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NCT07486960PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

4/20/2026

Completion Date

1/11/2030

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.

Detailed Description

This study consists of a 16-week Placebo-controlled Period and a 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-week Optional Extension.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Tulisokibart

DRUG

Placebo

Interested in This Trial?

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Conditions

Psoriatic Arthritis

Locations

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

Sun City, Arizona 85351

United States

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

Tucson, Arizona 85704-1140

United States

Medvin Clinical Research - Riverside ( Site 5115)

Riverside, California 92508

United States

Cohen Medical Centers ( Site 5111)

Thousand Oaks, California 91360

United States

Medvin Clinical Research - Tujunga ( Site 5113)

Tujunga, California 91042

United States

Arthritis and Rheumatic Disease Specialties ( Site 5105)

Aventura, Florida 33180

United States

International Center for Research ( Site 5124)

Tampa, Florida 33618

United States

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

Boise, Idaho 83702-4565

United States

Arthritis and Rheumatism Associates - Rockville ( Site 5127)

Rockville, Maryland 20850

United States

Kansas City Physician Partners ( Site 5119)

Kansas City, Missouri 64111

United States

Physician Research Collaboration, LLC ( Site 5102)

Lincoln, Nebraska 68516

United States

Joint and Muscle Research Institute ( Site 5108)

Charlotte, North Carolina 28204

United States

Altoona Center for Clinical Research ( Site 5110)

Duncansville, Pennsylvania 16635

United States

Hospital of the University of Pennsylvania ( Site 5134)

Philadelphia, Pennsylvania 19104

United States

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

Summerville, South Carolina 29486

United States

Greater Houston Rheumatology ( Site 5103)

Houston, Texas 77095

United States

Centre Rhumatologie De L'Est ( Site 5201)

Rimouski, Quebec G5L 8W1

Canada

Centre de Recherche Musculo-Squelettique ( Site 5202)

Trois-Rivières, Quebec G9A 3Y2

Canada

Centro de Estudios GyC ( Site 8206)

Santiago, Region M. de Santiago 7500504

Chile

Enroll SpA ( Site 8203)

Santiago, Region M. de Santiago 7500587

Chile

Clinica Dermacross ( Site 8200)

Santiago, Region M. de Santiago 7640881

Chile

CECIM ( Site 8205)

Santiago, Region M. de Santiago 8331143

Chile

Centro Internacional de Estudios Clinicos (CIEC) ( Site 8201)

Santiago, Region M. de Santiago 8420383

Chile

Clinica de la Costa S.A.S. ( Site 8301)

Barranquilla, Atlántico 080020

Colombia

Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8306)

Bogota, Cundinamarca 110221

Colombia

Fundación Valle del Lili ( Site 8302)

Cali, Valle del Cauca Department 760032

Colombia

Rheuma-Research Lausitz ( Site 6409)

Cottbus, Brandenburg 03042

Germany

Rheumazentrum Ruhrgebiet ( Site 6400)

Herne, North Rhine-Westphalia 44649

Germany

Rheumatologische Schwerpunktpraxis ( Site 6405)

Berlin, 10777

Germany

HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 6404)

Hamburg, 20095

Germany

MICS Centrum Medyczne Bydgoszcz ( Site 6907)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065

Poland

MICS Centrum Medyczne Torun ( Site 6903)

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901)

Lublin, Lubusz Voivodeship 20-607

Poland

MICS Centrum Medyczne Warszawa ( Site 6905)

Warsaw, Masovian Voivodeship 00-874

Poland

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 6906)

Warsaw, Masovian Voivodeship 02-637

Poland

CHUS - Hospital Clinico Universitario ( Site 7102)

Santiago de Compostela, La Coruna 15706

Spain

Hospital Vall d' Hebron ( Site 7101)

Barcelona, 08029

Spain

Hospital Viamed Santa Elena ( Site 7105)

Madrid, 28003

Spain

Hospital Universitario la Fe ( Site 7107)

Valencia, 46026

Spain

Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 7401)

Kiev, Kyiv Oblast 03049

Ukraine

Edelweiss Medics ( Site 7409)

Kyiv, Kyivska Oblast 02002

Ukraine

Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 7415)

Kyiv, Kyivska Oblast 04050

Ukraine

Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 7410)

Lviv, Lviv Oblast 79011

Ukraine

Limited liability company "Medical center Health Clinic" ( Site 7412)

Vinnytsia, Vinnytsia Oblast 21009

Ukraine

Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 7400)

Vinnytsia, Vinnytsia Oblast 21028

Ukraine

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 7406)

Kyiv, 03057

Ukraine