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

NCT07486960 · Merck Sharp & Dohme LLC
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Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
About this study
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
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 target: 140 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-20
Estimated completion: 2030-01-11
Last updated: 2026-06-01
Interventions
Drug: TulisokibartDrug: Placebo
Primary outcomes
  • Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16 (Week 16)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (38)
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117)Recruiting
Sun City, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)Recruiting
Tucson, Arizona, United States
Medvin Clinical Research - Riverside ( Site 5115)Recruiting
Riverside, California, United States
Cohen Medical Centers ( Site 5111)Recruiting
Thousand Oaks, California, United States
Medvin Clinical Research - Tujunga ( Site 5113)Recruiting
Tujunga, California, United States
Arthritis and Rheumatic Disease Specialties ( Site 5105)Recruiting
Aventura, Florida, United States
International Center for Research ( Site 5124)Recruiting
Tampa, Florida, United States
Arthritis and Rheumatism Associates - Rockville ( Site 5127)Recruiting
Rockville, Maryland, United States
Kansas City Physician Partners ( Site 5119)Recruiting
Kansas City, Missouri, United States
Physician Research Collaboration, LLC ( Site 5102)Recruiting
Lincoln, Nebraska, United States
Joint and Muscle Research Institute ( Site 5108)Recruiting
Charlotte, North Carolina, United States
Altoona Center for Clinical Research ( Site 5110)Recruiting
Duncansville, Pennsylvania, United States
Hospital of the University of Pennsylvania ( Site 5134)Recruiting
Philadelphia, Pennsylvania, United States
Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)Recruiting
Summerville, South Carolina, United States
Greater Houston Rheumatology ( Site 5103)Recruiting
Houston, Texas, United States
Centre de Recherche Musculo-Squelettique ( Site 5202)Recruiting
Trois-Rivières, Quebec, Canada
Enroll SpA ( Site 8203)Recruiting
Santiago, Region M. de Santiago, Chile
Clinica Dermacross ( Site 8200)Recruiting
Santiago, Region M. de Santiago, Chile
Clinica de la Costa S.A.S. ( Site 8301)Recruiting
Barranquilla, Atlántico, Colombia
Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8306)Recruiting
Bogota, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 8302)Recruiting
Cali, Valle del Cauca Department, Colombia
Rheuma-Research Lausitz ( Site 6409)Recruiting
Cottbus, Brandenburg, Germany
Rheumazentrum Ruhrgebiet ( Site 6400)Recruiting
Herne, North Rhine-Westphalia, Germany
MICS Centrum Medyczne Bydgoszcz ( Site 6907)Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MICS Centrum Medyczne Torun ( Site 6903)Recruiting
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901)Recruiting
Lublin, Lubusz Voivodeship, Poland
MICS Centrum Medyczne Warszawa ( Site 6905)Recruiting
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 6906)Recruiting
Warsaw, Masovian Voivodeship, Poland
CHUS - Hospital Clinico Universitario ( Site 7102)Recruiting
Santiago de Compostela, La Coruna, Spain
Hospital Vall d' Hebron ( Site 7101)Recruiting
Barcelona, Spain
Hospital Viamed Santa Elena ( Site 7105)Recruiting
Madrid, Spain
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 7401)Recruiting
Kiev, Kyiv Oblast, Ukraine
Edelweiss Medics ( Site 7409)Recruiting
Kyiv, Kyivska Oblast, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 7415)Recruiting
Kyiv, Kyivska Oblast, Ukraine
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 7410)Recruiting
Lviv, Lviv Oblast, Ukraine
Limited liability company "Medical center Health Clinic" ( Site 7412)Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 7400)Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 7406)Recruiting
Kyiv, Ukraine
Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015) · TrialPath