A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Last updated: June 26, 2026
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Bone Diseases

Treatment

Zasocitinib

Placebo

Clinical Study ID

NCT06671496
TAK-279-PsA-3002
2024-513112-99-00
jRCT2031250061
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age:

  1. The participant is aged 18 years or older at the time of signing the informedconsent 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 toscreening.

  4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPARcriteria).

  5. The participant has active arthritis as shown by a minimum of >=3 tender joints inTJC68 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, orany nail or nail bed changes characteristic of PsO. Medications for PsA:

  7. The participant has had at least one of the following:

  8. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (notapplicable in the European Union [EU]/ European Economic Area [EEA]), OR

  9. Inadequate response to a conventional synthetic disease-modifying antirheumaticdrug (csDMARD), OR

  10. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

Exclusion

Exclusion Criteria:

PsA and PsO:

  1. The participant has other disease(s) that might confound the evaluations of benefitof zasocitinib therapy, including but not limited to rheumatoid arthritis, axialspondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, orfibromyalgia.

  2. The participant has a concomitant comorbid skin condition that, in the opinion ofthe investigator, would interfere with the study assessments, such as evidence ofnon-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, ordrug-induced PsO).

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Zasocitinib
Phase: 3
Study Start date:
March 10, 2025
Estimated Completion Date:
January 26, 2028

Connect with a study center

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires B1878
    Argentina

    Active - Recruiting

  • Clinica Regional del Sud S.A.

    Río Cuarto, Córdoba Province X5804GAO
    Argentina

    Active - Recruiting

  • CIMER

    San Miguel de Tucumán, Tucumán Province T4000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucumán, Tucumán Province 4000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 4000
    Argentina

    Active - Recruiting

  • APRILLUS Asistencia e Investigacion Clinica

    Buenos Aires, C1406AGA
    Argentina

    Active - Recruiting

  • Hospital General de Agudo Jose Maria Ramos Mejia

    Buenos Aires, C1221ADC
    Argentina

    Site Not Available

  • Hospital General de Agudo Jose Maria Ramos Mejia

    Buenos Aires 3435910, C1221ADC
    Argentina

    Site Not Available

  • Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina

    Córdoba, X5000
    Argentina

    Active - Recruiting

  • CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, 5400
    Argentina

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales NSW 2050
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Sunshine Coast University Private Hospital | Clinical Trials

    Sippy Downs, Queensland QLD 4575
    Australia

    Active - Recruiting

  • The Queen Elizabeth Hospital | Rheumatology Department

    Woodville South, South Australia SA 5011
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Palmyra Dc, Western Australia 6961
    Australia

    Active - Recruiting

  • Colin Bayliss Research and Teaching Unit

    Victoria Park, Western Australia WA 6100
    Australia

    Active - Recruiting

  • CMIP-Centro Mineiro de Pesquisa Ltda

    Juiz de Fora, Minas Gerais 36010-570
    Brazil

    Active - Recruiting

  • Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica

    Uberlândia, Minas Gerais 38405-320
    Brazil

    Active - Recruiting

  • EDUMED - Educacao em Saude SS Ltda

    Curitiba, Paraná 80440-210
    Brazil

    Active - Recruiting

  • LMK Servicos Medicos Sociedade Simples

    Porto Alegre, Rio Grande do Sul 90480-000
    Brazil

    Active - Recruiting

  • Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Active - Recruiting

  • CEPIC - Centro Paulista de Investigacao Clinica

    São Paulo, 04266-010
    Brazil

    Active - Recruiting

  • Niagara Rheumatology Research Centre | Ontario, Canada

    Niagara Falls, Ontario L2E 6A6
    Canada

    Active - Recruiting

  • University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases

    Toronto 6167865, Ontario 6093943 M5T 2S8
    Canada

    Site Not Available

  • G.R.M.O. Inc.

    Québec, Quebec G1V 3M7
    Canada

    Active - Recruiting

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality 100730
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality 100191
    China

    Active - Recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality 100053
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100191
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guandong 519180
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou 1809858, Guandong 519180
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital

    Zhuzhou, Hunan 412007
    China

    Active - Recruiting

  • Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital

    Baotou Shi, Inner Mongolia 014010
    China

    Active - Recruiting

  • The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)

    Hangzhou, Jiangsu 215005
    China

    Active - Recruiting

  • Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225007
    China

    Active - Recruiting

  • Jiujiang No.1 People's Hospital

    Jiujiang Shi, Jiangxi 332000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330008
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330008
    China

    Active - Recruiting

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Pingxiang Pingxiang
    China

    Active - Recruiting

  • The 2nd Hospital of Xi'An Jiaotong University

    Xi'an, Shan'xi 710004
    China

    Active - Recruiting

  • Linyi People's Hospital

    Linyi Shi, Shandong 276000
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Pudong New District, Shanghai Municipality 200127
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)

    Taiyuan, Shanxi 030605
    China

    Active - Recruiting

  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)

    Taiyuan 1793511, Shanxi 1795912 030605
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu 1815286, 610072
    China

    Active - Recruiting

  • Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)

    Guangzhou, 510630
    China

    Active - Recruiting

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, 200052
    China

    Active - Recruiting

  • Wenzhou Medical University (WMU) - The First Affiliated Hospital

    Wenzhou, 325000
    China

    Active - Recruiting

  • Clinique de l'Infirmerie Protestante

    Caluire-et-Cuire, Auvergne-Rhône-Alpes 69300
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, Haute Garonne 31059
    France

