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

Last updated: April 15, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriasis And Psoriatic Disorders

Arthritis And Arthritic Pain

Treatment

Placebo

Zasocitinib

Clinical Study ID

NCT06671496
TAK-279-PsA-3002
2024-513112-99-00
  • 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 had signs and symptoms consistent with PsA for at least 3months.

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

  4. 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.

  5. 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:

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

  7. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR

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

  9. 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: Placebo
Phase: 3
Study Start date:
March 10, 2025
Estimated Completion Date:
January 26, 2028

Connect with a study center

  • Hospital Italiano de La Plata

    LaPlata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires B1878
    Argentina

    Site Not Available

  • Clinica Regional del Sud S.A.

    Rio Cuarto, Cordoba X5804GAO
    Argentina

    Site Not Available

  • CIMER

    San Miguel De Tucumán, Tucuman T4000
    Argentina

    Site Not Available

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • APRILLUS Asistencia e Investigacion Clinica

    Buenos Aires, C1406AGA
    Argentina

    Site Not Available

  • Hospital General de Agudo Jose Maria Ramos Mejia

    Buenos Aires, C1221ADC
    Argentina

    Site Not Available

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

    Cordoba, X5000
    Argentina

    Site Not Available

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

    San Juan, 5400
    Argentina

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales NSW 2050
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Sunshine Coast University Private Hospital | Clinical Trials

    Sippy Downs, Queensland QLD 4575
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital | Rheumatology Department

    Woodville South, South Australia SA 5011
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Palmyra Dc, Western Australia 6961
    Australia

    Site Not Available

  • Colin Bayliss Research and Teaching Unit

    Victoria Park, Western Australia WA 6100
    Australia

    Site Not Available

  • CMIP-Centro Mineiro de Pesquisa Ltda

    Juiz De Fora, Minas Gerais 36010-570
    Brazil

    Site Not Available

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

    Uberlandia, Minas Gerais 38405-320
    Brazil

    Site Not Available

  • EDUMED - Educacao em Saude SS Ltda

    Curitiba, PR 80440-210
    Brazil

    Site Not Available

  • LMK Servicos Medicos Sociedade Simples

    Porto Alegre, RS 90480-000
    Brazil

    Site Not Available

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

    Sao Jose do Rio Preto, Sao Paulo 15090-000
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigacao Clinica

    Sao Paulo, 04266-010
    Brazil

    Site Not Available

  • Niagara Rheumatology Research Centre | Ontario, Canada

    Niagara Falls, Ontario L2E 6A6
    Canada

    Site Not Available

  • 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 of Toronto Women's College Hospital (WCH)

    Toronto, Ontario M5S 1B2
    Canada

    Site Not Available

  • G.R.M.O. Inc.

    Quebec, G1V 3M7
    Canada

    Site Not Available

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guandong 519180
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

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

    Luoyang, Henan 471000
    China

    Site Not Available

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

    Wuhan, Hubei 430022
    China

    Site Not Available

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

    Zhuzhou Shi, Hunan Sheng 412007
    China

    Site Not Available

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

    Baotou Shi, Inner Mongolia Autonomous Region 014010
    China

    Site Not Available

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

    Hangzhou, Jiangsu 215005
    China

    Site Not Available

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

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225007
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • Jiujiang No.1 People's Hospital

    Jiujiang Shi, Jiangxi Sheng 332000
    China

    Site Not Available

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Pingxiang Pingxiang
    China

    Site Not Available

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Pudong New District, Shanghai 200127
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

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

    Taiyuan Shi, Shanxi 030605
    China

    Site Not Available

  • The 2nd Hospital of Xi'An Jiaotong University

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Linyi People's Hospital

    Linyi Shi, Sichuan 276000
    China

    Site Not Available

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

    Chengdu, 610072
    China

    Site Not Available

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

    Guangzhou, 510630
    China

    Site Not Available

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, 200052
    China

    Site Not Available

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

    Wenzhou Shi, 325000
    China

    Site Not Available

  • Clinique de l'Infirmerie Protestante

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

    Site Not Available

  • CHU Toulouse

    Toulouse cedex 9, Haute Garonne 31059
    France

    Site Not Available

  • CHRU de Tours

    Tours cedex 9, Indre Et Loire 37044
    France

    Site Not Available

  • CHU de Reims

    Reims, Marne " 51100"
    France

    Site Not Available

  • Hopital Nord

    St Etienne, 13015
    France

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, Sachsen 4103
    Germany

    Site Not Available

  • Private Practice - Dr. Maren Sieburg

    Magdeburg, Sachsen-Anhalt 39104
    Germany

    Site Not Available

  • ISA - Interdisciplinary Study Association

    Berlin, 10789
    Germany

    Site Not Available

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg

    Hamburg, 20095
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, 44649
    Germany

