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

NCT06671483 · Takeda
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Official title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
About this study
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.
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).
Study design
Enrollment target: 1088 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-03
Estimated completion: 2028-01-28
Last updated: 2026-04-06
Interventions
Drug: ZasocitinibDrug: Active ComparatorDrug: Placebo
Primary outcomes
  • Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo (At Week 16)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (189)
AARR- Chandler AZRecruiting
Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Phoenix, Arizona, United States
First OC Dermatology Research Inc.Recruiting
Fountain Valley, California, United States
Purushotham & Akther Kotha MDRecruiting
La Mesa, California, United States
Triwest Research Associates LLCRecruiting
La Mesa, California, United States
The Cohen Medical CentersRecruiting
Thousand Oaks, California, United States
Foothill Arthritis ClinicRecruiting
Tujunga, California, United States
Medvin Clinical ResearchRecruiting
Whittier, California, United States
Denver Arthritis Clinic | Denver, CORecruiting
Denver, Colorado, United States
Arthritis & Rheumatic Disease Specialties (AARDS)Recruiting
Aventura, Florida, United States
RASF- Clinical Research CenterRecruiting
Boca Raton, Florida, United States
Clinical Research of West Florida | Clearwater, FLRecruiting
Clearwater, Florida, United States
GNP Research, LLC | Hollywood, FLRecruiting
Cooper City, Florida, United States
Driven Research LLCRecruiting
Coral Gables, Florida, United States
Tectum Medical ResearchRecruiting
Davie, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical ResearchRecruiting
Hialeah, Florida, United States
Bioresearch PartnersRecruiting
Miami, Florida, United States
HMD Research LLCRecruiting
Orlando, Florida, United States
Millennium Research | Ormond Beach, FLRecruiting
Ormond Beach, Florida, United States
IRIS Research and Development | Plantation, FLRecruiting
Plantation, Florida, United States
Sarasota Arthritis Research CenterRecruiting
Sarasota, Florida, United States
West Broward Rheumatology Associates, Inc.Recruiting
Tamarac, Florida, United States
Clinical Research of West Florida | Tampa, FLRecruiting
Tampa, Florida, United States
Marietta Rheumatology AssociatesRecruiting
Marietta, Georgia, United States
GSCP/CISRecruiting
Orland Park, Illinois, United States
Greater Chicago Specialty Physicians LLC/CISRecruiting
Schaumburg, Illinois, United States
Accurate Clinical Research, Inc. | Lake CharlesRecruiting
Lake Charles, Louisiana, United States
Klein & Associates, M.D., P.A.Recruiting
Hagerstown, Maryland, United States
Henry Ford Health System-Rheumatology DepartmentNot Yet Recruiting
Detroit, Michigan, United States
Michigan Rheumatology Group, P.C. - Grand Blanc OfficeRecruiting
Grand Blanc, Michigan, United States
Ash Research Clinic - HowellRecruiting
Howell, Michigan, United States
June DO, PC Private Practice - Dr. Justus FiechtnerRecruiting
Lansing, Michigan, United States
Clinical Research Institute of MichiganRecruiting
Saint Clair Shores, Michigan, United States
Saint Louis RheumatologyRecruiting
St Louis, Missouri, United States
Albuquerque Center for Rheumatology PCRecruiting
Albuquerque, New Mexico, United States
Santa Fe RheumatologyRecruiting
Santa Fe, New Mexico, United States
NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology DepartmentRecruiting
Brooklyn, New York, United States
Accellacare of HickoryRecruiting
Hickory, North Carolina, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology DivisionRecruiting
Cleveland, Ohio, United States
Paramount Medical Research & Consulting, LLCRecruiting
Middleburg Heights, Ohio, United States
PA Regional Center for Arthritis and Osteoporosis ResearchRecruiting
Wyomissing, Pennsylvania, United States
West Tennessee Research InstituteRecruiting
Jackson, Tennessee, United States
Accurate Clinical ResearchRecruiting
Baytown, Texas, United States
Novel Research | Bellaire LocationRecruiting
Houston, Texas, United States
Novel Research | Bellaire LocationRecruiting
Houston, Texas, United States
Accurate Clinical ResearchRecruiting
Houston, Texas, United States
Introscience Research | Northwest Houston Arthritis Center - Houston, TXRecruiting
Houston, Texas, United States
West Texas Clinical ResearchRecruiting
Lubbock, Texas, United States
Southwest Rheumatology Research, LLC | Mesquite, TXRecruiting
Mesquite, Texas, United States
Clinical Investigations of TexasRecruiting
Plano, Texas, United States
Arthritis Northwest, PLLC | Spokane, WARecruiting
Spokane, Washington, United States
Medical College of Wisconsin | Department of Medicine - Rheumatology DivisionNot Yet Recruiting
Milwaukee, Wisconsin, United States
Université Libre de BruxellesRecruiting
Anderlecht, Brussels Capital, Belgium
University Hospital GhentRecruiting
Ghent, Flanders, Belgium
ReumaClinic GenkRecruiting
Genk, Limburg, Belgium
St Pierre BrusselsRecruiting
Brussels, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
Diagnostic Consultative Centre - Focus-5 - LZIP EOODRecruiting
Sofia, Sofia-Grad, Bulgaria
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - SofiaRecruiting
Sofia, Sofia-Grad, Bulgaria
Centre of Rheumatology St. IrinaRecruiting
Sofia, Sofia-Grad, Bulgaria
Medical Center Medconsult Pleven OODRecruiting
Pleven, Bulgaria
AES Partner Site -PlovdivRecruiting
Plovdiv, Bulgaria
Medical Center Artmed OOD | Plovdiv, BulgariaRecruiting
Plovdiv, Bulgaria
Diagnostic- Consultative Center- 1- Ruse EOODRecruiting
Rousse, Bulgaria
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, BulgariaRecruiting
Stara Zagora, Bulgaria
Medical Center Zara-Med EOODRecruiting
Stara Zagora, Bulgaria
El Centro de Estudios Reumatologicos (CER)Recruiting
Providencia, Santiago Metropolitan, Chile
Clinica Dermacross S.A.Recruiting
Santiago, Santiago Metropolitan, Chile
Centro de Estudios ClinicosRecruiting
Santiago, Chile
CTR EstudiosRecruiting
Santiago, Chile
Centro Internacional de Estudios ClínicosRecruiting
Santiago, Chile
Medicinski Centar Kuna and PericRecruiting
Zagreb, City of Zagreb, Croatia
Clinical Hospital Centre OsijekRecruiting
Osijek, Croatia
Clinical Hospital Center RijekaRecruiting
Rijeka, Croatia
University Hospital Centre SplitRecruiting
Split, Croatia
General Hospital ZadarRecruiting
Zadar, Croatia
Revmatologie s.r.o. | Brno, Czech RepublicRecruiting
Brno, Czech Rep, Czechia
L.K.N. Arthrocentrum, s.r.o. - RevmatologickaRecruiting
Hlučín, Czech Rep, Czechia
Clintrial s.r.o. | Prague, Czech RepublicRecruiting
Prague, Czech Rep, Czechia
Praglandia | Prague, Czech RepublicRecruiting
Prague, Czech Rep, Czechia
MEDICAL Plus s.r.o.Recruiting
Uherské Hradiště, Czech Rep, Czechia
CCR OstravaRecruiting
Ostrava, Moravian-Silesian Region, Czechia
Pv Medical ServicesRecruiting
Zlín, NAP, Czechia
Revmatologicky ustav | Clinical Evaluation DepartmentNot Yet Recruiting
Prague, Prague, Czechia
Pratia Pardubice a.s.Recruiting
Pardubice, Czechia
Innomedica OU | Tallinn, EstoniaRecruiting
Tallinn, Harju, Estonia
Center for Clinical and Basic ResearchRecruiting
Tallinn, Harju, Estonia
Clinical Research Centre | Tartu, EstoniaRecruiting
Tartu, Tartu, Estonia
North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology DepartmentRecruiting
Tallinn, Estonia
MediTrials OÜRecruiting
Tartu, Estonia
Fachklinik Bad BentheimRecruiting
Bad Bentheim, Lower Saxony, Germany
Rheumzentrum Prof.Dr.med.Gunther NeeckRecruiting
Bad Doberan, Mecklenburg-Vorpommern, Germany
Rheumazentrum Ratingen-StudienambulanzRecruiting
Ratingen, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeRRecruiting
Leipzig, Saxony, Germany
Rheumatologische Schwerpunktpraxis | Berlin, GermanyRecruiting
Berlin, Germany
Städtisches Klinikum DresdenRecruiting
Dresden, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - HamburgRecruiting
Hamburg, Germany
Medicover MVZ München OstRecruiting
München, Germany
Porcika KlinikaRecruiting
Hódmezővásárhely, Csongrad-Csanad, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
Szeged, Csongrad-Csanad, Hungary
CMed Rehabilitacios es Diagnosztikai KozpontRecruiting
Székesfehérvár, Fejér, Hungary
Qualiclinic | Budapest, HungaryRecruiting
Budapest, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis CenterRecruiting
Székesfehérvár, Hungary
Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, HungaryRecruiting
Veszprém, Hungary
Assuta Ashdod Medical CenterRecruiting
Ashdod, Southern District, Israel
Barzilai Medical Center | Rheumatology DepartmentRecruiting
Ashkelon, Israel
Rambam Health Care CampusRecruiting
Haifa, Israel
Galilee Medical Center | Rheumatology UnitRecruiting
Nahariya, Israel
The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune DiseasesRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica MedicaRecruiting
Torrette, Ancona, Italy
Fondazione PTV Policlinico Tor VergataNot Yet Recruiting
Rome, Lazio, Italy
Policlinico Agostino Gemelli, UOC ReumatologyRecruiting
Rome, Lazio, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTORecruiting
Milan, Lombardy, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
IRCCS Istituto Clinico HumanitasRecruiting
Rozzano, Milano, Italy
Azienda Ospedale Università PadovaRecruiting
Padova, Veneto, Italy
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Italy
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, LatviaRecruiting
Liepāja, Latvia
ORTO Clinic | Rheumatology DepartmentRecruiting
Riga, Latvia
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)Recruiting