    Active - Recruiting

  • CHRU de Tours

    Tours, Indre Et Loire 37044
    France

    Active - Recruiting

  • CHU de Reims

    Reims, Marne " 51100"
    France

    Active - Recruiting

  • Hopital Nord

    Saint-Etienne, 13015
    France

    Active - Recruiting

  • Universitatsklinikum Leipzig

    Leipzig, Saxony 4103
    Germany

    Active - Recruiting

  • Private Practice - Dr. Maren Sieburg

    Magdeburg, Saxony-Anhalt 39104
    Germany

    Active - Recruiting

  • ISA - Interdisciplinary Study Association

    Berlin, 10789
    Germany

    Active - Recruiting

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Rheumazentrum Ruhrgebiet

    Herne, 44649
    Germany

    Active - Recruiting

  • Kojunkai Social Medical Corporation Daido Clinic

    Minami-ku, Nagoya-shi, Aichi-ken 457-8511
    Japan

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken 467-8602
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, Hukuoka 814-0180
    Japan

    Active - Recruiting

  • Kita-Harima Medical Center

    Ono-shi, Hyōgo 675-1392
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, Mie, Mie-ken 514-8507
    Japan

    Active - Recruiting

  • National University Corporation Tohoku University Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi 983-8512
    Japan

    Active - Recruiting

  • National University Corporation Tohoku University Tohoku University Hospital

    Sendai 2111149, Miyagi 2111888 980-8574
    Japan

    Active - Recruiting

  • Sasebo Chuo Hospital

    Sasebo-shi, Nagasaki 857-1195
    Japan

    Active - Recruiting

  • Nippon Life Hospital

    Nishi Ward, Osaka 550-0006
    Japan

    Active - Recruiting

  • St. Luke's International Hospital

    Chuo-ku, Tokyo 104-8560
    Japan

    Active - Recruiting

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo 152-8902
    Japan

    Active - Recruiting

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo 153-8515
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Mitaka-shi, Tokyo-To 181-8611
    Japan

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-090
    Poland

    Active - Recruiting

  • Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland

    Krakow, Lesser Poland Voivodeship 30-033
    Poland

    Active - Recruiting

  • Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki

    Wroclaw, Lower Silesian Voivodeship 50-244
    Poland

    Active - Recruiting

  • dermMedica Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship 51-503
    Poland

    Active - Recruiting

  • dermMedica Sp. z o.o.

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 51-503
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship 81-338
    Poland

    Active - Recruiting

  • Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland

    Częstochowa, Silesian Voivodeship 42-217
    Poland

    Active - Recruiting

  • Centrum Kliniczno Badawcze | Elblag, Poland

    Elblag, Warmian-Masurian Voivodeship 82-300
    Poland

    Active - Recruiting

  • Clinical Research Center Sp z o o Medic-R Sp K

    Poznan, Wielkopolska 61-731
    Poland

    Active - Recruiting

  • Medyczne Centrum Hetmańska Piotr Leszczyński

    Poznan, Wielkopolska 60-128
    Poland

    Active - Recruiting

  • Medyczne Centrum Hetmańska Piotr Leszczyński

    Poznan 3088171, Wielkopolska 60-128
    Poland

    Active - Recruiting

  • Klinika Reuma Park

    Warsaw, Wybierz Województwo 02-665
    Poland

    Active - Recruiting

  • Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland

    Czestochowa, 42-217
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych Reumed

    Lublin, 20-607
    Poland

    Active - Recruiting

  • dermMedica Sp. z o.o.

    Wrocław, 51-503
    Poland

    Site Not Available

  • Hospital Universitario Araba - Sede Hospital Txagorritxu

    Vitoria-Gasteiz, Basque Country 1009
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla | Rheumatology Department

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Accellacare Alcobendas

    Alcobendas, Madrid 28100
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Sagrado Corazón

    Seville, 41013
    Spain

    Active - Recruiting

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Active - Recruiting

  • Coventry and Warwickshire Partnership NHS Trust

    Coventry, West Midlands CV2 2DX
    United Kingdom

    Active - Recruiting

  • St Luke's Hospital - UK

    Bradford, West Yorkshire BD5 0NA
    United Kingdom

    Active - Recruiting

  • The Princess Alexandra Hospital NHS Trust

    Harlow, CM20 1QX
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Trust

    Oxford, OX3 9RP
    United Kingdom

    Site Not Available

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG
    United Kingdom

    Active - Recruiting

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

    Tucson, Arizona 85748
    United States

    Active - Recruiting

  • Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA

    Covina, California 91722
    United States

    Active - Recruiting

  • RASF- Clinical Research Center

    Boca Raton, Florida 33486-1390
    United States

    Active - Recruiting

  • Direct Helpers Medical Center

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • IRIS Research and Development | Plantation, FL

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • BayCare Medical Group

    St. Petersburg, Florida 33705
    United States

    Active - Recruiting

  • North Georgia Rheumatology Group PC

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • Clinic of Robert Hozman

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Advanced Rheumatology PC | Lansing, MI

    Lansing, Michigan 48910-5894
    United States

    Active - Recruiting

  • AARR- Kansas City Physician Partners

    Kansas City, Missouri 85032
    United States

    Active - Recruiting

  • DJL Clinical Research | Charlotte, NC

    Charlotte, North Carolina 28210
    United States

    Active - Recruiting

  • University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research | Ducansville, PA

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • AARR- Lone Star Arthritis & Rheumatology Associates

    Fort Worth, Texas 76109
    United States

    Active - Recruiting

  • Biopharma Informatic | Hassan

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston - The Woodlands

    The Woodlands, Texas 77382
    United States

    Active - Recruiting

  • Swedish Rheumatology Research

    Seattle, Washington 98122
    United States

    Active - Recruiting

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