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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07176390
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Oct 8, 2025
Status verified
May 2026
Primary completion
Mar 8, 2027
Completion
Sep 3, 2029

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose tulisokibart
    Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
  • Experimental: Medium-dose tulisokibart
    Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.
  • Experimental: Low-dose tulisokibart
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 [ Time Frame: Week 12 ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)GlendaleArizona85306-9802
Study Coordinator
480-443-8400
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)MesaArizona85210
Study Coordinator
480-443-8400
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)La PalmaCalifornia90623
Study Coordinator
714-670-1340
Tekton Research, LLC. ( Site 1008)Fort CollinsColorado80528
Study Coordinator
970-775-8922
Sweet Hope Research Specialty, Inc ( Site 1015)HialeahFlorida33016
Study Coordinator
305-456-9062
HMD Research LLC ( Site 1016)OrlandoFlorida32819
Study Coordinator
407-612-6300
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)Orland ParkIllinois60467
Study Coordinator
847-599-2492
AA Medical Research Center ( Site 1027)Grand BlancMichigan48439
Study Coordinator
810-694-0082
Kansas City Physician Partners ( Site 1032)Kansas CityMissouri64111
Study Coordinator
816-384-2827
Physician Research Collaboration, LLC ( Site 1002)LincolnNebraska68516
Study Coordinator
402-420-3433
altoona center for clinical research ( Site 1005)DuncansvillePennsylvania16635
Study Coordinator
814-693-0300
Rheumatology Specialty Center ( Site 1030)Willow GrovePennsylvania19090
Study Coordinator
215-657-6950
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)MurfreesboroTennessee37128
Study Coordinator
615-236-2504
Rheumatology Associates ( Site 1026)ArlingtonTexas76012
Study Coordinator
214-540-0700
Epic Medical Research ( Site 1004)Red OakTexas75154
Study Coordinator
972-777-6956
Advanced Rheumatology of Houston - Woodlands ( Site 1000)The WoodlandsTexas77382
Study Coordinator
281-673-6886

Find similar trials in Glendale, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Arizona Arthritis & Rheumatology Associates, P.C.· Glendale, AZAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa· Mesa, AZArthritis & Osteoporosis Medical Center - La Palma· La Palma, CATekton Research, LLC.· Fort Collins, COSweet Hope Research Specialty, Inc· Hialeah, FLHMD Research LLC· Orlando, FL

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