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NCT06671483PHASE3Recruiting

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Takeda

Start Date

3/3/2025

Completion Date

1/28/2028

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 who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, 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). In South Korea, the age requirement for adult participants is \>=19 years of age. 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). 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

Active Comparator

DRUG

Placebo

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Conditions

Psoriatic Arthritis

Locations

AARR- Chandler AZ

Chandler, Arizona 85225

United States

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Phoenix, Arizona 85032

United States

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Phoenix, Arizona 85032

United States

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Phoenix, Arizona 85306

United States

First OC Dermatology Research Inc.

Fountain Valley, California 92708

United States

Purushotham & Akther Kotha MD

La Mesa, California 91942

United States

Triwest Research Associates LLC

La Mesa, California 91942

United States

The Cohen Medical Centers

Thousand Oaks, California 91360-3967

United States

Foothill Arthritis Clinic

Tujunga, California 91042

United States

Medvin Clinical Research

Whittier, California 90602-1005

United States

Denver Arthritis Clinic | Denver, CO

Denver, Colorado 80230

United States

Arthritis & Rheumatic Disease Specialties (AARDS)

Aventura, Florida 33180

United States

RASF- Clinical Research Center

Boca Raton, Florida 33486-1390

United States

Clinical Research of West Florida | Clearwater, FL

Clearwater, Florida 33765

United States

GNP Research, LLC | Hollywood, FL

Cooper City, Florida 33024

United States

Driven Research LLC

Coral Gables, Florida 33134-3901

United States

Tectum Medical Research

Davie, Florida 33024

United States

Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research

Hialeah, Florida 33016

United States

Bioresearch Partners

Miami, Florida 33143

United States

HMD Research LLC

Orlando, Florida 32819

United States

Millennium Research | Ormond Beach, FL

Ormond Beach, Florida 32174

United States

IRIS Research and Development | Plantation, FL

Plantation, Florida 33324

United States

Sarasota Arthritis Research Center

Sarasota, Florida 34239

United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida 33321

United States

Clinical Research of West Florida | Tampa, FL

Tampa, Florida 33606

United States

Marietta Rheumatology Associates

Marietta, Georgia 30060

United States

GSCP/CIS

Orland Park, Illinois 60467

United States

Greater Chicago Specialty Physicians LLC/CIS

Schaumburg, Illinois 60195

United States

Accurate Clinical Research, Inc. | Lake Charles

Lake Charles, Louisiana 70605

United States

Klein & Associates, M.D., P.A.

Hagerstown, Maryland 21740

United States

Henry Ford Health System-Rheumatology Department

Detroit, Michigan 48202

United States

Michigan Rheumatology Group, P.C. - Grand Blanc Office

Grand Blanc, Michigan 48439-2451

United States

Ash Research Clinic - Howell

Howell, Michigan 48843

United States

June DO, PC Private Practice - Dr. Justus Fiechtner

Lansing, Michigan 48911-4285

United States

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan 48081

United States

Saint Louis Rheumatology

St Louis, Missouri 63119

United States

Albuquerque Center for Rheumatology PC

Albuquerque, New Mexico 87102-1710

United States

Santa Fe Rheumatology

Santa Fe, New Mexico 87505-1102

United States

NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department

Brooklyn, New York 11201

United States

Accellacare of Hickory

Hickory, North Carolina 28602

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

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania 19610-3206

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Accurate Clinical Research

Baytown, Texas 77521

United States

Novel Research | Bellaire Location

Houston, Texas 77024

United States

Novel Research | Bellaire Location

Houston, Texas 77024

United States

Accurate Clinical Research

Houston, Texas 77089

United States

Introscience Research | Northwest Houston Arthritis Center - Houston, TX

Houston, Texas 77090

United States

West Texas Clinical Research

Lubbock, Texas 79424

United States

Southwest Rheumatology Research, LLC | Mesquite, TX

Mesquite, Texas 75150

United States

Clinical Investigations of Texas

Plano, Texas 75075

United States

Arthritis Northwest, PLLC | Spokane, WA

Spokane, Washington 99204

United States

Université Libre de Bruxelles

Anderlecht, Brussels Capital 1070

Belgium

University Hospital Ghent

Ghent, Flanders 9000

Belgium

ReumaClinic Genk

Genk, Limburg 3600

Belgium

St Pierre Brussels

Brussels, 1000

Belgium

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Diagnostic Consultative Centre - Focus-5 - LZIP EOOD

Sofia, Sofia-Grad 1463

Bulgaria

Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia

Sofia, Sofia-Grad 1606

Bulgaria

Centre of Rheumatology St. Irina

Sofia, Sofia-Grad 1784

Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, 5800

Bulgaria

AES Partner Site -Plovdiv

Plovdiv, 4000

Bulgaria

Medical Center Artmed OOD | Plovdiv, Bulgaria

Plovdiv, 4000

Bulgaria

Diagnostic- Consultative Center- 1- Ruse EOOD

Rousse, 7002

Bulgaria

Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria

Stara Zagora, 6000

Bulgaria

Medical Center Zara-Med EOOD

Stara Zagora, 6000

Bulgaria

El Centro de Estudios Reumatologicos (CER)

Providencia, Santiago Metropolitan 7500000

Chile

Clinica Dermacross S.A.

