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NCT06671496PHASE3Recruiting

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

Takeda

Start Date

3/10/2025

Completion Date

1/26/2028

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

Age Range: 18 years to No maximum

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).

Interventions

DRUG

Zasocitinib

DRUG

Placebo

Interested in This Trial?

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Conditions

Psoriatic Arthritis

Locations

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Mesa, Arizona 85210

United States

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Phoenix, Arizona 85032

United States

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Tucson, Arizona 85748

United States

Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA

Covina, California 91722

United States

RASF- Clinical Research Center

Boca Raton, Florida 33486-1390

United States

Direct Helpers Medical Center

Hialeah, Florida 33012

United States

IRIS Research and Development | Plantation, FL

Plantation, Florida 33324

United States

BayCare Medical Group

St. Petersburg, Florida 33705

United States

North Georgia Rheumatology Group PC

Lawrenceville, Georgia 30046

United States

Clinic of Robert Hozman

Skokie, Illinois 60076

United States

Graves Gilbert Clinic

Bowling Green, Kentucky 42101

United States

Johns Hopkins Hospital

Baltimore, Maryland 21205

United States

Advanced Rheumatology PC | Lansing, MI

Lansing, Michigan 48910-5894

United States

AARR- Kansas City Physician Partners

Kansas City, Missouri 85032

United States

DJL Clinical Research | Charlotte, NC

Charlotte, North Carolina 28210

United States

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

Cleveland, Ohio 44106

United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio 44130

United States

Altoona Center for Clinical Research | Ducansville, PA

Duncansville, Pennsylvania 16635

United States

AARR- Lone Star Arthritis & Rheumatology Associates

Fort Worth, Texas 76109

United States

Biopharma Informatic | Hassan

Houston, Texas 77089

United States

Advanced Rheumatology of Houston - The Woodlands

The Woodlands, Texas 77382

United States

Swedish Rheumatology Research

Seattle, Washington 98122

United States

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires B1878

Argentina

Clinica Regional del Sud S.A.

Río Cuarto, Córdoba Province X5804GAO

Argentina

Centro de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province 4000

Argentina

CIMER

San Miguel de Tucumán, Tucumán Province T4000

Argentina

Hospital General de Agudo Jose Maria Ramos Mejia

Buenos Aires, C1221ADC

Argentina

APRILLUS Asistencia e Investigacion Clinica

Buenos Aires, C1406AGA

Argentina

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

Córdoba, X5000

Argentina

CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, 5400

Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales NSW 2050

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Sunshine Coast University Private Hospital | Clinical Trials

Sippy Downs, Queensland QLD 4575

Australia

The Queen Elizabeth Hospital | Rheumatology Department

Woodville South, South Australia SA 5011

Australia

Fiona Stanley Hospital

Palmyra Dc, Western Australia 6961

Australia

Colin Bayliss Research and Teaching Unit

Victoria Park, Western Australia WA 6100

Australia

CMIP-Centro Mineiro de Pesquisa Ltda

Juiz de Fora, Minas Gerais 36010-570

Brazil

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

Uberlândia, Minas Gerais 38405-320

Brazil

EDUMED - Educacao em Saude SS Ltda

Curitiba, Paraná 80440-210

Brazil

LMK Servicos Medicos Sociedade Simples

Porto Alegre, Rio Grande do Sul 90480-000

Brazil

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

São José do Rio Preto, São Paulo 15090-000

Brazil

CEPIC - Centro Paulista de Investigacao Clinica

São Paulo, 04266-010

Brazil

Niagara Rheumatology Research Centre | Ontario, Canada

Niagara Falls, Ontario L2E 6A6

Canada

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

Toronto, Ontario M5T 2S8

Canada

G.R.M.O. Inc.

Québec, Quebec G1V 3M7

Canada

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, Anhui 233004

China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality 100053

China

Peking University Third Hospital

Beijing, Beijing Municipality 100191

China

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Guangzhou First People's Hospital

Guangzhou, Guandong 519180

China

Shenzhen People's Hospital

Shenzhen, Guangdong 518020

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan 471000

China

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

Wuhan, Hubei 430022

China

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

Zhuzhou, Hunan 412007

China

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

Baotou Shi, Inner Mongolia 014010

China

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

Hangzhou, Jiangsu 215005

China

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

Nanjing, Jiangsu 210029

China

Affiliated Hospital of Nantong University

Nantong, Jiangsu 226001

China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu 225007

China

Jiujiang No.1 People's Hospital

Jiujiang Shi, Jiangxi 332000

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330008

China

Jiangxi Pingxiang People's Hospital

Pingxiang, Pingxiang Pingxiang

China

The 2nd Hospital of Xi'An Jiaotong University

Xi'an, Shan'xi 710004

China

Linyi People's Hospital

Linyi Shi, Shandong 276000

China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Pudong New District, Shanghai Municipality 200127

China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi 030001

China

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

Taiyuan, Shanxi 030605

China

West China Hospital of Sichuan University

Chengdu, Sichuan 610041

China

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

Chengdu, 610072

China

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

Guangzhou, 510630

China

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, 200052

China

Wenzhou Medical University (WMU) - The First Affiliated Hospital

Wenzhou, 325000

China

Clinique de l'Infirmerie Protestante

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

France

CHU Toulouse

Toulouse, Haute Garonne 31059

France

CHRU de Tours

Tours, Indre Et Loire 37044

France

CHU de Reims

Reims, Marne " 51100"

France

Hopital Nord

Saint-Etienne, 13015

France

Universitatsklinikum Leipzig

Leipzig, Saxony 4103

Germany

Private Practice - Dr. Maren Sieburg

Magdeburg, Saxony-Anhalt 39104

Germany

ISA - Interdisciplinary Study Association

Berlin, 10789

Germany

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg

Hamburg, 20095

Germany

Rheumazentrum Ruhrgebiet

Herne, 44649

Germany

Kojunkai Social Medical Corporation Daido Clinic

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

Japan

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602

Japan

Hokkaido University Hospital

Sapporo, Hokkaido 060-8648

Japan

Fukuoka University Hospital

Fukuoka, Hukuoka 814-0180

Japan

Kita-Harima Medical Center

Ono-shi, Hyōgo 675-1392

Japan

Mie University Hospital

Tsu, Mie, Mie-ken 514-8507

Japan

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi 983-8512

Japan

Sasebo Chuo Hospital

Sasebo-shi, Nagasaki 857-1195

Japan

Nippon Life Hospital

Nishi Ward, Osaka 550-0006

Japan

St. Luke's International Hospital

Chuo-ku, Tokyo 104-8560

Japan

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo 152-8902

Japan

Toho University Ohashi Medical Center

Meguro-ku, Tokyo 153-8515

Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo 160-0023

Japan

Kyorin University Hospital

Mitaka-shi, Tokyo-To 181-8611

Japan

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-090

Poland

Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland

Krakow, Lesser Poland Voivodeship 30-033

Poland

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

Wroclaw, Lower Silesian Voivodeship 50-244

Poland

dermMedica Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship 51-503

Poland

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship 81-338

Poland

Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland

Częstochowa, Silesian Voivodeship 42-217

Poland

Centrum Kliniczno Badawcze | Elblag, Poland

Elblag, Warmian-Masurian Voivodeship 82-300

Poland

Medyczne Centrum Hetmańska Piotr Leszczyński

Poznan, Wielkopolska 60-128

Poland

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

Poznan, Wielkopolska 61-731

Poland

Klinika Reuma Park

Warsaw, Wybierz Województwo 02-665

Poland

Zespol Poradni Specjalistycznych Reumed

Lublin, 20-607

Poland

Hospital Universitario Araba - Sede Hospital Txagorritxu

Vitoria-Gasteiz, Basque Country 1009

Spain

Hospital Universitario Marques de Valdecilla | Rheumatology Department

Santander, Cantabria 39008

Spain

Accellacare Alcobendas

Alcobendas, Madrid 28100

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320

Spain

Hospital Quirónsalud Sagrado Corazón

Seville, 41013

Spain

King's College Hospital

London, Greater London SE5 9RS

United Kingdom

Coventry and Warwickshire Partnership NHS Trust

Coventry, West Midlands CV2 2DX

United Kingdom

St Luke's Hospital - UK

Bradford, West Yorkshire BD5 0NA

United Kingdom

The Princess Alexandra Hospital NHS Trust

Harlow, CM20 1QX

United Kingdom

Oxford University Hospitals NHS Trust

Oxford, OX3 9RP

United Kingdom

Haywood Hospital

Stoke-on-Trent, ST6 7AG

United Kingdom

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP

United Kingdom