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

May 29, 2026 updated by: Takeda

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1088

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

  • Belgium
      • Brussels, Belgium, 1000
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
        • Contact:
        • Principal Investigator:
          • Clio Ribbens
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Recruiting
        • Université libre de Bruxelles
        • Contact:
        • Principal Investigator:
          • Joelle Margaux
    • Flanders
      • Ghent, Flanders, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Principal Investigator:
          • Filip Van Den Bosch
        • Contact:
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • ReumaClinic Genk
        • Contact:
        • Principal Investigator:
          • Johan Vanhoof
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical center Medconsult Pleven OOD
        • Principal Investigator:
          • Krasimira Tsoneva
        • Contact:
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • AES Partner Site -Plovdiv
        • Contact:
        • Principal Investigator:
          • Ivan Yakov
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Medical Center Artmed OOD | Plovdiv, Bulgaria
        • Principal Investigator:
          • Mariela Geneva-Popova
        • Contact:
      • Rousse, Bulgaria, 7002
        • Recruiting
        • Diagnostic- Consultative Center- 1- Ruse EOOD
        • Contact:
        • Principal Investigator:
          • Nadezhda Yordanova
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria
        • Contact:
        • Principal Investigator:
          • Elena Bischoff
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Medical Center Zara-Med EOOD
        • Contact:
        • Principal Investigator:
          • Hristo Vasilev
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1463
        • Recruiting
        • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
        • Principal Investigator:
          • Rasho Rashkov
        • Contact:
      • Sofia, Sofia-Grad, Bulgaria, 1784
        • Recruiting
        • Centre of Rheumatology St. Irina
        • Contact:
        • Principal Investigator:
          • Rodina Licheva
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia
        • Principal Investigator:
          • Boycho Oparanov
        • Contact:
  • Chile
      • Santiago, Chile, 8420383
        • Recruiting
        • Centro Internacional de Estudios Clínicos
        • Contact:
        • Principal Investigator:
          • Fernando Valenzuela Ahumada
      • Santiago, Chile, 8320000
        • Recruiting
        • Centro de Estudios Clinicos
        • Contact:
        • Principal Investigator:
          • Ivan Gonzalez
      • Santiago, Chile, 8320000
        • Recruiting
        • CTR Estudios
        • Contact:
        • Principal Investigator:
          • Luisa Andrea Donaire Romo
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500000
        • Recruiting
        • El Centro de Estudios Reumatologicos (CER)
        • Contact:
        • Principal Investigator:
          • Pedro Claudio Miranda Cabezas
      • Santiago, Santiago Metropolitan, Chile, 7640881
        • Recruiting
        • Clinica Dermacross S.A.
        • Contact:
        • Principal Investigator:
          • Claudia Paz De La Cruz Fernandez
  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • Clinical Hospital Centre Osijek
        • Contact:
        • Principal Investigator:
          • Jasminka Milas-Ahic
      • Rijeka, Croatia, 51000
        • Recruiting
        • Clinical Hospital Center Rijeka
        • Contact:
        • Principal Investigator:
          • Srdan Novak
      • Split, Croatia, 21000
        • Recruiting
        • University Hospital Centre Split
        • Contact:
        • Principal Investigator:
          • Mislav Radic
      • Zadar, Croatia, 23000
        • Recruiting
        • General Hospital Zadar
        • Contact:
        • Principal Investigator:
          • Zeljka Kardum
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Medicinski Centar Kuna and Peric
        • Contact:
        • Principal Investigator:
          • Porin Peric
  • Czechia
      • Pardubice, Czechia, 53002
        • Recruiting
        • Pratia Pardubice a.s.
        • Contact:
        • Principal Investigator:
          • Marcela Svobodova
    • Czech Rep
      • Brno, Czech Rep, Czechia, 63800
        • Recruiting
        • Revmatologie s.r.o. | Brno, Czech Republic
        • Principal Investigator:
          • Leona Prochazkova
        • Contact:
      • Hlučín, Czech Rep, Czechia, 92307
        • Recruiting
        • L.K.N. Arthrocentrum, s.r.o. - Revmatologicka
        • Principal Investigator:
          • Libor Novosad
        • Contact:
          • Site Contact
          • Phone Number: 420 595 044 402
        • Contact:
      • Prague, Czech Rep, Czechia, 150 00
        • Recruiting
        • Praglandia | Prague, Czech Republic
        • Principal Investigator:
          • Andrea Vocilkova
        • Contact:
      • Prague, Czech Rep, Czechia, 100 00
        • Recruiting
        • Clintrial s.r.o. | Prague, Czech Republic
        • Principal Investigator:
          • Vlasta Gollerova
        • Contact:
      • Uherské Hradiště, Czech Rep, Czechia, 68601
        • Recruiting
        • MEDICAL Plus s.r.o.
