Status:
RECRUITING
A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2029
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT07176390
Start Date
October 8 2025
End Date
September 3 2029
Last Update
December 26 2025
Active Locations (42)
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1
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale, Arizona, United States, 85306-9802
2
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa, Arizona, United States, 85210
3
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma, California, United States, 90623
4
Tekton Research, LLC. ( Site 1008)
Fort Collins, Colorado, United States, 80528