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Tulisokibart (MK-7240) with methotrexate for active rheumatoid arthritis

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT07176390

This 12-week trial will test whether adding tulisokibart (MK-7240) to methotrexate helps people with active rheumatoid arthritis reduce joint pain and swelling.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsmethotrexate
Locations62 sites (Glendale, Arizona and 61 other locations)
Trial IDNCT07176390 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo-controlled trial compares several doses of tulisokibart (MK-7240) versus placebo over a 12-week double-blind period in people with active RA who are already taking methotrexate. Participants must have active disease (≥6 tender and ≥6 swollen joints) and may be biologic-naïve or have had inadequate response/intolerance to up to two classes of biologic DMARDs. After the 12-week placebo-controlled period, eligible participants can enter a 116-week long-term extension (44-week main extension plus a 72-week optional extension) to continue receiving active treatment. The study is sponsored by Merck and is being run at several U.S. rheumatology clinical sites.

Who should consider this trial

Good fit: Adults with active rheumatoid arthritis on stable oral or parenteral methotrexate who have at least 6 tender and 6 swollen joints and are either biologic-naïve or have had inadequate response or intolerance to up to two classes of biologic DMARDs are ideal candidates.

Not a fit: People with arthritis beginning before age 17, those with other inflammatory joint diseases (for example psoriatic arthritis or lupus), or those who cannot take methotrexate are unlikely to benefit from participating in this protocol.

Why it matters

Potential benefit: If successful, tulisokibart could become an additional treatment option that reduces joint pain and swelling for people whose RA is not fully controlled on methotrexate.

How similar studies have performed: Other targeted RA treatments, including biologics and JAK inhibitors, have shown benefit in similar patient groups, while tulisokibart itself is a newer investigational agent being tested here in a Phase 2 dose-ranging trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
* Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
* Has current treatment with oral or parenteral methotrexate (MTX) therapy
* Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA
* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before randomization
* Has any active infection
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Where this trial is running

Glendale, Arizona and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Arthritis, Rheumatoid
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.