A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
NCT ID: NCT06671496
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-03-10
2028-01-26
Brief Summary
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The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.
The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Zasocitinib
Zasocitinib tablets.
Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Zasocitinib
Zasocitinib tablets.
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.
Zasocitinib
Zasocitinib tablets.
Placebo
Zasocitinib matching placebo.
Interventions
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Zasocitinib
Zasocitinib tablets.
Placebo
Zasocitinib matching placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
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), OR
3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Tucson, Arizona, United States
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
Covina, California, United States
Direct Helpers Medical Center
Hialeah, Florida, United States
IRIS Research and Development | Plantation, FL
Plantation, Florida, United States
BayCare Medical Group
St. Petersburg, Florida, United States
North Georgia Rheumatology Group PC
Lawrenceville, Georgia, United States
Clinic of Robert Hozman
Skokie, Illinois, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Advanced Rheumatology PC | Lansing, MI
Lansing, Michigan, United States
AARR- Kansas City Physician Partners
Kansas City, Missouri, United States
DJL Clinical Research | Charlotte, NC
Charlotte, North Carolina, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
Cleveland, Ohio, United States
Altoona Center for Clinical Research | Ducansville, PA
Duncansville, Pennsylvania, United States
AARR- Lone Star Arthritis & Rheumatology Associates
Fort Worth, Texas, United States
Biopharma Informatic | Hassan
Houston, Texas, United States
Advanced Rheumatology of Houston - The Woodlands
The Woodlands, Texas, United States
Swedish Rheumatology Research
Seattle, Washington, United States
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, Argentina
Clinica Regional del Sud S.A.
Río Cuarto, Córdoba Province, Argentina
Centro de Investigaciones Reumatologicas
San Miguel de Tucumán, Tucumán Province, Argentina
CIMER
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital General de Agudo Jose Maria Ramos Mejia
Buenos Aires, , Argentina
APRILLUS Asistencia e Investigacion Clinica
Buenos Aires, , Argentina
Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina
Córdoba, , Argentina
CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Private Hospital | Clinical Trials
Sippy Downs, Queensland, Australia
The Queen Elizabeth Hospital | Rheumatology Department
Woodville South, South Australia, Australia
Fiona Stanley Hospital
Palmyra Dc, Western Australia, Australia
Colin Bayliss Research and Teaching Unit
Victoria Park, Western Australia, Australia
CMIP-Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Minas Gerais, Brazil
Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
Uberlândia, Minas Gerais, Brazil
EDUMED - Educacao em Saude SS Ltda
Curitiba, Paraná, Brazil
LMK Servicos Medicos Sociedade Simples
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department
São José do Rio Preto, São Paulo, Brazil
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, , Brazil
Niagara Rheumatology Research Centre | Ontario, Canada
Niagara Falls, Ontario, Canada
University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases
Toronto, Ontario, Canada
G.R.M.O. Inc.
Québec, Quebec, Canada
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, Anhui, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guandong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, China
Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital
Baotou Shi, Inner Mongolia, China
The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)
Hangzhou, Jiangsu, China
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiujiang No.1 People's Hospital
Jiujiang Shi, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Pingxiang, China
The 2nd Hospital of Xi'An Jiaotong University
Xi'an, Shan'xi, China
Linyi People's Hospital
Linyi Shi, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Pudong New District, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, , China
Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)
Guangzhou, , China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, , China
Wenzhou Medical University (WMU) - The First Affiliated Hospital
Wenzhou, , China
Clinique de l'Infirmerie Protestante
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
CHU Toulouse
Toulouse, Haute Garonne, France
CHRU de Tours
Tours, Indre Et Loire, France
CHU de Reims
Reims, Marne, France
Hopital Nord
Saint-Etienne, , France
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Private Practice - Dr. Maren Sieburg
Magdeburg, Saxony-Anhalt, Germany
ISA - Interdisciplinary Study Association
Berlin, , Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Kojunkai Social Medical Corporation Daido Clinic
Minami-ku, Nagoya-shi, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Fukuoka University Hospital
Fukuoka, Hukuoka, Japan
Kita-Harima Medical Center
Ono-shi, Hyōgo, Japan
Mie University Hospital
Tsu, Mie, Mie-ken, Japan
National University Corporation Tohoku University Tohoku University Hospital
Sendai, Miyagi, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, Japan
Sasebo Chuo Hospital
Sasebo-shi, Nagasaki, Japan
Nippon Life Hospital
Nishi Ward, Osaka, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo-To, Japan
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland
Krakow, Lesser Poland Voivodeship, Poland
Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki
Wroclaw, Lower Silesian Voivodeship, Poland
dermMedica Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland
Częstochowa, Silesian Voivodeship, Poland
Centrum Kliniczno Badawcze | Elblag, Poland
Elblag, Warmian-Masurian Voivodeship, Poland
Medyczne Centrum Hetmańska Piotr Leszczyński
Poznan, Wielkopolska, Poland
Clinical Research Center Sp z o o Medic-R Sp K
Poznan, Wielkopolska, Poland
Klinika Reuma Park
Warsaw, Wybierz Województwo, Poland
Zespol Poradni Specjalistycznych Reumed
Lublin, , Poland
Hospital Universitario Araba - Sede Hospital Txagorritxu
Vitoria-Gasteiz, Basque Country, Spain
Hospital Universitario Marques de Valdecilla | Rheumatology Department
Santander, Cantabria, Spain
Accellacare Alcobendas
Alcobendas, Madrid, Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Quirónsalud Sagrado Corazón
Seville, , Spain
King's College Hospital
London, Greater London, United Kingdom
Coventry and Warwickshire Partnership NHS Trust
Coventry, West Midlands, United Kingdom
St Luke's Hospital - UK
Bradford, West Yorkshire, United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Haywood Hospital
Stoke-on-Trent, , United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Related Links
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Other Identifiers
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2024-513112-99-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2031250061
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-279-PsA-3002
Identifier Type: -
Identifier Source: org_study_id
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