Santiago, Santiago Metropolitan 7640881

Chile

Centro de Estudios Clinicos

Santiago, 8320000

Chile

CTR Estudios

Santiago, 8320000

Chile

Centro Internacional de Estudios Clínicos

Santiago, 8420383

Chile

Medicinski Centar Kuna and Peric

Zagreb, City of Zagreb 10000

Croatia

Clinical Hospital Centre Osijek

Osijek, 31000

Croatia

Clinical Hospital Center Rijeka

Rijeka, 51000

Croatia

University Hospital Centre Split

Split, 21000

Croatia

General Hospital Zadar

Zadar, 23000

Croatia

Revmatologie s.r.o. | Brno, Czech Republic

Brno, Czech Rep 63800

Czechia

L.K.N. Arthrocentrum, s.r.o. - Revmatologicka

Hlučín, Czech Rep 92307

Czechia

Clintrial s.r.o. | Prague, Czech Republic

Prague, Czech Rep 100 00

Czechia

Praglandia | Prague, Czech Republic

Prague, Czech Rep 150 00

Czechia

MEDICAL Plus s.r.o.

Uherské Hradiště, Czech Rep 68601

Czechia

CCR Ostrava

Ostrava, Moravian-Silesian Region 702 00

Czechia

Pv Medical Services

Zlín, NAP 760 01

Czechia

Revmatologicky ustav | Clinical Evaluation Department

Prague, Prague 12800

Czechia

Pratia Pardubice a.s.

Pardubice, 53002

Czechia

Innomedica OU | Tallinn, Estonia

Tallinn, Harju 10117

Estonia

Center for Clinical and Basic Research

Tallinn, Harju 10128

Estonia

Clinical Research Centre | Tartu, Estonia

Tartu, Tartu 50106

Estonia

North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department

Tallinn, 13419

Estonia

MediTrials OÜ

Tartu, 50708

Estonia

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony 48455

Germany

Rheumzentrum Prof.Dr.med.Gunther Neeck

Bad Doberan, Mecklenburg-Vorpommern 18209

Germany

Rheumazentrum Ratingen-Studienambulanz

Ratingen, North Rhine-Westphalia 40878

Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony 4103

Germany

Rheumatologische Schwerpunktpraxis | Berlin, Germany

Berlin, 12161

Germany

Städtisches Klinikum Dresden

Dresden, 01067

Germany

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg

Hamburg, 20095

Germany

Medicover MVZ München Ost

München, 81667

Germany

Porcika Klinika

Hódmezővásárhely, Csongrad-Csanad 6800

Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrad-Csanad 6720

Hungary

CMed Rehabilitacios es Diagnosztikai Kozpont

Székesfehérvár, Fejér 8000

Hungary

Qualiclinic | Budapest, Hungary

Budapest, 1036

Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center

Székesfehérvár, 8000

Hungary

Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary

Veszprém, 8200

Hungary

Assuta Ashdod Medical Center

Ashdod, Southern District 7747629

Israel

Barzilai Medical Center | Rheumatology Department

Ashkelon, 7830604

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Galilee Medical Center | Rheumatology Unit

Nahariya, 2210001

Israel

The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases

Ramat Gan, 5265601

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

Torrette, Ancona 60126

Italy

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio 00133

Italy

Policlinico Agostino Gemelli, UOC Reumatology

Rome, Lazio 168

Italy

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, Lombardy 20122

Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Lombardy 20132

Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Milano 20089

Italy

Azienda Ospedale Università Padova

Padova, Veneto 35128

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia

Liepāja, 3401

Latvia

ORTO Clinic | Rheumatology Department

Riga, LV-1005

Latvia

Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)

Mexicali, Estado de Baja California 21200

Mexico

iBiomed Guadalajara

Zapopan, Guadalajara 44160

Mexico

Centro Integral en Reumatologia, S.A. de C.V.

