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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Tulisokibart; Drug: Placebo; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07176390

2025-521745-25-00 (Registry Identifier)

U1111-1320-8718 (Registry Identifier)

MK-7240-014 (Other Identifier)

7240-014

Details and patient eligibility

About

Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people.

This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart.

Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

Full description

This study consists of a 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 72-week Optional Extension

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

182 participants in 4 patient groups, including a placebo group

High-dose tulisokibart

Experimental group

Description:

Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart

Treatment:

Drug: Methotrexate

Drug: Tulisokibart

Medium-dose tulisokibart

Experimental group

Description:

Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.

Treatment:

Drug: Methotrexate

Drug: Tulisokibart

Low-dose tulisokibart

Experimental group

Description:

Participants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.

Treatment:

Drug: Methotrexate

Drug: Tulisokibart

Placebo

Placebo Comparator group

Description:

Participants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.

Treatment:

Drug: Methotrexate

Drug: Placebo