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

NCT ID: NCT07176390

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2029-09-03

Brief Summary

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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

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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

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Medium-dose tulisokibart

Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Methotrexate

Intervention Type DRUG

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

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.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Methotrexate

Intervention Type DRUG

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC Injection

Methotrexate

Intervention Type DRUG

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

High-dose tulisokibart

Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Methotrexate

Intervention Type DRUG

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

Interventions

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Tulisokibart

Subcutaneous (SC) administration

Intervention Type DRUG

Placebo

SC Injection

Intervention Type DRUG

Methotrexate

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

Intervention Type DRUG

Other Intervention Names

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MK-7240 PRA023 MTX

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)

Glendale, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)

Mesa, Arizona, United States

Site Status RECRUITING

Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)

La Palma, California, United States

Site Status RECRUITING

Tekton Research, LLC. ( Site 1008)

Fort Collins, Colorado, United States

Site Status RECRUITING

Sweet Hope Research Specialty, Inc ( Site 1015)

Hialeah, Florida, United States

Site Status RECRUITING

HMD Research LLC ( Site 1016)

Orlando, Florida, United States

Site Status RECRUITING

Greater Chicago Specialty Physicians - Orland Park ( Site 1043)

Orland Park, Illinois, United States

Site Status RECRUITING

AA Medical Research Center ( Site 1027)

Grand Blanc, Michigan, United States

Site Status RECRUITING

Kansas City Physician Partners ( Site 1032)

Kansas City, Missouri, United States

Site Status RECRUITING

Physician Research Collaboration, LLC ( Site 1002)

Lincoln, Nebraska, United States

Site Status RECRUITING

altoona center for clinical research ( Site 1005)

Duncansville, Pennsylvania, United States

Site Status RECRUITING

Rheumatology Specialty Center ( Site 1030)

Willow Grove, Pennsylvania, United States

Site Status RECRUITING

AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)

Murfreesboro, Tennessee, United States

Site Status RECRUITING

Rheumatology Associates ( Site 1026)

Arlington, Texas, United States

Site Status RECRUITING

Epic Medical Research ( Site 1004)

Red Oak, Texas, United States

Site Status RECRUITING

Advanced Rheumatology of Houston - Woodlands ( Site 1000)

The Woodlands, Texas, United States

Site Status RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 1101)

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

Clinica de la Costa S.A.S. ( Site 1301)

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

CIREEM SAS ( Site 1304)

Bogota, Cundinamarca, Colombia

Site Status RECRUITING

Fundación Valle del Lili ( Site 1305)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Rheumatologische Schwerpunktpraxis ( Site 1603)

Berlin, , Germany

Site Status RECRUITING

Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)

Hanishina-gun, Nagano, Japan

Site Status RECRUITING

Sasebo Chuo Hospital ( Site 2602)

Sasebo, Nagasaki, Japan

Site Status RECRUITING

Nagaoka Red Cross Hospital ( Site 2604)

Nagaoka, Niigata, Japan

Site Status RECRUITING

Hirose Clinic ( Site 2601)

Tokorozawa, Saitama, Japan

Site Status RECRUITING

University of Yamanashi Hospital ( Site 2603)

Chūō, Yamanashi, Japan

Site Status RECRUITING

Kai Clinic ( Site 2600)

Miyazaki, , Japan

Site Status RECRUITING

MICS Centrum Medyczne Bydgoszcz ( Site 1807)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

MICS Centrum Medyczne Torun ( Site 1803)

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

MICS Centrum Medyczne Warszawa ( Site 1805)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

NZOZ BIF-MED ( Site 1802)

Bytom, Silesian Voivodeship, Poland

Site Status RECRUITING

Soon Chun Hyang University Cheonan Hospital ( Site 2304)

Cheonan-si, Chungcheongnam-do, South Korea

Site Status RECRUITING

Chungnam national university hospital ( Site 2303)

Daejeon, Taejon-Kwangyokshi, South Korea

Site Status RECRUITING

Hospital Universitari Parc Tauli ( Site 1900)

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital Clinico Universitario de Santiago ( Site 1903)

Santiago de Compostela, La Coruna, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron ( Site 1901)

Barcelona, , Spain

Site Status RECRUITING

The Princess Alexandra Hospital NHS Trust ( Site 2103)

Harlow, England, United Kingdom

Site Status RECRUITING

Chapel Allerton Hospital ( Site 2106)

Leeds, , United Kingdom

Site Status RECRUITING

Barnet Hospital ( Site 2102)

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Canada Colombia Germany Japan Poland South Korea Spain United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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U1111-1320-8718

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-521745-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-7240-014

Identifier Type: OTHER

Identifier Source: secondary_id

7240-014

Identifier Type: -

Identifier Source: org_study_id