        • Principal Investigator:
          • Eva Dokoupilova
        • Contact:
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 702 00
    • NAP
      • Zlín, NAP, Czechia, 760 01
        • Recruiting
        • Pv Medical Services
        • Principal Investigator:
          • Petr Vitek
        • Contact:
    • Prague
      • Prague, Prague, Czechia, 12800
        • Recruiting
        • Revmatologicky ustav | Clinical Evaluation Department
        • Contact:
        • Principal Investigator:
          • Jakub Zavada
  • Estonia
      • Tallinn, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department
        • Principal Investigator:
          • Eve-Kai Raussi
        • Contact:
      • Tartu, Estonia, 50708
    • Harju
      • Tallinn, Harju, Estonia, 10117
        • Recruiting
        • Innomedica OU | Tallinn, Estonia
        • Contact:
        • Principal Investigator:
          • Sandra Meisalu
      • Tallinn, Harju, Estonia, 10128
        • Recruiting
        • Center for Clinical and Basic Research
        • Principal Investigator:
          • Ivo Valter
        • Contact:
    • Tartu
      • Tartu, Tartu, Estonia, 50106
        • Recruiting
        • Clinical Research Centre | Tartu, Estonia
        • Principal Investigator:
          • Airi Poder
        • Contact:
  • Germany
      • Berlin, Germany, 12161
        • Recruiting
        • Rheumatologische Schwerpunktpraxis | Berlin, Germany
        • Contact:
        • Principal Investigator:
          • Jan Brandt-Jurgens
      • Dresden, Germany, 01067
      • Hamburg, Germany, 20095
        • Recruiting
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
        • Principal Investigator:
          • Andrea Everding
        • Contact:
      • München, Germany, 81667
        • Recruiting
        • Medicover MVZ München Ost
        • Principal Investigator:
          • David Kofler
        • Contact:
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim
        • Principal Investigator:
          • Athanasios Tsianakas
        • Contact:
    • Mecklenburg-Vorpommern
      • Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
        • Recruiting
        • Rheumzentrum Prof.Dr.med.Gunther Neeck
        • Principal Investigator:
          • Gunther Neeck
        • Contact:
    • North Rhine-Westphalia
      • Ratingen, North Rhine-Westphalia, Germany, 40878
        • Recruiting
        • Rheumazentrum Ratingen-Studienambulanz
        • Principal Investigator:
          • Siegfried Wassenberg
        • Contact:
    • Saxony
  • Hungary
      • Budapest, Hungary, 1036
        • Recruiting
        • Qualiclinic | Budapest, Hungary
        • Principal Investigator:
          • Istvan Szombati
        • Contact:
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center
        • Contact:
        • Principal Investigator:
          • Judit Pulai
      • Veszprém, Hungary, 8200
        • Recruiting
        • Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary
        • Principal Investigator:
          • Edit Drescher
        • Contact:
    • Csongrad-Csanad
      • Hódmezővásárhely, Csongrad-Csanad, Hungary, 6800
        • Recruiting
        • Porcika Klinika
        • Principal Investigator:
          • Eva Balazs
        • Contact:
      • Szeged, Csongrad-Csanad, Hungary, 6720
        • Recruiting
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
        • Contact:
        • Principal Investigator:
          • Attila Balog
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Recruiting
        • CMed Rehabilitacios es Diagnosztikai Kozpont
        • Principal Investigator:
          • Tunde Varga
        • Contact:
  • Israel
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center | Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Jennifer (Guttman) Ben Shimol
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
        • Principal Investigator:
          • Yolanda Braun-Moscovici
      • Nahariya, Israel, 2210001
        • Recruiting
        • Galilee Medical Center | Rheumatology Unit
        • Contact:
        • Principal Investigator:
          • Mohammad E. Naffaa
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases
        • Principal Investigator:
          • Merav Lidar
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Elkayam Ori
    • Southern District
      • Ashdod, Southern District, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center
        • Contact:
        • Principal Investigator:
          • Yonatan Edel
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • Serena Guiducci
        • Contact:
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Principal Investigator:
          • Marta Mosca
        • Contact:
    • Ancona
      • Torrette, Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
        • Contact:
        • Principal Investigator:
          • Michele Maria Luchetti Gentiloni
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Not yet recruiting
        • Fondazione Ptv Policlinico Tor Vergata
        • Contact:
        • Principal Investigator:
          • Maria Sole Chimenti
      • Rome, Lazio, Italy, 168
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Recruiting
        • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
        • Contact:
        • Principal Investigator:
          • Ennio Giulio Favalli
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
        • Principal Investigator:
          • Lorenzo Dagna
