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

NCT07486960 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 7240-015U1111-1318-43012025-520997-21-00
• Study Type: interventional
• Target: 140
• Locations: 8 countries
• Sites: 46

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16

  ACR20 response is defined as a ≥20% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥20% improvement in ≥3 of 5 components: 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) blood values (lower value indicates less inflammation).

  Week 16

Secondary Outcomes (5)

• Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16

  Week 16

• Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16

  Week 16

• Change from Baseline in HAQ-DI Score at Week 16

  Baseline and Week 16

• Number of Participants with ≥1 Adverse Event

  Up to approximately Week 142

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately Week 128

Study Arms (4)

High-Dose Regimen

EXPERIMENTAL

Participants receive a high dose of tulisokibart.

Drug: Tulisokibart

Medium-Dose Regimen

EXPERIMENTAL

Participants receive a medium dose of tulisokibart.

Drug: Tulisokibart

Low-Dose Regimen

EXPERIMENTAL

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

Drug: Tulisokibart

Placebo Regimen

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tulisokibart DRUG

Subcutaneous administration

Also known as: MK-7240, PRA023

High-Dose Regimen; Low-Dose Regimen; Medium-Dose Regimen

Placebo DRUG

Subcutaneous administration

Placebo Regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (46)

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

Sun City, Arizona, 85351, United States

RECRUITING

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

Tucson, Arizona, 85704-1140, United States

RECRUITING

Medvin Clinical Research - Riverside ( Site 5115)

Riverside, California, 92508, United States

RECRUITING

Cohen Medical Centers ( Site 5111)

Thousand Oaks, California, 91360, United States

RECRUITING

Medvin Clinical Research - Tujunga ( Site 5113)

Tujunga, California, 91042, United States

RECRUITING

Arthritis and Rheumatic Disease Specialties ( Site 5105)

Aventura, Florida, 33180, United States

RECRUITING

International Center for Research ( Site 5124)

Tampa, Florida, 33618, United States

RECRUITING

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

Boise, Idaho, 83702-4565, United States

RECRUITING

Arthritis and Rheumatism Associates - Rockville ( Site 5127)

Rockville, Maryland, 20850, United States

RECRUITING

Kansas City Physician Partners ( Site 5119)

Kansas City, Missouri, 64111, United States

RECRUITING

Physician Research Collaboration, LLC ( Site 5102)

Lincoln, Nebraska, 68516, United States

RECRUITING

Joint and Muscle Research Institute ( Site 5108)

Charlotte, North Carolina, 28204, United States

RECRUITING

Altoona Center for Clinical Research ( Site 5110)

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Hospital of the University of Pennsylvania ( Site 5134)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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

Summerville, South Carolina, 29486, United States

RECRUITING

Greater Houston Rheumatology ( Site 5103)

Houston, Texas, 77095, United States

RECRUITING

Centre Rhumatologie De L'Est ( Site 5201)

Rimouski, Quebec, G5L 8W1, Canada

RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 5202)

Trois-Rivières, Quebec, G9A 3Y2, Canada

RECRUITING

Centro de Estudios GyC ( Site 8206)

Santiago, Region M. de Santiago, 7500504, Chile

RECRUITING

Enroll SpA ( Site 8203)

Santiago, Region M. de Santiago, 7500587, Chile

RECRUITING

Clinica Dermacross ( Site 8200)

Santiago, Region M. de Santiago, 7640881, Chile

RECRUITING

CECIM ( Site 8205)

Santiago, Region M. de Santiago, 8331143, Chile

RECRUITING

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

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

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

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

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

Bogota, Cundinamarca, 110221, Colombia

RECRUITING

Fundación Valle del Lili ( Site 8302)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Rheuma-Research Lausitz ( Site 6409)

Cottbus, Brandenburg, 03042, Germany

RECRUITING

Rheumazentrum Ruhrgebiet ( Site 6400)

Herne, North Rhine-Westphalia, 44649, Germany

RECRUITING

Rheumatologische Schwerpunktpraxis ( Site 6405)

Berlin, 10777, Germany

RECRUITING

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

Hamburg, 20095, Germany

RECRUITING

MICS Centrum Medyczne Bydgoszcz ( Site 6907)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland

RECRUITING

MICS Centrum Medyczne Torun ( Site 6903)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

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

Lublin, Lubusz Voivodeship, 20-607, Poland

RECRUITING

MICS Centrum Medyczne Warszawa ( Site 6905)

Warsaw, Masovian Voivodeship, 00-874, Poland

RECRUITING

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

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

CHUS - Hospital Clinico Universitario ( Site 7102)

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

Hospital Vall d' Hebron ( Site 7101)

Barcelona, 08029, Spain

RECRUITING

Hospital Viamed Santa Elena ( Site 7105)

Madrid, 28003, Spain

RECRUITING

Hospital Universitario la Fe ( Site 7107)

Valencia, 46026, Spain

RECRUITING

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

Kiev, Kyiv Oblast, 03049, Ukraine

RECRUITING

Edelweiss Medics ( Site 7409)

Kyiv, Kyivska Oblast, 02002, Ukraine

RECRUITING

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

Kyiv, Kyivska Oblast, 04050, Ukraine

RECRUITING

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

Lviv, Lviv Oblast, 79011, Ukraine

RECRUITING

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

Vinnytsia, Vinnytsia Oblast, 21009, Ukraine

RECRUITING

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

Vinnytsia, Vinnytsia Oblast, 21028, Ukraine

RECRUITING

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

Kyiv, 03057, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 23, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): August 13, 2027
• Study Completion (Estimated): January 11, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (16); CA (2); CL (5); UA (7); DE (4); CO (3); ES (4); PL (5)