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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07176390
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Sharp & Dohme LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Merck Sharp & Dohme LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Japan, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis, Rheumatoid
Study Website:	View Trial Website

Additional Details

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

Arms & Interventions

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.

Interventions

Drug: - Tulisokibart

Subcutaneous (SC) administration

Drug: - Placebo

SC Injection

Drug: - Methotrexate

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Glendale 5295985, Arizona 5551752

Status

Recruiting

Address

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

Glendale 5295985, Arizona 5551752, 85306-9802

Site Contact

Study Coordinator

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