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

September 8, 2026 updated by: Takeda

A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • APRILLUS Asistencia e Investigacion Clinica
        • Principal Investigator:
          • Pablo Alejandro Mannucci Walter
        • Contact:
      • Buenos Aires, Argentina, C1221ADC
        • Withdrawn
        • Hospital General de Agudo Jose Maria Ramos Mejia
      • Córdoba, Argentina, X5000
        • Recruiting
        • Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina
        • Contact:
        • Principal Investigator:
          • Veronica Savio
      • San Juan, Argentina, 5400
        • Recruiting
        • CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
        • Contact:
        • Principal Investigator:
          • Jose Moreno
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878
        • Recruiting
        • Instituto de Investigaciones Clinicas Quilmes
        • Contact:
        • Principal Investigator:
          • Jose Luiz Velasco Zamora
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5804GAO
        • Recruiting
        • Clinica Regional del Sud S.A.
        • Contact:
        • Principal Investigator:
          • Hernan Maldonado Ficco
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Recruiting
        • Centro de Investigaciones Reumatológicas
        • Contact:
        • Principal Investigator:
          • Maria Silvia Yacuzzi
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Recruiting
        • CIMER
        • Contact:
        • Principal Investigator:
          • Rodolfo Perez Alamino
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, NSW 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Peter Youssef
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Sippy Downs, Queensland, Australia, QLD 4575
        • Recruiting
        • Sunshine Coast University Private Hospital | Clinical Trials
        • Contact:
        • Principal Investigator:
          • Susan Thackwray
    • South Australia
      • Woodville South, South Australia, Australia, SA 5011
        • Recruiting
        • The Queen Elizabeth Hospital | Rheumatology Department
        • Principal Investigator:
          • Maureen Rischmueller
        • Contact:
    • Western Australia
      • Palmyra Dc, Western Australia, Australia, 6961
      • Victoria Park, Western Australia, Australia, WA 6100
        • Recruiting
        • Colin Bayliss Research and Teaching Unit
        • Principal Investigator:
          • Robert Will
        • Contact:
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica
        • Contact:
        • Principal Investigator:
          • Flora Marcolino
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • Cmip-Centro Mineiro de Pesquisa Ltda
        • Principal Investigator:
          • Viviane Angelina de Souza
        • Contact:
      • Uberlândia, Minas Gerais, Brazil, 38405-320
        • Recruiting
        • Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
        • Contact:
        • Principal Investigator:
          • Roberto Ranza
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-210
        • Recruiting
        • EDUMED - Educacao em Saude SS Ltda
        • Principal Investigator:
          • Valderilio Feijo Azevedo
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Recruiting
        • LMK Servicos Medicos Sociedade Simples
        • Contact:
        • Principal Investigator:
          • Aline Streck
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Ricardo Acayaba De Toledo
  • Canada
    • Ontario
      • Niagara Falls, Ontario, Canada, L2E 6A6
        • Recruiting
        • Niagara Rheumatology Research Centre | Ontario, Canada
        • Contact:
        • Principal Investigator:
          • Rajwinder Dhillon
      • Toronto, Ontario, Canada, M5T 2S8
        • Withdrawn
        • University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases
    • Quebec
      • Québec, Quebec, Canada, G1V 3M7
        • Recruiting
        • G.R.M.O. Inc.
