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

Conditions

• Arthritis, Rheumatoid

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

Jun 2026

Primary completion

Sep 5, 2026

Completion

Mar 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 ]

Locations (16)

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