        • Contact:
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • IRCCS Istituto Clinico Humanitas
        • Contact:
        • Principal Investigator:
          • Carlo Francesco Selmi
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Azienda Ospedale Università Padova
        • Contact:
        • Principal Investigator:
          • Roberta Ramonda
  • Latvia
      • Liepāja, Latvia, 3401
        • Recruiting
        • D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
        • Principal Investigator:
          • Daina Saulite-Kandevica
        • Contact:
          • Site Contact
          • Phone Number: 371 (0) 34-29509038
          • Email: dskap@inbox.lv
      • Riga, Latvia, LV-1005
        • Recruiting
        • ORTO Clinic | Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Anna Mihailova
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Office of Cesar F. Pacheco-Tena, MD
        • Principal Investigator:
          • Cesar Pacheco-Tena
        • Contact:
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21200
        • Recruiting
        • Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
        • Principal Investigator:
          • Francisco Fidencio Cons Molina
        • Contact:
    • Guadalajara
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Recruiting
        • Centro Integral en Reumatologia, S.A. de C.V.
        • Contact:
        • Principal Investigator:
          • Hilario Avila-Armengol
      • Guadalajara, Jalisco, Mexico, 44600
        • Recruiting
        • Private Practice - Dr. Delfina Villanueva Quintero
        • Principal Investigator:
          • Delfina Villanueva Quintero
        • Contact:
    • Mexico City
      • Gustavo Adolfo Madero, Mexico City, Mexico, 07760
        • Recruiting
        • Consultorio de Reumatologia
        • Principal Investigator:
          • Sandra Miriam Carrillo Vazquez
        • Contact:
      • Mexico City, Mexico City, Mexico, 06720
        • Not yet recruiting
        • HMG Hospital Coyoacan
        • Contact:
        • Principal Investigator:
          • Julio Casasola Vargas
      • Mexico City, Mexico City, Mexico, 11850
        • Recruiting
        • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
        • Contact:
        • Principal Investigator:
          • Fedra Irazoque-Palazuelos
    • Yucatán
      • Mérida, Yucatán, Mexico, 97133
        • Recruiting
        • Hospitales Star Medica
        • Principal Investigator:
          • Francisco Avila Zapata
        • Contact:
      • Mérida, Yucatán, Mexico, 97070
        • Recruiting
        • Kohler and Milstein Research Yucatan
        • Contact:
        • Principal Investigator:
          • J. Abraham Simon
  • New Zealand
    • Christchurch
      • Christchurch Central, Christchurch, New Zealand, 8013
        • Recruiting
        • CGM Research Trust
        • Contact:
        • Principal Investigator:
          • Nigel Gilchrist
    • North Island
      • Auckland, North Island, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials
        • Principal Investigator:
          • Mark Sapsford
        • Contact:
      • Auckland, North Island, New Zealand, 6022
        • Recruiting
        • North Shore Hospital
        • Principal Investigator:
          • Kristine Ng
        • Contact:
    • South Island
      • Nelson, South Island, New Zealand, 7010
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 8011
  • Poland
      • Lodz, Poland, 91-363
        • Recruiting
        • FutureMeds | Lodz Center - Lodz, Poland
        • Principal Investigator:
          • Katarzyna Bartnicka-Maslowska
        • Contact:
      • Lodz, Poland, 90-302
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia | Nowa Sol, Poland
        • Principal Investigator:
          • Malgorzata Miakisz
        • Contact:
      • Wroclaw, Poland, 53-673
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Mariusz Korkosz
        • Contact:
      • Krakow, Lesser Poland Voivodeship, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Principal Investigator:
          • Alicja Wloch
        • Contact:
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • Krakowskie Centrum Medyczne
        • Contact:
        • Principal Investigator:
          • Weronika Kleczynska-Szpakiewicz
    • Lower Silesian Voivodeship
      • Katowice, Lower Silesian Voivodeship, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Katowice - PRATIA
        • Contact:
        • Principal Investigator:
          • Tomasz Dziewit
    • Masovian Voivodeship
      • Sochaczew, Masovian Voivodeship, Poland, 96-500
        • Recruiting
        • RCMed | Sochaczew, Poland
        • Principal Investigator:
          • Monika Wronisz
        • Contact:
      • Warsaw, Masovian Voivodeship, Poland, 02-118
        • Recruiting
        • Rheuma Medicus | Warsaw, Poland
        • Contact:
        • Principal Investigator:
          • Rell-Bakalarska Maria
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by Pratia
        • Contact:
        • Principal Investigator:
          • Robert Rupinski
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic
        • Principal Investigator:
          • Brygida Kwiatkowska
        • Contact:
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
        • Contact:
        • Principal Investigator:
          • Jaworski Janusz
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Recruiting
        • ETG Warszawa Sp. z o.o.