        • Contact:
        • Principal Investigator:
          • Philippe Desaulniers
  • China
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Jiang Su
      • Guangzhou, China, 510630
        • Recruiting
        • Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)
        • Contact:
        • Principal Investigator:
          • Jie-ruo Gu
      • Shanghai, China, 200052
        • Recruiting
        • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
        • Contact:
        • Principal Investigator:
          • Ting Jiang
      • Wenzhou, China, 325000
        • Recruiting
        • Wenzhou Medical University (WMU) - The First Affiliated Hospital
        • Principal Investigator:
          • li Sun
        • Contact:
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Principal Investigator:
          • Changhao Xie
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Xiaofeng Zeng
        • Contact:
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Yi Zhao
        • Contact:
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Rong Mu
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital Of Xiamen University
        • Contact:
        • Principal Investigator:
          • Guixiu Shi
    • Guandong
      • Guangzhou, Guandong, China, 519180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoyan Cai
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Principal Investigator:
          • Dongzhou Liu
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471000
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Xiaofei Shi
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
        • Contact:
        • Principal Investigator:
          • Qiubai Li
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Recruiting
        • Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Jing-yang Li
    • Inner Mongolia
      • Baotou Shi, Inner Mongolia, China, 014010
        • Recruiting
        • Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Yong-fu Wang
    • Jiangsu
      • Hangzhou, Jiangsu, China, 215005
        • Recruiting
        • The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)
        • Contact:
        • Principal Investigator:
          • Min Wu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
        • Contact:
        • Principal Investigator:
          • Yao Ke
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
        • Principal Investigator:
          • Zhanyun Da
      • Yangzhou, Jiangsu, China, 225007
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
        • Principal Investigator:
          • Hua Wei
    • Jiangxi
      • Jiujiang Shi, Jiangxi, China, 332000
        • Recruiting
        • Jiujiang No.1 People's Hospital
        • Contact:
        • Principal Investigator:
          • Ju Liu
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Rui Wu
      • Nanchang, Jiangxi, China, 330008
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Xin-Wang Duan
    • Pingxiang
      • Pingxiang, Pingxiang, China, Pingxiang
        • Recruiting
        • Jiangxi Pingxiang People's Hospital
        • Principal Investigator:
          • Jiankang Hu
        • Contact:
    • Shan'xi
      • Xi'an, Shan'xi, China, 710004
        • Recruiting
        • The 2nd Hospital of Xi'An Jiaotong University
        • Contact:
        • Principal Investigator:
          • Xueyi Li
    • Shandong
      • Linyi Shi, Shandong, China, 276000
        • Recruiting
        • Linyi People's Hospital
        • Contact:
        • Principal Investigator:
          • Zunzhong Li
    • Shanghai Municipality
      • Pudong New District, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Principal Investigator:
          • Ting Li
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Zili Fu
      • Taiyuan, Shanxi, China, 030605
        • Recruiting
        • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
        • Contact:
        • Principal Investigator:
          • Li-yun Zhang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Yi Liu
        • Contact:
  • France
    • Auvergne-Rhône-Alpes
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recruiting
        • CHU Toulouse
        • Contact:
        • Principal Investigator:
          • Arnaud Constantin
    • Indre Et Loire
      • Tours, Indre Et Loire, France, 37044
        • Recruiting
        • CHRU de Tours
        • Contact:
        • Principal Investigator:
          • Philippe Goupille
    • Marne
      • Reims, Marne, France, " 51100"
        • Recruiting
        • CHU de Reims
        • Principal Investigator:
          • Jean-Hugues Salmon
        • Contact:
  • Germany
      • Berlin, Germany, 10789
        • Recruiting
        • ISA - Interdisciplinary Study Association
        • Contact:
        • Principal Investigator:
          • Margit Simon
      • Hamburg, Germany, 20095
        • Recruiting
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
        • Principal Investigator:
          • Andrea Everding
        • Contact:
      • Herne, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet
        • Principal Investigator:
          • Ioana Andreica
        • Contact:
    • Saxony
      • Leipzig, Saxony, Germany, 4103
        • Recruiting
        • Universitatsklinikum Leipzig
        • Contact:
        • Principal Investigator:
          • Ulf Wagner
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39104
        • Completed
        • Private Practice - Dr. Maren Sieburg
  • Japan
    • Aichi-ken
      • Minami-ku, Nagoya-shi, Aichi-ken, Japan, 457-8511
        • Recruiting
        • Kojunkai Social Medical Corporation Daido Clinic
