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)

Status: Recruiting
Location: See all (189) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Age:

• 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:

• The participant has a diagnosis of PsA.

• The participant must have signs and symptoms of PsA for at least 3 months prior to screening.

• The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).

• 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.

• 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:

• The participant has had at least one of the following:

‣ Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR

⁃ Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).

Locations
United States
Arizona
AARR- Chandler AZ
RECRUITING
Chandler
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Phoenix
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Phoenix
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Phoenix
California
First OC Dermatology Research Inc.
RECRUITING
Fountain Valley
Purushotham & Akther Kotha MD
RECRUITING
La Mesa
Triwest Research Associates LLC
RECRUITING
La Mesa
VA Northern California Health Care System - NAVREF - PPDS
NOT_YET_RECRUITING
Mather
Biosolutions Research Center | La Mesa, CA
NOT_YET_RECRUITING
Poway
The Cohen Medical Centers
RECRUITING
Thousand Oaks
Foothill Arthritis Clinic
RECRUITING
Tujunga
Medvin Clinical Research
RECRUITING
Whittier
Colorado
Denver Arthritis Clinic | Denver, CO
RECRUITING
Denver
Florida
Arthritis & Rheumatic Disease Specialties (AARDS)
RECRUITING
Aventura
RASF- Clinical Research Center
RECRUITING
Boca Raton
Clinical Research of West Florida | Clearwater, FL
RECRUITING
Clearwater
GNP Research, LLC | Hollywood, FL
RECRUITING
Cooper City
Driven Research LLC
RECRUITING
Coral Gables
Tectum Medical Research
RECRUITING
Davie
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
RECRUITING
Hialeah
Bioresearch Partners
RECRUITING
Miami
HMD Research LLC
RECRUITING
Orlando
Millennium Research | Ormond Beach, FL
RECRUITING
Ormond Beach
IRIS Research and Development | Plantation, FL
RECRUITING
Plantation
Sarasota Arthritis Research Center
NOT_YET_RECRUITING
Sarasota
West Broward Rheumatology Associates, Inc.
RECRUITING
Tamarac
Clinical Research of West Florida | Tampa, FL
RECRUITING
Tampa
Georgia
Marietta Rheumatology Associates
RECRUITING
Marietta
Illinois
GSCP/CIS
RECRUITING
Orland Park
Greater Chicago Specialty Physicians LLC/CIS
RECRUITING
Schaumburg
Louisiana
Accurate Clinical Research, Inc. | Lake Charles
RECRUITING
Lake Charles
Maryland
Klein & Associates, M.D., P.A.
RECRUITING
Hagerstown
Michigan
Henry Ford Health System-Rheumatology Department
NOT_YET_RECRUITING
Detroit
Michigan Rheumatology Group, P.C. - Grand Blanc Office
RECRUITING
Grand Blanc
Ash Research Clinic - Howell
RECRUITING
Howell
June DO, PC Private Practice - Dr. Justus Fiechtner
RECRUITING
Lansing
Clinical Research Institute of Michigan
RECRUITING
Saint Clair Shores
Missouri
Saint Louis Rheumatology
RECRUITING
St Louis
North Carolina
Accellacare of Hickory
RECRUITING
Hickory
New Mexico
Albuquerque Center for Rheumatology PC
RECRUITING
Albuquerque
Santa Fe Rheumatology
RECRUITING
Santa Fe
New York
NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department
NOT_YET_RECRUITING
Brooklyn
Ohio
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
RECRUITING
Cleveland
Paramount Medical Research & Consulting, LLC
RECRUITING
Middleburg Heights
Pennsylvania
PA Regional Center for Arthritis and Osteoporosis Research
RECRUITING
Wyomissing
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Accurate Clinical Research
RECRUITING
Baytown
Accurate Clinical Research
RECRUITING
Houston
Introscience Research | Northwest Houston Arthritis Center - Houston, TX
RECRUITING
Houston
Novel Research | Bellaire Location
RECRUITING
Houston
Novel Research | Bellaire Location
RECRUITING
Houston
West Texas Clinical Research
RECRUITING
Lubbock
Southwest Rheumatology Research, LLC | Mesquite, TX
RECRUITING
Mesquite
Clinical Investigations of Texas
RECRUITING
Plano
Washington