        • Principal Investigator:
          • Anna Rowinska-Osuch
        • Contact:
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-819
        • Recruiting
        • Twoja Przychodnia Opolskie Centrum Medyczne
        • Principal Investigator:
          • Grazyna Jaworska-Gorna
        • Contact:
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-077
        • Recruiting
        • INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland
        • Contact:
        • Principal Investigator:
          • Piotr Klimiuk
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Recruiting
        • Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
        • Principal Investigator:
          • Artur Racewicz
        • Contact:
      • Bialystok, Podlaskie Voivodeship, Poland, 15-077
        • Recruiting
        • Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
        • Principal Investigator:
          • Izabela Domyslawska
        • Contact:
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Poland, 41-902
        • Recruiting
        • Bif-Med s.c. NZOZ
        • Principal Investigator:
          • Hanna Mastalerz
        • Contact:
      • Torun, Silesian Voivodeship, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun
        • Principal Investigator:
          • Slawomir Jeka
        • Contact:
          • Site Contact
          • Phone Number: 48 606453300
          • Email: s.jeka@wp.pl
    • Warmian-Masurian Voivodeship
      • Dąbrówka, Warmian-Masurian Voivodeship, Poland, 62-069
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Recruiting
        • Ambulatorium sp. z o.o.
        • Principal Investigator:
          • Anna Bazela-Ostromecka
        • Contact:
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-117
        • Recruiting
        • Etyka Osrodek Badan Klinicznych | Olsztyn, Poland
        • Contact:
        • Principal Investigator:
          • Magdalena Krajewska-Wlodarczyk
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60-324
        • Recruiting
        • Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
        • Principal Investigator:
          • Agata Wytyk-Nowak
        • Contact:
    • Wlkp
      • Poznan, Wlkp, Poland, 60-446
        • Recruiting
        • Reumedika | Poznan, Poland
        • Principal Investigator:
          • Wieslawa Porawska
        • Contact:
    • Woj. Wielkopolskie
      • Poznan, Woj. Wielkopolskie, Poland, 61-397
        • Recruiting
        • Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland
        • Principal Investigator:
          • Pawel Hrycaj
        • Contact:
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Hospital Garcia de Orta
        • Contact:
        • Principal Investigator:
          • Maria Jose Parreira dos Santos
      • Lisbon, Portugal, 1050-034
        • Recruiting
        • Instituto Portugues de Reumatologia
        • Contact:
        • Principal Investigator:
          • Luis Miguel da Cunha Cristovao Botelho de Miranda
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Elsa Vieira de Sousa
    • Barcelona
      • Coimbra, Barcelona, Portugal, 3004-561
        • Recruiting
        • Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
        • Contact:
        • Principal Investigator:
          • Mary Lucy Marques
      • Ponte de Lima, Barcelona, Portugal, 4990-041
        • Recruiting
        • Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
        • Contact:
        • Principal Investigator:
          • Jose Antonio Tavares Da Costa
    • New Mexico
      • Vila Nova de Gaia, New Mexico, Portugal, 4434-502
        • Recruiting
        • Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
        • Contact:
        • Principal Investigator:
          • Diogo Fonseca
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Centro Reumatologico de Caguas | Caguas, PR
        • Principal Investigator:
          • Amarilis Perez De Jesus
        • Contact:
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • GCM Medical Group, PSC | San Juan, PR
        • Principal Investigator:
          • Karina Vila-Rivera
        • Contact:
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Chang-Keun Lee
      • Seoul, South Korea, 2447
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
        • Principal Investigator:
          • Yeon-Ah Lee
      • Seoul, South Korea, 07061
        • Recruiting
        • SMG - SNU Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Kichul Shin
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University of Korea
        • Contact:
        • Principal Investigator:
          • Yune-Jung Park
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16499
        • Recruiting
        • Ajou University Hospital | Clinical Trial Center
        • Principal Investigator:
          • Chang-Hee Suh
        • Contact:
  • Spain
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
