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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06671483

Registry updated: 2026-10-14
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Description

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.

Interventions

  • Zasocitinib (Drug)
    Zasocitinib over-encapsulated tablets.
  • Active Comparator (Drug)
    Active comparator capsule.
  • Placebo (Drug)
    Zasocitinib or active comparator matching placebo.

Eligibility criteria

Inclusion Criteria: Age: 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age. Disease Characteristics: 2. The participant has a diagnosis of PsA. 3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening. 4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria). 5. The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits. 6. The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO. Medications for PsA: 7. The participant has had at least one of the following: 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD). Exclusion Criteria: PsA and PsO: 1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia. 2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).

Conditions

Psoriatic Arthritis

Locations

  • AARR- Chandler AZ — Chandler, Arizona, United States
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States
  • First OC Dermatology Research Inc. — Fountain Valley, California, United States
  • Purushotham & Akther Kotha MD — La Mesa, California, United States
  • Triwest Research Associates LLC — La Mesa, California, United States
  • The Cohen Medical Centers — Thousand Oaks, California, United States
  • Foothill Arthritis Clinic — Tujunga, California, United States
  • Medvin Clinical Research — Whittier, California, United States
  • Denver Arthritis Clinic | Denver, CO — Denver, Colorado, United States
  • Arthritis & Rheumatic Disease Specialties (AARDS) — Aventura, Florida, United States
  • RASF- Clinical Research Center — Boca Raton, Florida, United States
  • Clinical Research of West Florida | Clearwater, FL — Clearwater, Florida, United States
  • GNP Research, LLC | Hollywood, FL — Cooper City, Florida, United States
  • Driven Research LLC — Coral Gables, Florida, United States
  • Tectum Medical Research — Davie, Florida, United States
  • Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research — Hialeah, Florida, United States
  • Bioresearch Partners — Miami, Florida, United States
  • HMD Research LLC — Orlando, Florida, United States
  • Millennium Research | Ormond Beach, FL — Ormond Beach, Florida, United States
  • IRIS Research and Development | Plantation, FL — Plantation, Florida, United States
  • Sarasota Arthritis Research Center — Sarasota, Florida, United States
  • West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
  • Clinical Research of West Florida | Tampa, FL — Tampa, Florida, United States
  • Marietta Rheumatology Associates — Marietta, Georgia, United States
  • GSCP/CIS — Orland Park, Illinois, United States
  • Greater Chicago Specialty Physicians LLC/CIS — Schaumburg, Illinois, United States
  • Accurate Clinical Research, Inc. | Lake Charles — Lake Charles, Louisiana, United States
  • Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States
  • Henry Ford Health System-Rheumatology Department — Detroit, Michigan, United States
  • Michigan Rheumatology Group, P.C. - Grand Blanc Office — Grand Blanc, Michigan, United States
  • Ash Research Clinic - Howell — Howell, Michigan, United States
  • June DO, PC Private Practice - Dr. Justus Fiechtner — Lansing, Michigan, United States
  • Clinical Research Institute of Michigan — Saint Clair Shores, Michigan, United States
  • Saint Louis Rheumatology — St Louis, Missouri, United States
  • Albuquerque Center for Rheumatology PC — Albuquerque, New Mexico, United States
  • Santa Fe Rheumatology — Santa Fe, New Mexico, United States
  • NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department — Brooklyn, New York, United States
  • Accellacare of Hickory — Hickory, North Carolina, United States
  • University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division — Cleveland, Ohio, United States
  • Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States
  • PA Regional Center for Arthritis and Osteoporosis Research — Wyomissing, Pennsylvania, United States
  • West Tennessee Research Institute — Jackson, Tennessee, United States
  • Accurate Clinical Research — Baytown, Texas, United States
  • Novel Research | Bellaire Location — Bellaire, Texas, United States
  • Novel Research | Bellaire Location — Bellaire, Texas, United States
  • Accurate Clinical Research — Houston, Texas, United States
  • Introscience Research | Northwest Houston Arthritis Center - Houston, TX — Houston, Texas, United States
  • West Texas Clinical Research — Lubbock, Texas, United States