Arthritis Northwest, PLLC | Spokane, WA
RECRUITING
Spokane
Wisconsin
Medical College of Wisconsin | Department of Medicine - Rheumatology Division
NOT_YET_RECRUITING
Milwaukee
Other Locations
Belgium
Université Libre de Bruxelles
RECRUITING
Anderlecht
St Pierre Brussels
RECRUITING
Brussels
ReumaClinic Genk
RECRUITING
Genk
University Hospital Ghent
NOT_YET_RECRUITING
Ghent
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
RECRUITING
Liège
Bulgaria
Medical Center Medconsult Pleven OOD
RECRUITING
Pleven
AES Partner Site -Plovdiv
RECRUITING
Plovdiv
Medical Center Artmed OOD | Plovdiv, Bulgaria
RECRUITING
Plovdiv
Diagnostic- Consultative Center- 1- Ruse EOOD
RECRUITING
Rousse
Centre of Rheumatology St. Irina
RECRUITING
Sofia
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
NOT_YET_RECRUITING
Sofia
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia
NOT_YET_RECRUITING
Sofia
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria
RECRUITING
Stara Zagora
Medical Center Zara-Med EOOD
RECRUITING
Stara Zagora
Chile
El Centro de Estudios Reumatologicos (CER)
RECRUITING
Providencia
Centro de Estudios Clinicos
RECRUITING
Santiago
Centro Internacional de Estudios Clínicos
RECRUITING
Santiago
Clinica Dermacross S.A.
RECRUITING
Santiago
CTR Estudios
RECRUITING
Santiago
Colombia
Centro Integral de Reumatologia Circaribe S.A.S.
NOT_YET_RECRUITING
Barranquilla
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
NOT_YET_RECRUITING
Bogota D.c.
Fundacion Santa Fe de Bogota
NOT_YET_RECRUITING
Bogotá D.c.
Servimed S.A.S
NOT_YET_RECRUITING
Bucaramanga
Preventive Care S.A.S.
NOT_YET_RECRUITING
Chía
Croatia
Clinical Hospital Centre Osijek
NOT_YET_RECRUITING
Osijek
Clinical Hospital Center Rijeka
RECRUITING
Rijeka
University Hospital Centre Split
RECRUITING
Split
General Hospital Zadar
RECRUITING
Zadar
Medicinski Centar Kuna and Peric
RECRUITING
Zagreb
Estonia
Center for Clinical and Basic Research
RECRUITING
Tallinn
Innomedica OU | Tallinn, Estonia
RECRUITING
Tallinn
North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department
RECRUITING
Tallinn
Clinical Research Centre | Tartu, Estonia
RECRUITING
Tartu
MediTrials OÜ
RECRUITING
Tartu
Germany
Fachklinik Bad Bentheim
NOT_YET_RECRUITING
Bad Bentheim
Rheumzentrum Prof.Dr.med.Gunther Neeck
NOT_YET_RECRUITING
Bad Doberan
Rheumatologische Schwerpunktpraxis | Berlin, Germany
NOT_YET_RECRUITING
Berlin
Städtisches Klinikum Dresden
NOT_YET_RECRUITING
Dresden
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
NOT_YET_RECRUITING
Hamburg
Universitaetsklinikum Leipzig AoeR
NOT_YET_RECRUITING
Leipzig
Medicover MVZ München Ost
NOT_YET_RECRUITING
München
Rheumazentrum Ratingen-Studienambulanz
NOT_YET_RECRUITING
Ratingen
Hungary
Qualiclinic | Budapest, Hungary
RECRUITING
Budapest
Porcika Klinika
RECRUITING
Hódmezővásárhely
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING
Szeged
CMed Rehabilitacios es Diagnosztikai Kozpont
RECRUITING
Székesfehérvár
Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center
RECRUITING
Székesfehérvár
Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary
RECRUITING
Veszprém
Israel
Assuta Ashdod Medical Center
RECRUITING
Ashdod
Barzilai Medical Center | Rheumatology Department
RECRUITING
Ashkelon
Rambam Health Care Campus
RECRUITING
Haifa
Galilee Medical Center | Rheumatology Unit
RECRUITING
Nahariya
The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
RECRUITING
Milan
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedale Università Padova
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Fondazione PTV Policlinico Tor Vergata
NOT_YET_RECRUITING
Rome
Policlinico Agostino Gemelli, UOC Reumatology
RECRUITING
Rome
IRCCS Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
RECRUITING
Torrette
Latvia
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
RECRUITING
Liepāja
ORTO Clinic | Rheumatology Department
RECRUITING
Riga
Mexico
Office of Cesar F. Pacheco-Tena, MD
NOT_YET_RECRUITING
Chihuahua City
Centro Integral en Reumatologia, S.A. de C.V.
NOT_YET_RECRUITING
Guadalajara
Private Practice - Dr. Delfina Villanueva Quintero
NOT_YET_RECRUITING
Guadalajara
