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Arthritis, RheumatoidPhase 2NCT07176390

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

A Phase 2 study testing Tulisokibart and Methotrexate in people with Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC at 61 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 RA symptoms for many people. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Tulisokibart and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
61 sitesin 11 countries
Study dates
8 Oct 2025to 1 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

61 sites in 11 countries.

61 sites in 11 countries

United States16 sites

  • Rheumatology Associates ( Site 1026)

    Arlington, Texas, 76012

  • altoona center for clinical research ( Site 1005)

    Duncansville, Pennsylvania, 16635

  • Tekton Research, LLC. ( Site 1008)

    Fort Collins, Colorado, 80528

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

    Glendale, Arizona, 85306-9802

  • AA Medical Research Center ( Site 1027)

    Grand Blanc, Michigan, 48439

  • Sweet Hope Research Specialty, Inc ( Site 1015)

    Hialeah, Florida, 33016

  • Kansas City Physician Partners ( Site 1032)

    Kansas City, Missouri, 64111

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

    La Palma, California, 90623

  • Physician Research Collaboration, LLC ( Site 1002)

    Lincoln, Nebraska, 68516

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

    Mesa, Arizona, 85210

  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)

    Murfreesboro, Tennessee, 37128

  • Greater Chicago Specialty Physicians - Orland Park ( Site 1043)

    Orland Park, Illinois, 60467

  • HMD Research LLC ( Site 1016)

    Orlando, Florida, 32819

  • Epic Medical Research ( Site 1004)

    Red Oak, Texas, 75154

  • Advanced Rheumatology of Houston - Woodlands ( Site 1000)

    The Woodlands, Texas, 77382

  • Rheumatology Specialty Center ( Site 1030)

    Willow Grove, Pennsylvania, 19090

Other trials in United States

China8 sites

  • Peking University First Hospital ( Site 2511)

    Beijing, Beijing Municipality, 100034

  • The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)

    Guangzhou, Guangdong, 510630

  • Linfen Central Hospital ( Site 2507)

    Linfen, Shanxi, 041000

  • Taizhou Hospital of Zhejiang Province ( Site 2506)

    Linhai, Zhejiang, 317000

  • Pingxiang People's Hospital ( Site 2512)

    Pingxiang, Jiangxi, 337000

  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Xiamen University. ( Site 2510)

    Xiamen, Fujian, 361003

  • Xinxiang Central Hospital ( Site 2501)

    Xinxiang, Henan, 453000

Other trials in China

Poland7 sites

  • MICS Centrum Medyczne Bydgoszcz ( Site 1807)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • NZOZ BIF-MED ( Site 1802)

    Bytom, Silesian Voivodeship, 41-902

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

    Lublin, Lublin Voivodeship, 20-607

  • MICS Centrum Medyczne Torun ( Site 1803)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • MICS Centrum Medyczne Warszawa ( Site 1805)

    Warsaw, Masovian Voivodeship, 00-874

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)

    Warsaw, Masovian Voivodeship, 02-637

Other trials in Poland

Japan6 sites

  • University of Yamanashi Hospital ( Site 2603)

    Chūō, Yamanashi, 409-3898

  • Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)

    Hanishina-gun, Nagano, 389-0606

  • Kai Clinic ( Site 2600)

    Miyazaki, 880-0053

  • Nagaoka Red Cross Hospital ( Site 2604)

    Nagaoka, Niigata, 940-2085

  • Sasebo Chuo Hospital ( Site 2602)

    Sasebo, Nagasaki, 857-1195

  • Hirose Clinic ( Site 2601)

    Tokorozawa, Saitama, 359-1111

Other trials in Japan

Germany5 sites

  • Rheumatologische Schwerpunktpraxis ( Site 1603)

    Berlin, 12161

  • Rheuma-Research Lausitz ( Site 1604)

    Cottbus, Brandenburg, 03042

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)

    Hamburg, 20095

  • Medicover München Ost MVZ ( Site 1607)

    München, Bavaria, 81667

  • Rheumazentrum Ratingen Studienambulanz ( Site 1601)

    Ratingen, North Rhine-Westphalia, 40878

Other trials in Germany

Chile4 sites

  • Centro de Estudios GyC ( Site 1206)

    Santiago, Region M. de Santiago, 7500504

  • Clinica Dermacross ( Site 1203)

    Santiago, Region M. de Santiago, 7640881

  • CECIM ( Site 1208)

    Santiago, Region M. de Santiago, 8320000

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)

    Santiago, Region M. de Santiago, 8330073

Other trials in Chile

Spain4 sites

  • Hospital Universitari Vall d'Hebron ( Site 1901)

