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A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
NCT06671496 · Takeda
In plain English
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Official title
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)
About this study
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 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 design
Enrollment target: 600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-10
Estimated completion: 2028-01-26
Last updated: 2026-04-06
Interventions
Drug: ZasocitinibDrug: Placebo
Primary outcomes
- • Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo (At Week 16)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (122)
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZRecruiting
Tucson, Arizona, United States
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CARecruiting
Covina, California, United States
RASF- Clinical Research CenterRecruiting
Boca Raton, Florida, United States
Direct Helpers Medical CenterRecruiting
Hialeah, Florida, United States
IRIS Research and Development | Plantation, FLRecruiting
Plantation, Florida, United States
BayCare Medical GroupRecruiting
St. Petersburg, Florida, United States
North Georgia Rheumatology Group PCRecruiting
Lawrenceville, Georgia, United States
Clinic of Robert HozmanRecruiting
Skokie, Illinois, United States
Graves Gilbert ClinicRecruiting
Bowling Green, Kentucky, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Advanced Rheumatology PC | Lansing, MIRecruiting
Lansing, Michigan, United States
AARR- Kansas City Physician PartnersRecruiting
Kansas City, Missouri, United States
DJL Clinical Research | Charlotte, NCRecruiting
Charlotte, North Carolina, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology DivisionRecruiting
Cleveland, Ohio, United States
Altoona Center for Clinical Research | Ducansville, PARecruiting
Duncansville, Pennsylvania, United States
AARR- Lone Star Arthritis & Rheumatology AssociatesRecruiting
Fort Worth, Texas, United States
Biopharma Informatic | HassanRecruiting
Houston, Texas, United States
Advanced Rheumatology of Houston - The WoodlandsRecruiting
The Woodlands, Texas, United States
Swedish Rheumatology ResearchRecruiting
Seattle, Washington, United States
Instituto de Investigaciones Clinicas QuilmesRecruiting
Quilmes, Buenos Aires, Argentina
Clinica Regional del Sud S.A.Recruiting
Río Cuarto, Córdoba Province, Argentina
Centro de Investigaciones ReumatologicasRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
CIMERRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital General de Agudo Jose Maria Ramos MejiaNot Yet Recruiting
Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion ClinicaRecruiting
Buenos Aires, Argentina
Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, ArgentinaRecruiting
Córdoba, Argentina
CER San Juan, Centro Polivalente de Asistencia e Investigacion ClinicaRecruiting
San Juan, Argentina
Royal Prince Alfred HospitalRecruiting
Camperdown, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Sunshine Coast University Private Hospital | Clinical TrialsRecruiting
Sippy Downs, Queensland, Australia
The Queen Elizabeth Hospital | Rheumatology DepartmentRecruiting
Woodville South, South Australia, Australia
Fiona Stanley HospitalRecruiting
Palmyra Dc, Western Australia, Australia
Colin Bayliss Research and Teaching UnitRecruiting
Victoria Park, Western Australia, Australia
CMIP-Centro Mineiro de Pesquisa LtdaRecruiting
Juiz de Fora, Minas Gerais, Brazil
Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa ClinicaRecruiting
Uberlândia, Minas Gerais, Brazil
EDUMED - Educacao em Saude SS LtdaRecruiting
Curitiba, Paraná, Brazil
LMK Servicos Medicos Sociedade SimplesRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology DepartmentRecruiting
São José do Rio Preto, São Paulo, Brazil
CEPIC - Centro Paulista de Investigacao ClinicaRecruiting
São Paulo, Brazil
Niagara Rheumatology Research Centre | Ontario, CanadaRecruiting
Niagara Falls, Ontario, Canada
University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic DiseasesNot Yet Recruiting
Toronto, Ontario, Canada
G.R.M.O. Inc.Recruiting
Québec, Quebec, Canada
The First Affiliated Hospital Of Bengbu Medical CollegeRecruiting
Bengbu, Anhui, China
Xuanwu Hospital Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, China
Peking University Third HospitalRecruiting
Beijing, Beijing Municipality, China
Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, Fujian, China
Guangzhou First People's HospitalRecruiting
Guangzhou, Guandong, China
Shenzhen People's HospitalRecruiting
Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
Luoyang, Henan, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)Recruiting
Wuhan, Hubei, China
Central South University - Xiangya School of Medicine - Zhuzhou Central HospitalRecruiting
Zhuzhou, Hunan, China
Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated HospitalRecruiting
Baotou Shi, Inner Mongolia, China
The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)Recruiting
Hangzhou, Jiangsu, China
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)Recruiting
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong UniversityRecruiting
Nantong, Jiangsu, China
Northern Jiangsu People's HospitalRecruiting
Yangzhou, Jiangsu, China
Jiujiang No.1 People's HospitalRecruiting
Jiujiang Shi, Jiangxi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Jiangxi Pingxiang People's HospitalRecruiting
Pingxiang, Pingxiang, China
The 2nd Hospital of Xi'An Jiaotong UniversityRecruiting
Xi'an, Shan'xi, China
Linyi People's HospitalRecruiting
Linyi Shi, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
Pudong New District, Shanghai Municipality, China
First Hospital of Shanxi Medical UniversityRecruiting
Taiyuan, Shanxi, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)Recruiting
Taiyuan, Shanxi, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalRecruiting
Chengdu, China
Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)Recruiting
Guangzhou, China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineRecruiting
Shanghai, China
Wenzhou Medical University (WMU) - The First Affiliated HospitalRecruiting
Wenzhou, China
Clinique de l'Infirmerie ProtestanteRecruiting
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
CHU ToulouseRecruiting
Toulouse, Haute Garonne, France
CHRU de ToursRecruiting
Tours, Indre Et Loire, France
CHU de ReimsRecruiting
Reims, Marne, France
Hopital NordRecruiting
Saint-Etienne, France
Universitatsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Private Practice - Dr. Maren SieburgRecruiting
Magdeburg, Saxony-Anhalt, Germany
ISA - Interdisciplinary Study AssociationRecruiting
Berlin, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - HamburgRecruiting
Hamburg, Germany
Rheumazentrum RuhrgebietRecruiting
Herne, Germany
Kojunkai Social Medical Corporation Daido ClinicRecruiting
Minami-ku, Nagoya-shi, Aichi-ken, Japan
Nagoya City University HospitalRecruiting
Nagoya, Aichi-ken, Japan
Hokkaido University HospitalRecruiting
Sapporo, Hokkaido, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Hukuoka, Japan
Kita-Harima Medical CenterRecruiting
Ono-shi, Hyōgo, Japan
Mie University HospitalRecruiting
Tsu, Mie, Mie-ken, Japan
National University Corporation Tohoku University Tohoku University HospitalRecruiting
Sendai, Miyagi, Japan
Tohoku Medical and Pharmaceutical University HospitalRecruiting
Sendai, Miyagi, Japan
Sasebo Chuo HospitalRecruiting
Sasebo-shi, Nagasaki, Japan
Nippon Life HospitalRecruiting
Nishi Ward, Osaka, Japan
St. Luke's International HospitalRecruiting
Chuo-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical CenterRecruiting
Meguro-Ku, Tokyo, Japan
Toho University Ohashi Medical CenterRecruiting
Meguro-ku, Tokyo, Japan
Tokyo Medical University HospitalRecruiting
Shinjuku-Ku, Tokyo, Japan
Kyorin University HospitalRecruiting
Mitaka-shi, Tokyo-To, Japan
MICS Centrum Medyczne BydgoszczRecruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, PolandRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Reum-Medica s.c. Bozena Kowalewska, Marek ZawadzkiRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
dermMedica Sp. z o.o.Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Pratia GdyniaRecruiting
Gdynia, Pomeranian Voivodeship, Poland
Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, PolandRecruiting
Częstochowa, Silesian Voivodeship, Poland
Centrum Kliniczno Badawcze | Elblag, PolandRecruiting
Elblag, Warmian-Masurian Voivodeship, Poland
Medyczne Centrum Hetmańska Piotr LeszczyńskiRecruiting
Poznan, Wielkopolska, Poland
Clinical Research Center Sp z o o Medic-R Sp KRecruiting
Poznan, Wielkopolska, Poland
Klinika Reuma ParkRecruiting
Warsaw, Wybierz Województwo, Poland
Zespol Poradni Specjalistycznych ReumedRecruiting
Lublin, Poland
Hospital Universitario Araba - Sede Hospital TxagorritxuRecruiting
Vitoria-Gasteiz, Basque Country, Spain
Hospital Universitario Marques de Valdecilla | Rheumatology DepartmentRecruiting
Santander, Cantabria, Spain
Accellacare AlcobendasRecruiting
Alcobendas, Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario de CanariasRecruiting
Santa Cruz de Tenerife, Spain
Hospital Quirónsalud Sagrado CorazónRecruiting
Seville, Spain
King's College HospitalRecruiting
London, Greater London, United Kingdom
Coventry and Warwickshire Partnership NHS TrustRecruiting
Coventry, West Midlands, United Kingdom
St Luke's Hospital - UKRecruiting
Bradford, West Yorkshire, United Kingdom
The Princess Alexandra Hospital NHS TrustRecruiting
Harlow, United Kingdom
Oxford University Hospitals NHS TrustNot Yet Recruiting
Oxford, United Kingdom
Haywood HospitalRecruiting
Stoke-on-Trent, United Kingdom
The Royal Wolverhampton NHS TrustRecruiting
Wolverhampton, United Kingdom