Consultorio de Reumatologia
NOT_YET_RECRUITING
Gustavo Adolfo Madero
Hospitales Star Medica
NOT_YET_RECRUITING
Mérida
Kohler and Milstein Research Yucatan
NOT_YET_RECRUITING
Mérida
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
NOT_YET_RECRUITING
Mexicali
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
RECRUITING
Mexico City
HMG Hospital Coyoacan
NOT_YET_RECRUITING
Mexico City
iBiomed Guadalajara
NOT_YET_RECRUITING
Zapopan
New Zealand
Aotearoa Clinical Trials
RECRUITING
Auckland
North Shore Hospital
NOT_YET_RECRUITING
Auckland
CGM Research Trust
RECRUITING
Christchurch Central
Waikato Hospital
RECRUITING
Hamilton
Porter Rheumatology Ltd
RECRUITING
Nelson
Poland
INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland
RECRUITING
Bialystok
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
RECRUITING
Bialystok
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
RECRUITING
Bialystok
Bif-Med s.c. NZOZ
RECRUITING
Bytom
UNICA CR sp. z.o. o.
RECRUITING
Dąbrówka
Ambulatorium Sp. z o.o.
RECRUITING
Elblag
Centrum Medyczne Katowice - PRATIA
RECRUITING
Katowice
Centrum Medyczne Plejady
RECRUITING
Krakow
Krakowskie Centrum Medyczne
RECRUITING
Krakow
Pratia MCM Krakow
RECRUITING
Krakow
FutureMeds | Lodz Center - Lodz, Poland
RECRUITING
Lodz
Santa Familia PTG Lodz | Lodz, Poland
RECRUITING
Lodz
Twoja Przychodnia | Nowa Sol, Poland
RECRUITING
Nowa Sól
Etyka Osrodek Badan Klinicznych | Olsztyn, Poland
RECRUITING
Olsztyn
Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITING
Opole
Pratia Poznań
RECRUITING
Poznan
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland
RECRUITING
Poznan
Reumedika | Poznan, Poland
RECRUITING
Poznan
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
RECRUITING
Poznan
RCMed | Sochaczew, Poland
RECRUITING
Sochaczew
MICS Centrum Medyczne Torun
RECRUITING
Torun
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
ETG Warszawa Sp. z o.o.
RECRUITING
Warsaw
MTZ Clinical Research Powered by PRATIA
RECRUITING
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic
RECRUITING
Warsaw
Rheuma Medicus | Warsaw, Poland
RECRUITING
Warsaw
FutureMeds Wroclaw
RECRUITING
Wroclaw
WroMedica Centrum Zdrowia | Rheumatology Clinic
NOT_YET_RECRUITING
Wroclaw
Portugal
Hospital Garcia de Orta
RECRUITING
Almada
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
NOT_YET_RECRUITING
Coimbra
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
NOT_YET_RECRUITING
Coimbra
Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department
RECRUITING
Lisbon
Instituto Portugues de Reumatologia
RECRUITING
Lisbon
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
RECRUITING
Ponte De Lima
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
NOT_YET_RECRUITING
Vila Nova De Gaia
Puerto Rico
Centro Reumatologico de Caguas | Caguas, PR
RECRUITING
Caguas
GCM Medical Group, PSC | San Juan, PR
RECRUITING
San Juan
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
SMG - SNU Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Ajou University Hospital | Clinical Trial Center
RECRUITING
Suwon
The Catholic University of Korea
RECRUITING
Suwon
Spain
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Universitario de Badajoz
RECRUITING
Mérida
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
RECRUITING
Sabadell
Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Taiwan
Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department
RECRUITING
New Taipei City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Chi Mei Medical Center
NOT_YET_RECRUITING
Tainan City
National Cheng Kung University
NOT_YET_RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Zhong Zheng Qu
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2028-01-28
Participants
Target number of participants: 1088
Treatments
Experimental: Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Experimental: Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Active_comparator: Active Comparator Dose C
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Experimental: Placebo + Zasoctinib
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov