    The assessment will measure improvement in your condition using standardized criteria called ACR20, ACR50, and ACR70. These criteria evaluate the number of tender and swollen joints, pain levels, and overall disease activity.

    Your disease activity will also be measured using a scoring system called DAS28-CRP, which combines joint counts with a blood test measuring inflammation.

    You will complete a questionnaire called the Health Assessment Questionnaire Disability Index, which evaluates your ability to perform daily activities.

  4. Step 4

    Safety monitoring throughout the study

    Throughout the entire study period, you will be monitored for any adverse events, which are any unwanted or unexpected medical occurrences.

    If you experience any side effects or health changes, these will be recorded and evaluated.

    The study team will determine if any adverse events are related to the study medication.

  5. Step 5

    Continuation of study participation

    The study will continue beyond Week 12 with additional visits and assessments.

    You will continue receiving the assigned treatment and attending scheduled visits.

    The total duration of your participation will extend until the study reaches its completion, which is estimated to be in March 2027.

  6. Step 6

    End of study

    At the conclusion of the study, a final assessment will be performed.

    The study medication will be discontinued, and arrangements will be made for your ongoing care.

    All collected information will be used to evaluate the effectiveness and safety of tulisokibart in treating rheumatoid arthritis.

Who can join the trial?

8 criteria

  • You must have a confirmed medical diagnosis of rheumatoid arthritis, which is a condition where your immune system attacks your joints causing pain and swelling, and you must meet the specific classification rules set by medical organizations in 2010
  • You must currently be taking a medicine called methotrexate, which is a drug used to reduce inflammation and slow down joint damage in rheumatoid arthritis
  • You must have been taking methotrexate for at least 12 weeks before joining the study
  • You must have been taking the same steady dose of methotrexate for at least 4 weeks before joining the study
  • Your weekly dose of methotrexate must be between 15 milligrams and 25 milligrams per week, or at least 10 milligrams per week if you cannot tolerate higher doses after your doctor has tried to gradually increase the amount
  • You can take methotrexate either by mouth as a tablet or by injection under the skin or into a muscle
  • You can be male or female to participate in this study
  • You must be an adult to participate in this study

Who cannot join the trial?

4 criteria

  • The study does not provide specific exclusion criteria information in the available data
  • Patients should discuss with their doctor whether they are eligible to participate in this study
  • General factors that typically prevent participation in rheumatoid arthritis (a condition where the body's immune system attacks the joints causing pain and swelling) studies may include having other serious medical conditions, being pregnant or breastfeeding, or taking certain medications that could interfere with the study treatment
  • Your doctor will review your complete medical history to determine if this study is appropriate for you
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Investigated drugs

  • Tulisokibart

    is an investigational medication being studied for the treatment of rheumatoid arthritis. This medicine is designed to help reduce inflammation and symptoms associated with this condition, which causes joint pain, swelling, and stiffness.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of tulisokibart against no treatment, helping researchers determine if the medication is truly effective.

What is already known about the treatment

Tulisokibart – Tulisokibart is an experimental medication currently being studied in Phase 2b clinical trials for the treatment of rheumatoid arthritis, a chronic condition where the body's immune system attacks the joints causing pain, swelling, and stiffness. This drug is administered to help reduce joint inflammation and improve symptoms in patients who suffer from this autoimmune disease. Tulisokibart works at the molecular level by targeting specific proteins involved in the inflammatory process that damages joints in rheumatoid arthritis. The medication belongs to the class of biological therapies, which are designed to modify the immune system's response and prevent it from attacking healthy joint tissue.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a long-term condition where the body's immune system mistakenly attacks the joints, causing inflammation. It typically affects the small joints in the hands and feet first, but can spread to other joints throughout the body. The disease causes pain, swelling, stiffness, and warmth in the affected joints, especially in the morning or after periods of rest. Over time, the ongoing inflammation can damage the joint tissues, cartilage, and bone, leading to joint deformity and reduced mobility. The condition often progresses in phases, with periods of increased symptoms called flares alternating with times of fewer symptoms. Beyond the joints, rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, lungs, heart, and blood vessels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521745-25-00Protocol codeMK-7240-014Estimated enrolment177 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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