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)

Status: Recruiting
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Age:

• The participant is aged 18 years or older at the time of signing the informed consent form (ICF).

• Disease Characteristics:

• The participant has a diagnosis of PsA.

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

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

• The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.

• The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

• Medications for PsA:

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

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

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

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

Locations
United States
Arizona
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Mesa
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Phoenix
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
RECRUITING
Tucson
California
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
RECRUITING
Covina
Florida
Direct Helpers Medical Center
RECRUITING
Hialeah
IRIS Research and Development | Plantation, FL
RECRUITING
Plantation
BayCare Medical Group
RECRUITING
St. Petersburg
Georgia
North Georgia Rheumatology Group PC
NOT_YET_RECRUITING
Lawrenceville
Illinois
Clinic of Robert Hozman
RECRUITING
Skokie
Kentucky
Graves Gilbert Clinic
RECRUITING
Bowling Green
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Michigan
Advanced Rheumatology PC | Lansing, MI
RECRUITING
Lansing
Missouri
AARR- Kansas City Physician Partners
RECRUITING
Kansas City
North Carolina
DJL Clinical Research | Charlotte, NC
RECRUITING
Charlotte
Ohio
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
RECRUITING
Cleveland
Pennsylvania
Altoona Center for Clinical Research | Ducansville, PA
RECRUITING
Duncansville
Texas
AARR- Lone Star Arthritis & Rheumatology Associates
RECRUITING
Fort Worth
Biopharma Informatic | Hassan
RECRUITING
Houston
Advanced Rheumatology of Houston - The Woodlands
RECRUITING
The Woodlands
Washington
Swedish Rheumatology Research
RECRUITING
Seattle
Other Locations
Argentina
APRILLUS Asistencia e Investigacion Clinica
RECRUITING
Buenos Aires
Hospital General de Agudo Jose Maria Ramos Mejia
NOT_YET_RECRUITING
Buenos Aires
Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina
NOT_YET_RECRUITING
Córdoba
Hospital Italiano de La Plata
NOT_YET_RECRUITING
La Plata
Instituto de Investigaciones Clinicas Quilmes
NOT_YET_RECRUITING
Quilmes
Clinica Regional del Sud S.A.
NOT_YET_RECRUITING
Río Cuarto
CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
NOT_YET_RECRUITING
San Juan
Centro de Investigaciones Reumatologicas
RECRUITING
San Miguel De Tucumán
CIMER
RECRUITING
San Miguel De Tucumán
Australia
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Camperdown
Fiona Stanley Hospital
NOT_YET_RECRUITING
Palmyra Dc
Sunshine Coast University Private Hospital | Clinical Trials
RECRUITING
Sippy Downs
Colin Bayliss Research and Teaching Unit
RECRUITING
Victoria Park
Westmead Hospital
RECRUITING
Westmead
The Queen Elizabeth Hospital | Rheumatology Department
NOT_YET_RECRUITING
Woodville South
Brazil
EDUMED - Educacao em Saude SS Ltda
NOT_YET_RECRUITING
Curitiba
CMIP-Centro Mineiro de Pesquisa Ltda
NOT_YET_RECRUITING
Juiz De Fora
LMK Servicos Medicos Sociedade Simples
RECRUITING
Porto Alegre
Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department
NOT_YET_RECRUITING
São José Do Rio Preto
CEPIC - Centro Paulista de Investigacao Clinica
RECRUITING
São Paulo
Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
NOT_YET_RECRUITING
Uberlândia
Canada
Niagara Rheumatology Research Centre | Ontario, Canada
RECRUITING
Niagara Falls
G.R.M.O. Inc.
RECRUITING
Québec
University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases
NOT_YET_RECRUITING
Toronto
University of Toronto Women's College Hospital (WCH)
NOT_YET_RECRUITING
Toronto
China
Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital
RECRUITING
Baotou
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital Of Bengbu Medical College