        • Principal Investigator:
          • Yoichiro Haji
        • Contact:
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Principal Investigator:
          • Akimichi Morita
        • Contact:
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Principal Investigator:
          • Michihito Kono
        • Contact:
    • Hukuoka
      • Fukuoka, Hukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Principal Investigator:
          • Shinichi Imafuku
        • Contact:
    • Hyōgo
      • Ono-shi, Hyōgo, Japan, 675-1392
        • Recruiting
        • Kita-Harima Medical Center
        • Principal Investigator:
          • Kenta Misaki
        • Contact:
    • Mie-ken
      • Tsu, Mie, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Contact:
        • Principal Investigator:
          • Keiichi Yamanaka
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8512
        • Recruiting
        • Tohoku Medical and Pharmaceutical University Hospital
        • Principal Investigator:
          • Tomonori Ishii
        • Contact:
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • National University Corporation Tohoku University Tohoku University Hospital
        • Principal Investigator:
          • Hiroshi Fujii
        • Contact:
    • Nagasaki
      • Sasebo-shi, Nagasaki, Japan, 857-1195
        • Recruiting
        • Sasebo Chuo Hospital
        • Principal Investigator:
          • Yukitaka Ueki
        • Contact:
    • Osaka
      • Nishi Ward, Osaka, Japan, 550-0006
        • Recruiting
        • Nippon Life Hospital
        • Contact:
        • Principal Investigator:
          • Shigeyoshi Tsuji
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital
        • Contact:
        • Principal Investigator:
          • Satoshi Kawaai
      • Meguro-Ku, Tokyo, Japan, 152-8902
        • Recruiting
        • National Hospital Organization Tokyo Medical Center
        • Contact:
        • Principal Investigator:
          • Katsuya Suzuki
      • Meguro-ku, Tokyo, Japan, 153-8515
      • Shinjuku-Ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Yukari Okubo
    • Tokyo-To
      • Mitaka-shi, Tokyo-To, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital
        • Contact:
        • Principal Investigator:
          • Mitsumasa Kishimoto
  • Poland
      • Lublin, Poland, 20-607
        • Recruiting
        • Zespol Poradni Specjalistycznych REUMED
        • Principal Investigator:
          • Marcin Mazurek
        • Contact:
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-090
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • Recruiting
        • Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland
        • Principal Investigator:
          • Grazyna Pulka
        • Contact:
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-244
        • Recruiting
        • Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki
        • Contact:
        • Principal Investigator:
          • Marek Zawadzki
      • Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
        • Recruiting
        • dermMedica Sp. z o.o.
        • Principal Investigator:
          • Jolanta Weglowska
        • Contact:
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Recruiting
        • Centrum Medyczne Pratia Gdynia
        • Contact:
        • Principal Investigator:
          • Anna Sylwestrzak
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Poland, 42-217
        • Recruiting
        • Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland
        • Contact:
        • Principal Investigator:
          • Renata Wysocka Znojkiewicz
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno Badawcze | Elblag, Poland
        • Principal Investigator:
          • Jan Brzezicki
        • Contact:
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60-128
        • Recruiting
        • Medyczne Centrum Hetmańska Piotr Leszczyński
        • Contact:
        • Principal Investigator:
          • Piotr Leszczynski
      • Poznan, Wielkopolska, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp z o o Medic-R Sp K
        • Principal Investigator:
          • Maria Jaraczewska-Baumann
        • Contact:
    • Wybierz Województwo
      • Warsaw, Wybierz Województwo, Poland, 02-665
        • Recruiting
        • Klinika Reuma Park
        • Principal Investigator:
          • Janusz Jaworski
        • Contact:
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Eugenio De Miguel
      • Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
        • Principal Investigator:
          • Jose Federico Di-az-Gonzalez
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Quironsalud Sagrado Corazon
        • Principal Investigator:
          • Paula Cejas Caceres
        • Contact:
    • Basque Country
      • Vitoria-Gasteiz, Basque Country, Spain, 1009
        • Recruiting
        • Hospital Universitario Araba - Sede Hospital Txagorritxu
        • Contact:
        • Principal Investigator:
          • Margarida Vasques Rocha
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla | Rheumatology Department
        • Principal Investigator:
          • Ricardo Blanco Alonso
        • Contact:
    • Madrid
      • Alcobendas, Madrid, Spain, 28100
        • Recruiting
        • Accellacare Alcobendas
        • Contact:
        • Principal Investigator:
          • Raul Maria Veiga Cabello
  • United Kingdom
      • Harlow, United Kingdom, CM20 1QX
        • Recruiting
        • The Princess Alexandra Hospital NHS Trust
        • Principal Investigator:
          • Khalid Ahmed
        • Contact:
      • Oxford, United Kingdom, OX3 9RP
        • Withdrawn
        • Oxford University Hospitals NHS Trust