Guadalajara, Jalisco 44160

Mexico

Private Practice - Dr. Delfina Villanueva Quintero

Guadalajara, Jalisco 44600

Mexico

Consultorio de Reumatologia

Gustavo Adolfo Madero, Mexico City 07760

Mexico

HMG Hospital Coyoacan

Mexico City, Mexico City 06720

Mexico

CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

Mexico City, Mexico City 11850

Mexico

Kohler and Milstein Research Yucatan

Mérida, Yucatán 97070

Mexico

Hospitales Star Medica

Mérida, Yucatán 97133

Mexico

Office of Cesar F. Pacheco-Tena, MD

Chihuahua City, 31000

Mexico

CGM Research Trust

Christchurch Central, Christchurch 8013

New Zealand

Aotearoa Clinical Trials

Auckland, North Island 2025

New Zealand

North Shore Hospital

Auckland, North Island 6022

New Zealand

Porter Rheumatology Ltd

Nelson, South Island 7010

New Zealand

Waikato Hospital

Hamilton, Waikato Region 8011

New Zealand

Pratia Poznań

Poznan, Greater Poland Voivodeship 60-192

Poland

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship 30-363

Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship 30-727

Poland

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship 31-501

Poland

Centrum Medyczne Katowice - PRATIA

Katowice, Lower Silesian Voivodeship 40-081

Poland

RCMed | Sochaczew, Poland

Sochaczew, Masovian Voivodeship 96-500

Poland

Rheuma Medicus | Warsaw, Poland

Warsaw, Masovian Voivodeship 02-118

Poland

MTZ Clinical Research Powered by PRATIA

Warsaw, Masovian Voivodeship 02-172

Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic

Warsaw, Masovian Voivodeship 02-637

Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship 02-665

Poland

ETG Warszawa Sp. z o.o.

Warsaw, Masovian Voivodeship 02-677

Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, Opole Voivodeship 45-819

Poland

INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland

Bialystok, Podlaskie Voivodeship 15-077

Poland

Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, Podlaskie Voivodeship 15-077

Poland

Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik

Bialystok, Podlaskie Voivodeship 15-351

Poland

Bif-Med s.c. NZOZ

Bytom, Silesian Voivodeship 41-902

Poland

MICS Centrum Medyczne Torun

Torun, Silesian Voivodeship 87-100

Poland

UNICA CR sp. z.o. o.

Dąbrówka, Warmian-Masurian Voivodeship 62-069

Poland

Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship 82-300

Poland

Etyka Osrodek Badan Klinicznych | Olsztyn, Poland

Olsztyn, Warmian-Masurian Voivodeship 10-117

Poland

Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.

Poznan, Wielkopolska 60-324

Poland

Reumedika | Poznan, Poland

Poznan, Wlkp 60-446

Poland

Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland

Poznan, Woj. Wielkopolskie 61-397

Poland

Santa Familia PTG Lodz | Lodz, Poland

Lodz, 90-302

Poland

FutureMeds | Lodz Center - Lodz, Poland

Lodz, 91-363

Poland

Twoja Przychodnia | Nowa Sol, Poland

Nowa Sól, 67-100

Poland

FutureMeds Wroclaw

Wroclaw, 53-673

Poland

Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra

Coimbra, Barcelona 3004-561

Portugal

Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho

Ponte de Lima, Barcelona 4990-041

Portugal

Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

Vila Nova de Gaia, New Mexico 4434-502

Portugal

Hospital Garcia de Orta

Almada, 2805-267

Portugal

Instituto Portugues de Reumatologia

Lisbon, 1050-034

Portugal

Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department

Lisbon, 1649-035

Portugal

Centro Reumatologico de Caguas | Caguas, PR

Caguas, 00725

Puerto Rico

GCM Medical Group, PSC | San Juan, PR

San Juan, 00917

Puerto Rico

The Catholic University of Korea

Suwon, Gyeonggi-do 16247

South Korea

Ajou University Hospital | Clinical Trial Center

Suwon, Gyeonggido 16499

South Korea

Asan Medical Center

Seoul, 05505

South Korea

SMG - SNU Boramae Medical Center

Seoul, 07061

South Korea

Kyung Hee University Hospital

Seoul, 2447

South Korea

Hospital Universitario de Badajoz

Mérida, Badajoz 06006

Spain

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, Barcelona 08208

Spain

Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department

Santiago de Compostela, Galicia 15706

Spain

Hospital Regional Universitario de Malaga

Málaga, 29010

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

National Cheng Kung University

Tainan, Tainan City 701

Taiwan

National Taiwan University Hospital

Zhong Zheng Qu, Taipei City 100

Taiwan

Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department

New Taipei City, 220

Taiwan

Chung Shan Medical University Hospital

Taichung, 40201

Taiwan

Chi Mei Medical Center

Tainan, 710

Taiwan