A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Arthritis, Rheumatoid
In brief
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.
Key facts
- Study ID
- NCT07176390
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 182
- Starts
- 2025-10-08
- Expected to finish
- 2029-03-03
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033) — Mesa, Arizona, United States
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024) — La Palma, California, United States
- Tekton Research, LLC. ( Site 1008) — Fort Collins, Colorado, United States
- Sweet Hope Research Specialty, Inc ( Site 1015) — Hialeah, Florida, United States
- HMD Research LLC ( Site 1016) — Orlando, Florida, United States
- Greater Chicago Specialty Physicians - Orland Park ( Site 1043) — Orland Park, Illinois, United States
- AA Medical Research Center ( Site 1027) — Grand Blanc, Michigan, United States
- Kansas City Physician Partners ( Site 1032) — Kansas City, Missouri, United States
- Physician Research Collaboration, LLC ( Site 1002) — Lincoln, Nebraska, United States
- altoona center for clinical research ( Site 1005) — Duncansville, Pennsylvania, United States
- Rheumatology Specialty Center ( Site 1030) — Willow Grove, Pennsylvania, United States
- AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034) — Murfreesboro, Tennessee, United States
- Rheumatology Associates ( Site 1026) — Arlington, Texas, United States
- Epic Medical Research ( Site 1004) — Red Oak, Texas, United States
- Advanced Rheumatology of Houston - Woodlands ( Site 1000) — The Woodlands, Texas, United States
- Mount Sinai Hospital ( Site 1102) — Toronto, Ontario, Canada
- CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106) — Sherbrooke, Quebec, Canada
- Centre de Recherche Musculo-Squelettique ( Site 1101) — Trois-Rivières, Quebec, Canada
- Centro de Estudios GyC ( Site 1206) — Santiago, Region M. de Santiago, Chile
- Clinica Dermacross ( Site 1203) — Santiago, Region M. de Santiago, Chile
- CECIM ( Site 1208) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile-CICUC ( Site 1209) — Santiago, Region M. de Santiago, Chile
- Peking University First Hospital ( Site 2511) — Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Xiamen University. ( Site 2510) — Xiamen, Fujian, China
- Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018) — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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