      • Stoke-on-Trent, United Kingdom, ST6 7AG
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • The Royal Wolverhampton NHS Trust
        • Contact:
        • Principal Investigator:
          • Nick Barkham
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
        • Principal Investigator:
          • James Galloway
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • Recruiting
        • Coventry and Warwickshire Partnership NHS Trust
        • Contact:
        • Principal Investigator:
          • Nicola Gullick
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • Recruiting
        • St Luke's Hospital - UK
        • Contact:
        • Principal Investigator:
          • Philip Helliwell
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
        • Principal Investigator:
          • Swati Bharadwaj
        • Contact:
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
        • Principal Investigator:
          • Joonhee Lim
        • Contact:
      • Tucson, Arizona, United States, 85748
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
        • Principal Investigator:
          • Jeffrey Loomer
        • Contact:
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
        • Principal Investigator:
          • Samy Metyas
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33486-1390
        • Recruiting
        • RASF- Clinical Research Center
        • Principal Investigator:
          • Shawn Baca
        • Contact:
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Medical Center
        • Principal Investigator:
          • Frank Don
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development | Plantation, FL
        • Principal Investigator:
          • Guillermo Valenzuela
        • Contact:
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • BayCare Medical Group
        • Contact:
        • Principal Investigator:
          • Sonialy Lugo Ruiz
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • North Georgia Rheumatology Group PC
        • Principal Investigator:
          • Theresa Lawrence Ford
        • Contact:
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Completed
        • Clinic of Robert Hozman
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Recruiting
        • Graves Gilbert Clinic
        • Principal Investigator:
          • Asad Fraser
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • Ana-Maria Orbai
    • Michigan
      • Lansing, Michigan, United States, 48910-5894
        • Recruiting
        • Advanced Rheumatology PC | Lansing, MI
        • Principal Investigator:
          • Monika Mohan
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 85032
        • Recruiting
        • AARR- Kansas City Physician Partners
        • Principal Investigator:
          • Tina Shah
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • DJL Clinical Research | Charlotte, NC
        • Principal Investigator:
          • Emily Jane Herron Box
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
        • Contact:
        • Principal Investigator:
          • Marina Magrey
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Principal Investigator:
          • Isam Diab
        • Contact:
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research | Ducansville, PA
        • Principal Investigator:
          • Alan Kivitz
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76109
        • Recruiting
        • AARR- Lone Star Arthritis & Rheumatology Associates
        • Principal Investigator:
          • Himabindu Reddy
        • Contact:
      • Houston, Texas, United States, 77089
        • Recruiting
        • Biopharma Informatic | Hassan
        • Contact:
        • Principal Investigator:
          • Laila Hassan
      • The Woodlands, Texas, United States, 77382
        • Recruiting
        • Advanced Rheumatology of Houston - The Woodlands
        • Principal Investigator:
          • Tamar Brionez
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Rheumatology Research
        • Principal Investigator:
          • Philip Mease
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age:

  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:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Drug: Zasocitinib
Zasocitinib tablets.
Other Names:
  • NDI-034858
  • TAK- 279
Experimental: Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Drug: Zasocitinib
Zasocitinib tablets.
Other Names:
  • NDI-034858
  • TAK- 279
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.
Drug: Zasocitinib
Zasocitinib tablets.
Other Names:
  • NDI-034858
  • TAK- 279
Drug: Placebo
Zasocitinib matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and >=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: At Week 16
The MDA is defined as a composite outcome measure of 7 ClinROs and PROs used in PsA. Participants are classified as achieving MDA if they fulfil 5 of 7 outcome measures: TJC68 less than or equal to (<=) 1, SJC66 <=1, psoriasis area and severity index (PASI) score <=1 or body surface area (BSA) affected by psoriasis <=3%, PtGA of PsA Pain score <=15, PtGA of PsA score <=20, HAQ-DI <=0.5, and Leeds Enthesitis Index (LEI) <=1. Percentage of participants achieving MDA at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 16
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
A PASI-75 response is defined as >=75% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease. Percentage of participants achieving PASI-75 response (in participants with a baseline >=3% body surface area [BSA]) for zasocitinib Dose A and B compared to placebo at Week 16 will be reported.
