NCT07176390

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Tulisokibart	Subcutaneous (SC) administration
DRUG	Placebo	SC Injection
DRUG	Methotrexate	Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

Timeline

• Start date: 2025-10-08
• Primary completion: 2027-03-08
• Completion: 2029-09-03
• First posted: 2025-09-16
• Last updated: 2026-02-20

Locations

61 sites across 11 countries: United States, Canada, Chile, China, Colombia, Germany, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study