Mexicali, Estado de Baja California, Mexico
iBiomed GuadalajaraRecruiting
Zapopan, Guadalajara, Mexico
Centro Integral en Reumatologia, S.A. de C.V.Recruiting
Guadalajara, Jalisco, Mexico
Private Practice - Dr. Delfina Villanueva QuinteroRecruiting
Guadalajara, Jalisco, Mexico
Consultorio de ReumatologiaRecruiting
Gustavo Adolfo Madero, Mexico City, Mexico
HMG Hospital CoyoacanNot Yet Recruiting
Mexico City, Mexico City, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.Recruiting
Mexico City, Mexico City, Mexico
Kohler and Milstein Research YucatanRecruiting
Mérida, Yucatán, Mexico
Hospitales Star MedicaRecruiting
Mérida, Yucatán, Mexico
Office of Cesar F. Pacheco-Tena, MDRecruiting
Chihuahua City, Mexico
CGM Research TrustRecruiting
Christchurch Central, Christchurch, New Zealand
Aotearoa Clinical TrialsRecruiting
Auckland, North Island, New Zealand
North Shore HospitalRecruiting
Auckland, North Island, New Zealand
Porter Rheumatology LtdRecruiting
Nelson, South Island, New Zealand
Waikato HospitalRecruiting
Hamilton, Waikato Region, New Zealand
Pratia PoznańRecruiting
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne PlejadyRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Pratia MCM KrakowRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Krakowskie Centrum MedyczneRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Katowice - PRATIARecruiting
Katowice, Lower Silesian Voivodeship, Poland
RCMed | Sochaczew, PolandRecruiting
Sochaczew, Masovian Voivodeship, Poland
Rheuma Medicus | Warsaw, PolandRecruiting
Warsaw, Masovian Voivodeship, Poland
MTZ Clinical Research Powered by PRATIARecruiting
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań KlinicRecruiting
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Masovian Voivodeship, Poland
ETG Warszawa Sp. z o.o.Recruiting
Warsaw, Masovian Voivodeship, Poland
Twoja Przychodnia Opolskie Centrum MedyczneRecruiting
Opole, Opole Voivodeship, Poland
INTER CLINIC Piotr Adrian Klimiuk | Bialystok, PolandRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i FizjoterapeutyRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J SupronikRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Bif-Med s.c. NZOZRecruiting
Bytom, Silesian Voivodeship, Poland
MICS Centrum Medyczne TorunRecruiting
Torun, Silesian Voivodeship, Poland
UNICA CR sp. z.o. o.Recruiting
Dąbrówka, Warmian-Masurian Voivodeship, Poland
Ambulatorium Sp. z o.o.Recruiting
Elblag, Warmian-Masurian Voivodeship, Poland
Etyka Osrodek Badan Klinicznych | Olsztyn, PolandRecruiting
Olsztyn, Warmian-Masurian Voivodeship, Poland
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.Recruiting
Poznan, Wielkopolska, Poland
Reumedika | Poznan, PolandRecruiting
Poznan, Wlkp, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, PolandRecruiting
Poznan, Woj. Wielkopolskie, Poland
Santa Familia PTG Lodz | Lodz, PolandRecruiting
Lodz, Poland
FutureMeds | Lodz Center - Lodz, PolandRecruiting
Lodz, Poland
Twoja Przychodnia | Nowa Sol, PolandRecruiting
Nowa Sól, Poland
FutureMeds WroclawRecruiting
Wroclaw, Poland
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de CoimbraRecruiting
Coimbra, Barcelona, Portugal
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto MinhoRecruiting
Ponte de Lima, Barcelona, Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.ERecruiting
Vila Nova de Gaia, New Mexico, Portugal
Hospital Garcia de OrtaRecruiting
Almada, Portugal
Instituto Portugues de ReumatologiaRecruiting
Lisbon, Portugal
Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology DepartmentRecruiting
Lisbon, Portugal
Centro Reumatologico de Caguas | Caguas, PRRecruiting
Caguas, Puerto Rico
GCM Medical Group, PSC | San Juan, PRRecruiting
San Juan, Puerto Rico
The Catholic University of KoreaRecruiting
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital | Clinical Trial CenterRecruiting
Suwon, Gyeonggido, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
SMG - SNU Boramae Medical CenterRecruiting
Seoul, South Korea
Kyung Hee University HospitalRecruiting
Seoul, South Korea
Hospital Universitario de BadajozRecruiting
Mérida, Badajoz, Spain
Corporacio Sanitaria Parc Tauli - Hospital de SabadellRecruiting
Sabadell, Barcelona, Spain
Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology DepartmentRecruiting
Santiago de Compostela, Galicia, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
National Cheng Kung UniversityRecruiting
Tainan, Tainan City, Taiwan
National Taiwan University HospitalRecruiting
Zhong Zheng Qu, Taipei City, Taiwan
Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology DepartmentRecruiting
New Taipei City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
Chi Mei Medical CenterRecruiting
Tainan, Taiwan
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines · TrialPath