        • Principal Investigator:
          • Antonio Fernandez-Nebro
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Jose Perez Venegas
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Isabel de la Morena Barrio
    • Badajoz
      • Mérida, Badajoz, Spain, 06006
        • Recruiting
        • Hospital Universitario de Badajoz
        • Contact:
        • Principal Investigator:
          • Eugenio Chamizo-Carmona
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
        • Contact:
        • Principal Investigator:
          • Mireia Moreno Martinez-Losa
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department
        • Contact:
        • Principal Investigator:
          • ANTONIO MERA-VARELA
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Recruiting
        • Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Chien-Sheng Wu
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
        • Principal Investigator:
          • James Cheng-Chung Wei
      • Tainan, Taiwan, 710
        • Recruiting
        • Chi Mei Medical Center
        • Contact:
        • Principal Investigator:
          • Hung-An Chen
    • Tainan City
      • Tainan, Tainan City, Taiwan, 701
        • Recruiting
        • National Cheng Kung University
        • Contact:
        • Principal Investigator:
          • Meng-Yu Weng
    • Taipei City
      • Zhong Zheng Qu, Taipei City, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Tsen-Fang Tsai
        • Contact:
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
        • Principal Investigator:
          • Nehad Soloman
        • Contact:
      • Phoenix, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
        • Principal Investigator:
          • Andrew Sharobeem
        • Contact:
    • California
      • Fountain Valley, California, United States, 92708
      • La Mesa, California, United States, 91942
        • Recruiting
        • Purushotham & Akther Kotha MD
        • Principal Investigator:
          • Roshan Kotha
        • Contact:
      • La Mesa, California, United States, 91942
        • Recruiting
        • Triwest Research Associates Llc
        • Principal Investigator:
          • Arthur Ray Mabaquiao
        • Contact:
      • Thousand Oaks, California, United States, 91360-3967
        • Recruiting
        • The Cohen Medical Centers
        • Principal Investigator:
          • Shariar Cohen-Gadol
        • Contact:
      • Tujunga, California, United States, 91042
        • Recruiting
        • Foothill Arthritis Clinic
        • Principal Investigator:
          • DAN LA
        • Contact:
      • Whittier, California, United States, 90602-1005
        • Recruiting
        • Medvin Clinical Research
        • Principal Investigator:
          • Tien-I Karleen Su
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic | Denver, CO
        • Principal Investigator:
          • Christopher Antolini
        • Contact:
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Arthritis & Rheumatic Disease Specialties (AARDS)
        • Principal Investigator:
          • Norman Gaylis
        • Contact:
      • Boca Raton, Florida, United States, 33486-1390
        • Recruiting
        • RASF- Clinical Research Center
        • Principal Investigator:
          • Shawn Baca
        • Contact:
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida | Clearwater, FL
        • Principal Investigator:
          • Robert Levin
        • Contact:
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • GNP Research, LLC | Hollywood, FL
        • Principal Investigator:
          • Mark Jaffe
        • Contact:
      • Coral Gables, Florida, United States, 33134-3901
        • Recruiting
        • Driven Research LLC
        • Principal Investigator:
          • Javier Alonso-Llamazares
        • Contact:
      • Davie, Florida, United States, 33024
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
        • Principal Investigator:
          • Carlos Sesin
        • Contact:
      • Miami, Florida, United States, 33143
        • Recruiting
        • Bioresearch Partners
        • Contact:
        • Principal Investigator:
          • Olga Kromo
      • Orlando, Florida, United States, 32819
        • Recruiting
        • HMD Research LLC
        • Principal Investigator:
          • Marvin Heuer
        • Contact:
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Millennium Research | Ormond Beach, FL
        • Contact:
        • Principal Investigator:
          • Michael Kohen
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development | Plantation, FL
        • Principal Investigator:
          • Guillermo Valenzuela
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Arthritis Research Center
        • Principal Investigator:
          • Jesse Boodoo
        • Contact:
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates, Inc.