Baseline, at Week 16
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR50 response is defined as: >= 50% improvement from baseline in both SJC66 and TJC68, and >=50% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR50 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 16
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The HAQ-DI is defined as a 20-item PRO measure used to assess functional ability over the past week across 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of these categories, participant reports the amount of difficulty they have in performing 2 or 3 specific activities on a 4-point scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do) The use of assistive devices and personal assistance are also noted. The HAQ-DI score is calculated as the mean of the category scores (0 = no disability, 3 = completely disabled), with 0 being the most desirable outcome and 3 as the least desirable. Participants must have scores for at least 6 categories for the HAQ-DI to be computed. Change from baseline in the HAQ-DI score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR70 response is defined as: >=70% improvement from baseline in both SJC66 and TJC68, and >=70% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR70 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 16
Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo
Time Frame: Baseline, at Week 16
The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score PCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 PCS score at Week 16 for zasocitinib Dose A compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo
Time Frame: Baseline, at Week 16
The FACIT-fatigue score is defined as a 13-item PRO measure that assesses the severity of self-reported fatigue and its impact on daily functioning over the past 7 days. It includes items measuring tiredness, weakness, listlessness, lack of energy, and the effects on activities such as sleep and social interactions. Each item is rated on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The total score ranges from 0 to 52, with higher scores indicating less fatigue. Change from baseline in the FACIT- fatigue score at Week 16 for zasocitinib Dose A compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The LEI is defined as a 6-item ClinRO measure specifically developed for PsA. It assesses the presence or absence of pain/tenderness when 4 kilograms per centimeter square (kg/cm^2) of pressure is applied to 6 enthesial sites: the lateral epicondyles, medial femoral condyles, and Achilles tendon insertions on both sides of the body. Tenderness at each site is recorded on a dichotomous scale (0 = non-tender, 1 = tender). The total score is the sum of tender sites, ranging from 0 to 6, with a higher score indicating a greater enthesitis burden. Percentage of participants achieving LEI =0 (in participants with a baseline LEI >=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR response is defined as: improvement from baseline in both SJC66 and TJC68, and improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain (0-100 visual analogue scale [VAS]); PtGA of PsA (0-100 VAS); PGA of PsA (0-100 VAS); participant's assessment of physical function as measured by HAQ-DI (0-3 scale); hsCRP. Change from baseline in individual components of ACR response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The LDI is defined as a ClinRO measure use to assess the presence of dactylitis. It involves measuring the circumference of all 20 digits using a dactylometer, with measurements taken around the proximal phalanx as close to the web space as possible. Moderate pressure is applied to assess tenderness or pain in the affected digits. Tenderness is scored on a binary scale (0 = non-tender, 1 = tender). Only digits with a circumference ratio exceeding 10% are considered to have dactylitis. A higher score indicates worse dactylitis. Percentage of participants achieving LDI =0 (in participants with a baseline LDI >=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
A PASI-90 response is defined as >=90% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease. Percentage of participants achieving PASI-90 response (in participants with a baseline >=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
A PASI-100 response is defined as >=100% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease. Percentage of participants achieving PASI-100 response (in participants with a baseline >=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
ACR responses measure improvement in multiple criteria, a composite COA with ClinROs and PROs. An ACR50 response is >=50% improvement in SJC66 and TJC68, and 3 of 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA, HAQ-DI, hsCRP. A PASI-100 response is >=100% improvement in the PASI score from baseline. It's a ClinRO measuring psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored from 0 (no involvement) to 4 (very marked involvement). PASI scores range from 0 to 72, with <=3 as mild, >=3 to 15 as moderate, and >=15 as severe disease. Percentage of participants achieving ACR50 and PASI-100 response (in participants with a baseline >=3% BSA) simultaneously at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
Static physician's global assessment (sPGA) is defined as a 5-point ClinRO measure used to assess the current state of psoriasis based on severity of erythema, induration, and scaling. The total sPGA score ranges from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe, with higher scores indicating greater disease severity. Each lesion characteristic (erythema, induration, and scaling) is graded separately on a 5-point scale: erythema (0 = no evidence to 4 = bright red coloration), induration (0 = no evidence to 4 = severe plaque elevation), and scaling (0 = no evidence to 4 = thick scaling). Lesion scores for erythema, induration, and scaling are averaged and rounded to nearest whole number to compute total score. Percentage of participants achieving sPGA response of clear (0) or almost clear (1) with >=2-point decrease from baseline (in participants with a baseline sPGA >=2) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The HAQ-DI is defined as a 20-item PRO measure used to assess