  • Southwest Rheumatology Research, LLC | Mesquite, TX — Mesquite, Texas, United States
  • Clinical Investigations of Texas — Plano, Texas, United States
  • Arthritis Northwest, PLLC | Spokane, WA — Spokane, Washington, United States
  • Université Libre de Bruxelles — Anderlecht, Brussels Capital, Belgium
  • University Hospital Ghent — Ghent, Flanders, Belgium
  • ReumaClinic Genk — Genk, Limburg, Belgium
  • St Pierre Brussels — Brussels, Belgium
  • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman — Liège, Belgium
  • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD — Sofia, Sofia-Grad, Bulgaria
  • Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia — Sofia, Sofia-Grad, Bulgaria
  • Centre of Rheumatology St. Irina — Sofia, Sofia-Grad, Bulgaria
  • Medical Center Medconsult Pleven OOD — Pleven, Bulgaria
  • AES Partner Site -Plovdiv — Plovdiv, Bulgaria
  • Medical Center Artmed OOD | Plovdiv, Bulgaria — Plovdiv, Bulgaria
  • Diagnostic- Consultative Center- 1- Ruse EOOD — Rousse, Bulgaria
  • Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria — Stara Zagora, Bulgaria
  • Medical Center Zara-Med EOOD — Stara Zagora, Bulgaria
  • El Centro de Estudios Reumatologicos (CER) — Providencia, Santiago Metropolitan, Chile
  • Clinica Dermacross S.A. — Santiago, Santiago Metropolitan, Chile
  • Centro de Estudios Clinicos — Santiago, Chile
  • CTR Estudios — Santiago, Chile
  • Centro Internacional de Estudios Clínicos — Santiago, Chile
  • Medicinski Centar Kuna and Peric — Zagreb, City of Zagreb, Croatia
  • Clinical Hospital Centre Osijek — Osijek, Croatia
  • Clinical Hospital Center Rijeka — Rijeka, Croatia
  • University Hospital Centre Split — Split, Croatia
  • General Hospital Zadar — Zadar, Croatia
  • Revmatologie s.r.o. | Brno, Czech Republic — Brno, Czech Rep, Czechia
  • L.K.N. Arthrocentrum, s.r.o. - Revmatologicka — Hlučín, Czech Rep, Czechia
  • Clintrial s.r.o. | Prague, Czech Republic — Prague, Czech Rep, Czechia
  • Praglandia | Prague, Czech Republic — Prague, Czech Rep, Czechia
  • MEDICAL Plus s.r.o. — Uherské Hradiště, Czech Rep, Czechia
  • CCR Ostrava — Ostrava, Moravian-Silesian Region, Czechia
  • Pv Medical Services — Zlín, NAP, Czechia
  • Revmatologicky ustav | Clinical Evaluation Department — Prague, Prague, Czechia
  • Pratia Pardubice a.s. — Pardubice, Czechia
  • Innomedica OU | Tallinn, Estonia — Tallinn, Harju, Estonia
  • Center for Clinical and Basic Research — Tallinn, Harju, Estonia
  • Clinical Research Centre | Tartu, Estonia — Tartu, Tartu, Estonia
  • North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department — Tallinn, Estonia
  • MediTrials OÜ — Tartu, Estonia
  • Fachklinik Bad Bentheim — Bad Bentheim, Lower Saxony, Germany
  • Rheumzentrum Prof.Dr.med.Gunther Neeck — Bad Doberan, Mecklenburg-Vorpommern, Germany
  • Rheumazentrum Ratingen-Studienambulanz — Ratingen, North Rhine-Westphalia, Germany
  • Universitaetsklinikum Leipzig AoeR — Leipzig, Saxony, Germany
  • Rheumatologische Schwerpunktpraxis | Berlin, Germany — Berlin, Germany
  • Städtisches Klinikum Dresden — Dresden, Germany
  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg — Hamburg, Germany
  • Medicover MVZ München Ost — München, Germany
  • Porcika Klinika — Hódmezővásárhely, Csongrad-Csanad, Hungary
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Csongrad-Csanad, Hungary
  • CMed Rehabilitacios es Diagnosztikai Kozpont — Székesfehérvár, Fejér, Hungary
  • Qualiclinic | Budapest, Hungary — Budapest, Hungary
  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center — Székesfehérvár, Hungary
  • Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary — Veszprém, Hungary
  • Assuta Ashdod Medical Center — Ashdod, Southern District, Israel
  • Barzilai Medical Center | Rheumatology Department — Ashkelon, Israel
  • Rambam Health Care Campus — Haifa, Israel
  • Galilee Medical Center | Rheumatology Unit — Nahariya, Israel
  • The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases — Ramat Gan, Israel
  • Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
  • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica — Torrette, Ancona, Italy
  • Fondazione PTV Policlinico Tor Vergata — Rome, Lazio, Italy
  • Policlinico Agostino Gemelli, UOC Reumatology — Rome, Lazio, Italy
  • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO — Milan, Lombardy, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele — Milan, Lombardy, Italy
  • IRCCS Istituto Clinico Humanitas — Rozzano, Milano, Italy
  • Azienda Ospedale Università Padova — Padova, Veneto, Italy
  • Azienda Ospedaliera Universitaria Careggi — Florence, Italy
  • Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
  • D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia — Liepāja, Latvia
  • ORTO Clinic | Rheumatology Department — Riga, Latvia
  • Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO) — Mexicali, Estado de Baja California, Mexico
  • iBiomed Guadalajara — Zapopan, Guadalajara, Mexico
  • Centro Integral en Reumatologia, S.A. de C.V. — Guadalajara, Jalisco, Mexico
  • Private Practice - Dr. Delfina Villanueva Quintero — Guadalajara, Jalisco, Mexico
  • Consultorio de Reumatologia — Gustavo Adolfo Madero, Mexico City, Mexico
  • HMG Hospital Coyoacan — Mexico City, Mexico City, Mexico
  • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. — Mexico City, Mexico City, Mexico
  • Kohler and Milstein Research Yucatan — Mérida, Yucatán, Mexico
  • Hospitales Star Medica — Mérida, Yucatán, Mexico
  • Office of Cesar F. Pacheco-Tena, MD — Chihuahua City, Mexico
  • CGM Research Trust — Christchurch Central, Christchurch, New Zealand
  • Aotearoa Clinical Trials — Auckland, North Island, New Zealand
  • North Shore Hospital — Auckland, North Island, New Zealand
  • Porter Rheumatology Ltd — Nelson, South Island, New Zealand
  • Waikato Hospital — Hamilton, Waikato Region, New Zealand
  • Pratia Poznań — Poznan, Greater Poland Voivodeship, Poland
  • Centrum Medyczne Plejady — Krakow, Lesser Poland Voivodeship, Poland
  • Pratia MCM Krakow — Krakow, Lesser Poland Voivodeship, Poland
  • Krakowskie Centrum Medyczne — Krakow, Lesser Poland Voivodeship, Poland
  • Centrum Medyczne Katowice - PRATIA — Katowice, Lower Silesian Voivodeship, Poland
  • RCMed | Sochaczew, Poland — Sochaczew, Masovian Voivodeship, Poland
  • Rheuma Medicus | Warsaw, Poland — Warsaw, Masovian Voivodeship, Poland
  • MTZ Clinical Research Powered by PRATIA — Warsaw, Masovian Voivodeship, Poland
  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic — Warsaw, Masovian Voivodeship, Poland
  • Centrum Medyczne Reuma Park — Warsaw, Masovian Voivodeship, Poland
  • ETG Warszawa Sp. z o.o. — Warsaw, Masovian Voivodeship, Poland
  • Twoja Przychodnia Opolskie Centrum Medyczne — Opole, Opole Voivodeship, Poland
  • INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland — Bialystok, Podlaskie Voivodeship, Poland
  • Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty — Bialystok, Podlaskie Voivodeship, Poland
  • Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik — Bialystok, Podlaskie Voivodeship, Poland
  • Bif-Med s.c. NZOZ — Bytom, Silesian Voivodeship, Poland
  • MICS Centrum Medyczne Torun — Torun, Silesian Voivodeship, Poland
  • UNICA CR sp. z.o. o. — Dąbrówka, Warmian-Masurian Voivodeship, Poland
  • Ambulatorium Sp. z o.o. — Elblag, Warmian-Masurian Voivodeship, Poland
  • Etyka Osrodek Badan Klinicznych | Olsztyn, Poland — Olsztyn, Warmian-Masurian Voivodeship, Poland
  • Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o. — Poznan, Wielkopolska, Poland
  • Reumedika | Poznan, Poland — Poznan, Wlkp, Poland
  • Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland — Poznan, Woj. Wielkopolskie, Poland
  • Santa Familia PTG Lodz | Lodz, Poland — Lodz, Poland
  • FutureMeds | Lodz Center - Lodz, Poland — Lodz, Poland
  • Twoja Przychodnia | Nowa Sol, Poland — Nowa Sól, Poland
  • FutureMeds Wroclaw — Wroclaw, Poland
  • Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra — Coimbra, Barcelona, Portugal
  • Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho — Ponte de Lima, Barcelona, Portugal
  • Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E — Vila Nova de Gaia, New Mexico, Portugal
  • Hospital Garcia de Orta — Almada, Portugal
  • Instituto Portugues de Reumatologia — Lisbon, Portugal
  • Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department — Lisbon, Portugal
  • Centro Reumatologico de Caguas | Caguas, PR — Caguas, Puerto Rico
  • GCM Medical Group, PSC | San Juan, PR — San Juan, Puerto Rico
  • The Catholic University of Korea — Suwon, Gyeonggi-do, South Korea
  • Ajou University Hospital | Clinical Trial Center — Suwon, Gyeonggido, South Korea
  • Asan Medical Center — Seoul, South Korea
  • SMG - SNU Boramae Medical Center — Seoul, South Korea
  • Kyung Hee University Hospital — Seoul, South Korea
  • Hospital Universitario de Badajoz — Mérida, Badajoz, Spain
  • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell — Sabadell, Barcelona, Spain
  • Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department — Santiago de Compostela, Galicia, Spain
  • Hospital Regional Universitario de Malaga — Málaga, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • National Cheng Kung University — Tainan, Tainan City, Taiwan
  • National Taiwan University Hospital — Zhong Zheng Qu, Taipei City, Taiwan
  • Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department — New Taipei City, Taiwan
  • Chung Shan Medical University Hospital — Taichung, Taiwan
  • Chi Mei Medical Center — Tainan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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