RECRUITING
Bengbu
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)
RECRUITING
Guangzhou
The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)
RECRUITING
Hangzhou
Jiujiang No.1 People's Hospital
RECRUITING
Jiujiang Shi
Linyi People's Hospital
RECRUITING
Linyi Shi
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
NOT_YET_RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Jiangxi Pingxiang People's Hospital
RECRUITING
Pingxiang
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Pudong New District
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
RECRUITING
Taiyuan
Wenzhou Medical University (WMU) - The First Affiliated Hospital
RECRUITING
Wenzhou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
RECRUITING
Wuhan
The 2nd Hospital of Xi'An Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
RECRUITING
Zhuzhou
France
Clinique de l'Infirmerie Protestante
RECRUITING
Caluire-et-cuire
CHU de Reims
RECRUITING
Reims
Hopital Nord
RECRUITING
Saint-etienne
CHU Toulouse
RECRUITING
Toulouse
CHRU de Tours
RECRUITING
Tours
Germany
ISA - Interdisciplinary Study Association
RECRUITING
Berlin
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
RECRUITING
Hamburg
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
Universitatsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Private Practice - Dr. Maren Sieburg
RECRUITING
Magdeburg
Japan
St. Luke's International Hospital
RECRUITING
Chuo-ku
Fukuoka University Hospital
RECRUITING
Fukuoka
National Hospital Organization Tokyo Medical Center
RECRUITING
Meguro-ku
Toho University Ohashi Medical Center
RECRUITING
Meguro-ku
Kojunkai Social Medical Corporation Daido Clinic
RECRUITING
Minami-ku, Nagoya-shi
Kyorin University Hospital
RECRUITING
Mitaka-shi
Nagoya City University Hospital
RECRUITING
Nagoya
Nippon Life Hospital
RECRUITING
Nishi Ward
Kita-Harima Medical Center
RECRUITING
Ono-shi
Hokkaido University Hospital
RECRUITING
Sapporo
Sasebo Chuo Hospital
RECRUITING
Sasebo-shi
National University Corporation Tohoku University Tohoku University Hospital
RECRUITING
Sendai
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Sendai
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Mie University Hospital
RECRUITING
Tsu, Mie
Poland
MICS Centrum Medyczne Bydgoszcz
NOT_YET_RECRUITING
Bydgoszcz
Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland
NOT_YET_RECRUITING
Częstochowa
Centrum Kliniczno Badawcze | Elblag, Poland
NOT_YET_RECRUITING
Elblag
Centrum Medyczne Pratia Gdynia
NOT_YET_RECRUITING
Gdynia
Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland
NOT_YET_RECRUITING
Krakow
Zespol Poradni Specjalistycznych Reumed
NOT_YET_RECRUITING
Lublin
Clinical Research Center Sp z o o Medic-R Sp K
NOT_YET_RECRUITING
Poznan
Medyczne Centrum Hetmańska Piotr Leszczyński
NOT_YET_RECRUITING
Poznan
Klinika Reuma Park
NOT_YET_RECRUITING
Warsaw
dermMedica Sp. z o.o.
NOT_YET_RECRUITING
Wroclaw
Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki
NOT_YET_RECRUITING
Wroclaw
Spain
Accellacare Alcobendas
RECRUITING
Alcobendas
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Marques de Valdecilla | Rheumatology Department
RECRUITING
Santander
Hospital Quirónsalud Sagrado Corazón
RECRUITING
Seville
Hospital Universitario Araba - Sede Hospital Txagorritxu
RECRUITING
Vitoria-gasteiz
United Kingdom
St Luke's Hospital - UK
NOT_YET_RECRUITING
Bradford
Coventry and Warwickshire Partnership NHS Trust
NOT_YET_RECRUITING
Coventry
The Princess Alexandra Hospital NHS Trust
NOT_YET_RECRUITING
Harlow
King's College Hospital
NOT_YET_RECRUITING
London
Oxford University Hospitals NHS Trust
NOT_YET_RECRUITING
Oxford
Haywood Hospital
RECRUITING
Stoke-on-trent
The Royal Wolverhampton NHS Trust
NOT_YET_RECRUITING
Wolverhampton
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2028-01-26
Participants
Target number of participants: 600
Treatments
Experimental: Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Experimental: Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Experimental: Placebo + Zasoctinib
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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