functional ability over the past week across 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each category includes 2-3 activities rated on a 4-point scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). Assistive devices and personal assistance are also noted. The HAQ-DI score is calculated as the mean of the category scores (0 = no disability, 3 = completely disabled), with scores of 0-1 indicating mild-to-moderate disability, 1-2 moderate-to-severe, and 2-3 severe-to-very severe disability. Participants must have scores for at least 6 categories for the HAQ-DI to be computed. Percentage of responders achieving minimal clinically important differences (reduction of >=0.35 from baseline) in HAQ-DI score from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 MCS score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The PsAID-12 is defined as a 12-item PRO measure that assesses symptoms such as pain, fatigue, and skin problems and the impact of PsA on the participant's life over the past week. It covers areas including work and/or leisure activities, physical activities, sleep, anxiety, embarrassment or shame, social participation, and depression. The response options are rated on a numerical rating scale (NRS) from 0 (none/no difficulty) to 10 (extreme difficulty), with higher scores indicating a greater impact of the disease. Change from baseline in PsAID-12 total score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The DAPSA is defined as a composite measure of peripheral joint disease activity that includes ClinROs, PROs, and a laboratory test. DAPSA is calculated as the sum of the following components: tender joint count (0-68), swollen joint count (0-66), hsCRP level (milligrams per deciliter [mg/dL]), PtGA of PsA pain (0-100 VAS), and PtGA of PsA (0-100 VAS). DAPSA cutoffs for disease activity are: remission (<=4), low disease activity (>4 to <=14), moderate disease activity (>14 to <=28), and high disease activity (>28). Change from baseline in DAPSA score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The DAS28 with high-sensitivity C-reactive protein is defined as a derived index combining the tender joint count (28 joints), swollen joint count (28 joints), hsCRP, and PtGA of PsA. The 28-joint count includes the shoulder, elbow, wrist, metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5 of both upper extremities, and the knee joints of both lower extremities. The DAS28 score ranges from 0 to 10, with higher scores indicating greater disease activity. Change from baseline in DAS28 C-reactive protein score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 16
The PGA-F is defined as a ClinRO measure assessing the severity of fingernail PsO. It evaluates nail bed signs (onycholysis, hyperkeratosis, erythema, splinter hemorrhages) and nail matrix signs (pitting, ridging, discoloration). Clinicians rate the severity using categories: clear (0), minimal (1), mild (2), moderate (3), and severe (4). The total score is based on the area with the most involvement (nail bed or matrix), ranging from 0 (clear) to 4 (very severe), with higher scores indicating more severe fingernail PsO. Change from baseline in PGA-F score in participants with PGA-F >0 from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo
Time Frame: Baseline, at Week 16
The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score PCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 PCS score at Week 16 for zasocitinib Dose B compared to placebo will be reported.
Baseline, at Week 16
Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo
Time Frame: Baseline, at Week 16
The FACIT-fatigue score is defined as a 13-item PRO measure that assesses the severity of self-reported fatigue and its impact on daily functioning over the past 7 days. It includes items measuring tiredness, weakness, listlessness, lack of energy, and the effects on activities such as sleep and social interactions. Each item is rated on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The total score ranges from 0 to 52, with higher scores indicating less fatigue. Change from baseline in the FACIT- fatigue score at Week 16 for zasocitinib Dose B compared to placebo will be reported.
Baseline, at Week 16
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline, at Week 4 and 8
A PASI-75 response is defined as >=75% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease. Percentage of participants achieving PASI-75 response (in participants with a baseline >=3% BSA) at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.
Baseline, at Week 4 and 8
Percentage of Participants Achieving a Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesis Index = 0 through Week 16 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: Baseline up to Week 16
The SPARCC Enthesis Index is a ClinRO measure that assesses the presence or absence of pain/tenderness when 4 kg/cm^2 of pressure is applied to 18 enthesial sites across the following 9 bilateral sites: Achilles tendons, plantar fascia insertion at the calcaneus, greater tuberosity of the humerus, medial epicondyles, lateral epicondyles, greater trochanter, quadriceps insertion, inferior patella, and tibial tuberosity. Tenderness at each site is recorded as either present (1) or absent (0). Total score is the sum of score from each site, ranging from 0 to 16, with higher scores indicating greater enthesis burden. Percentage of participants achieving a SPARCC Enthesis Index = 0 through Week 16 for zasocitinib Dose A and B compared to placebo will be reported
Baseline up to Week 16
Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo
Time Frame: At Week 8
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR20 response is defined as: >= 20% improvement from baseline in both SJC66 and TJC68, and >=20% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR20 response at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.
At Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

May 18, 2027

Study Completion (Estimated)

January 26, 2028

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-279-PsA-3002
  • 2024-513112-99-00 (Ctis)
  • jRCT2031250061 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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