Recruiting

Phase 2

TulisokibartStudy to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07486960

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tulisokibart

Placebo

Study Details

Brief summary:

Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.

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 PsA 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.

Conditions

Psoriatic Arthritis

Study ID

NCT07486960

Start date

Apr 20, 2026

Status verified date

Aug, 2026

Completion date

Jan 11, 2030

Anticipated

Primary completion date

Aug 13, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.
Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant.

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 PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.
Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.
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 of its excipients.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-Dose Regimen

Participants receive a high dose of tulisokibart.

experimental: Medium-Dose Regimen

Participants receive a medium dose of tulisokibart.

experimental: Low-Dose Regimen

Participants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart.

placebo comparator: Placebo Regimen

Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart.

Interventions

Tulisokibart

Subcutaneous administration

Placebo

Subcutaneous administration

Primary outcome measure

Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117)

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Study Coordinator

480-443-8400

Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)

Recruiting

Tucson, Arizona, United States, 85704-1140

Contacts

Study Coordinator

480-443-8400

Medvin Clinical Research - Riverside ( Site 5115)

Recruiting

Riverside, California, United States, 92508

Contacts

Study Coordinator

951-924-6500

Cohen Medical Centers ( Site 5111)

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Study Coordinator

877-972-7576

Medvin Clinical Research - Tujunga ( Site 5113)

Recruiting

Tujunga, California, United States, 91042

Contacts

Study Coordinator

213-281-5146

Arthritis and Rheumatic Disease Specialties ( Site 5105)

Recruiting

Aventura, Florida, United States, 33180

Contacts

Study Coordinator

305-652-6676

International Center for Research ( Site 5124)

Recruiting

Tampa, Florida, United States, 33618

Contacts

Study Coordinator

813-392-1103

St. Luke's Clinic - Rheumatology - Boise ( Site 5109)

Recruiting

Boise, Idaho, United States, 83702-4565

Contacts

Study Coordinator

208-706-9088

Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center ( Site 5132)

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Study Coordinator

410-550-0579

Arthritis and Rheumatism Associates - Rockville ( Site 5127)

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Study Coordinator

240-283-2046

Kansas City Physician Partners ( Site 5119)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-531-0930

Physician Research Collaboration, LLC ( Site 5102)

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

Study Coordinator

402-420-1212

Joseph S. and Diane H. Steinberg Ambulatory Care Center ( Site 5106)

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Study Coordinator

929-455-2500

Joint and Muscle Research Institute ( Site 5108)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

704-248-8577

Altoona Center for Clinical Research ( Site 5110)

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Study Coordinator

814-693-0300

Hospital of the University of Pennsylvania ( Site 5134)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-662-2454

Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)

Recruiting

Summerville, South Carolina, United States, 29486

Contacts

Study Coordinator

843-572-4840

Greater Houston Rheumatology ( Site 5103)

Recruiting

Houston, Texas, United States, 77095

Contacts

Study Coordinator

832-237-0400

Centre Rhumatologie De L'Est ( Site 5201)

Recruiting

Rimouski, Quebec, Canada, G5L 8W1

Contacts

Study Coordinator

418 723 2445

Centre de Recherche Musculo-Squelettique ( Site 5202)

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3Y2

Contacts

Study Coordinator

819-370-1301

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-10.