    Barcelona, 08035

  • Hospital Universitari Parc Tauli ( Site 1900)

    Sabadell, Barcelona, 8208

  • Hospital Universitario Marqués de Valdecilla ( Site 1906)

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Santiago ( Site 1903)

    Santiago de Compostela, La Coruna, 15706

Other trials in Spain

Colombia3 sites

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

    Barranquilla, Atlántico, 080020

  • CIREEM SAS ( Site 1304)

    Bogota, Cundinamarca, 110111

  • Fundación Valle del Lili ( Site 1305)

    Cali, Valle del Cauca Department, 760032

Other trials in Colombia

South Korea3 sites

  • Soon Chun Hyang University Cheonan Hospital ( Site 2304)

    Cheonan-si, Chungcheongnam-do, 31151

  • Chungnam national university hospital ( Site 2303)

    Daejeon, Taejon-Kwangyokshi, 35015

  • Hanyang University Seoul Hospital ( Site 2300)

    Seoul, 04763

Other trials in South Korea

United Kingdom3 sites

  • The Princess Alexandra Hospital NHS Trust ( Site 2103)

    Harlow, England, CM20 1QX

  • Chapel Allerton Hospital ( Site 2106)

    Leeds, LS7 4SA

  • Barnet Hospital ( Site 2102)

    London, EN5 3DJ

Other trials in United Kingdom

Canada2 sites

  • CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)

    Sherbrooke, Quebec, J1G 2E8

  • Centre de Recherche Musculo-Squelettique ( Site 1101)

    Trois-Rivières, Quebec, G9A 3X2

Other trials in Canada

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis

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.

Read the 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

Being tested
Tulisokibart, Placebo, Methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TulisokibartDrug

    Also called MK-7240, PRA023

    Subcutaneous (SC) administration

  • PlaceboDrug

    SC Injection

  • MethotrexateDrug

    Also called MTX

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

Study groups in NCT07176390
Study groupRoleWhat they receive
High-dose tulisokibartExperimentalParticipants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
Receives: Drug: Tulisokibart; Drug: Methotrexate
Medium-dose tulisokibartExperimentalParticipants receive background therapy of MTX PLUS a medium dose of tulisokibart.
Receives: Drug: Tulisokibart; Drug: Methotrexate
Low-dose tulisokibartExperimentalParticipants 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.
Receives: Drug: Tulisokibart; Drug: Methotrexate
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12

    The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.

    Measured: Week 12

Secondary outcomes (6)

  1. Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12

    The ACR50 response is a composite measure to evaluate disease activity in RA. ACR50 response is defined as a ≥50% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥50% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0= without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR50 response at Week 12 will be presented.

    Measured: Week 12

  2. Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12

    The ACR70 response is a composite measure to evaluate disease activity in RA. ACR70 response is defined as a ≥70% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥70% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0= without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR70 response at Week 12 will be presented.

    Measured: Week 12

  3. Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)

    The DAS28-CRP is a composite measure of RA disease activity. DAS28-CRP is based upon a statistically-derived index combining the following 4 components: i) tender joint count (TJC) (28 joints; 0=absent, 1=present; TJC28), ii) swollen joint count (SJC) (28 joints; 0=absent, 1=present; SJC28), iii) serum high-sensitivity C-reactive protein (hsCRP), serum value decrease indicates less inflammation, and iv) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease. The index is defined as follows: DAS28-CRP = 0.56 × SQRT(TJC28) + 0.28 × SQRT(SJC28) + 0.36 × ln (hsCRP+1) + 0.014 × ptGA+ 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Remission is indicated by a DAS28-CRP score of <2.6 and low disease activity (LDA) by a DAS28-CRP score of ≤3.2. The proportion of participants who achieve LDA will be presented.

    Measured: Week 12

  4. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12

    The HAQ-DI is a 20-item questionnaire that measures physical function in participants with RA. The questionnaire assesses the degree of difficulty a person has in accomplishing tasks in 8 functional area domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area domain are scored from 0 to 3 (0= without any difficulty; 3= unable to do), with a higher score indicating inability to perform activity. The overall disability score (HAQ-DI) is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3, with the higher value indicating worse disability. The change from baseline to week 12 in the HAQ-DI score will be presented.

    Measured: Baseline and Week 12

  5. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately Week 142

  6. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately Week 128

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start8 Oct 2025
  3. Primary completion7 Sep 2026
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176390
Sponsor's protocol ID
7240-014
Other IDs
U1111-1320-8718, 2025-521745-25-00, MK-7240-014, 2025
Status last verified
Sep 2026
First submitted
9 Sep 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tulisokibart and Methotrexate in people with Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC at 61 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, China, Poland, Japan, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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