    Site Not Available

  • Kojunkai Social Medical Corporation Daido Clinic

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

    Site Not Available

  • Nagoya City University Hospital

    Nagoya-City, Aichi 467-8602
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo-shi, Hokkaido 060-8648
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-Shi, Hukuoka 814-0180
    Japan

    Site Not Available

  • Kita-Harima Medical Center

    Ono-shi, Hyogo 675-1392
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, Mie, Mie-Ken 514-8507
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai City, Miyagi 983-8512
    Japan

    Site Not Available

  • National University Corporation Tohoku University Tohoku University Hospital

    Sendai-shi, Miyagi-Ken 980-8574
    Japan

    Site Not Available

  • Sasebo Chuo Hospital

    Sasebo-shi, Nagasaki 857-1195
    Japan

    Site Not Available

  • Nippon Life Hospital

    Nishi Ward, Osaka 550-0006
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuo-ku, Tokyo 104-8560
    Japan

    Site Not Available

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo 152-8902
    Japan

    Site Not Available

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo 153-8515
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka-shi, Tokyo-To 181-8611
    Japan

    Site Not Available

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

    Wroclaw, Dolnoslaskie 50-244
    Poland

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, Kujawsko Pomorskie 85-090
    Poland

    Site Not Available

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

    Krakow, Malopolskie 30-033
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Centrum Kliniczno Badawcze | Elblag, Poland

    Elblag, Warminsko-Mazurskie 82-300
    Poland

    Site Not Available

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

    Poznan, Wielkopolska 61-731
    Poland

    Site Not Available

  • Medyczne Centrum Hetmańska Piotr Leszczyński

    Poznań, Wielkopolska 60-128
    Poland

    Site Not Available

  • Klinika Reuma Park

    Warsaw, Wybierz Województwo 02-665
    Poland

    Site Not Available

  • Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland

    Czestochowa, 42-217
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych Reumed

    Lublin, 20-607
    Poland

    Site Not Available

  • dermMedica Sp. z o.o.

    Wrocław, 51-503
    Poland

    Site Not Available

  • Hospital Universitario Marques de Valdecilla | Rheumatology Department

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Accellacare Alcobendas

    Alcobendas, Madrid 28100
    Spain

    Site Not Available

  • Hospital Universitario Araba - Sede Hospital Txagorritxu

    Vitoria, Pais Vasco 1009
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320
    Spain

    Site Not Available

  • Hospital Quirónsalud Sagrado Corazón

    Sevilla, 41013
    Spain

    Site Not Available

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • Coventry and Warwickshire Partnership NHS Trust

    Coventry, West Midlands CV2 2DX
    United Kingdom

    Site Not Available

  • St Luke's Hospital - UK

    Bradford, West Yorkshire BD5 0NA
    United Kingdom

    Site Not Available

  • The Princess Alexandra Hospital NHS Trust

    Harlow, CM20 1QX
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Trust

    Oxford, OX3 9RP
    United Kingdom

    Site Not Available

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG
    United Kingdom

    Site Not Available

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

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

    Mesa, Arizona 85210
    United States

    Site Not Available

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

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • North Georgia Rheumatology Group PC

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Clinic of Robert Hozman

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Advanced Rheumatology PC | Lansing, MI

    Lansing, Michigan 48910-5894
    United States

    Site Not Available

  • AARR- Kansas City Physician Partners

    Kansas City, Missouri 85032
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • Biopharma Informatic | Hassan

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston - The Woodlands

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • Swedish Rheumatology Research

    Seattle, Washington 98122
    United States

    Site Not Available

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