        • Contact:
        • Principal Investigator:
          • Laurie Ramrattan
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida | Tampa, FL
        • Principal Investigator:
          • John Carter
        • Contact:
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Marietta Rheumatology Associates
        • Principal Investigator:
          • Roel Querubin
        • Contact:
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Recruiting
        • GSCP/CIS
        • Principal Investigator:
          • Cory Conniff
        • Contact:
      • Schaumburg, Illinois, United States, 60195
        • Recruiting
        • Greater Chicago Specialty Physicians LLC/CIS
        • Principal Investigator:
          • Kamran Chaudhary
        • Contact:
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Accurate Clinical Research, Inc. | Lake Charles
        • Principal Investigator:
          • Enrique Mendez
        • Contact:
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein & Associates, M.D., P.A.
        • Principal Investigator:
          • Mary Howell
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Health System-Rheumatology Department
        • Principal Investigator:
          • Alireza Meysami
        • Contact:
      • Grand Blanc, Michigan, United States, 48439-2451
        • Recruiting
        • Michigan Rheumatology Group, P.C. - Grand Blanc Office
        • Principal Investigator:
          • Ali Karrar
        • Contact:
      • Howell, Michigan, United States, 48843
      • Lansing, Michigan, United States, 48911-4285
        • Recruiting
        • June DO, PC Private Practice - Dr. Justus Fiechtner
        • Principal Investigator:
          • Joshua June
        • Contact:
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan
        • Principal Investigator:
          • Andrew Sulich
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63119
        • Recruiting
        • Saint Louis Rheumatology
        • Principal Investigator:
          • Chad Ronholm
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102-1710
        • Recruiting
        • Albuquerque Center for Rheumatology PC
        • Principal Investigator:
          • Leroy Pacheco
        • Contact:
      • Santa Fe, New Mexico, United States, 87505-1102
        • Recruiting
        • Santa Fe Rheumatology
        • Principal Investigator:
          • Hillary Norton
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department
        • Principal Investigator:
          • David Goddard
        • Contact:
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Recruiting
        • Accellacare of Hickory
        • Contact:
        • Principal Investigator:
          • Ronald Caldwell
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
        • Principal Investigator:
          • Marina Magrey
        • Contact:
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Principal Investigator:
          • Isam Diab
        • Contact:
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610-3206
        • Recruiting
        • PA Regional Center for Arthritis and Osteoporosis Research
        • Principal Investigator:
          • Gregory Emkey
        • Contact:
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Principal Investigator:
          • Jacob Aelion
        • Contact:
    • Texas
      • Baytown, Texas, United States, 77521
      • Houston, Texas, United States, 77089
      • Houston, Texas, United States, 77024
        • Recruiting
        • Novel Research | Bellaire Location
        • Contact:
        • Principal Investigator:
          • Abigail Neiman
      • Houston, Texas, United States, 77090
        • Recruiting
        • Introscience Research | Northwest Houston Arthritis Center - Houston, TX
        • Contact:
        • Principal Investigator:
          • Adnan Peer
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • West Texas Clinical Research
        • Principal Investigator:
          • Jitendra Vasandani
        • Contact:
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • Southwest Rheumatology Research, LLC | Mesquite, TX
        • Principal Investigator:
          • Atul Singhal
        • Contact:
      • Plano, Texas, United States, 75075
        • Recruiting
        • Clinical Investigations of Texas
        • Contact:
        • Principal Investigator:
          • Fehmida Zahabi
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Arthritis Northwest, PLLC | Spokane, WA
        • Contact:
        • Principal Investigator:
          • Michael Coan
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Not yet recruiting
        • Medical College of Wisconsin | Department of Medicine - Rheumatology Division
        • Contact:
        • Principal Investigator:
          • Shikha Singla

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). 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).

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 over-encapsulated 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 over-encapsulated 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 over-encapsulated tablets.
Other Names:
  • NDI-034858
  • TAK- 279
Drug: Placebo
Zasocitinib or active comparator matching placebo.
Active Comparator: Active Comparator Dose C
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Drug: Active Comparator
Active comparator capsule.

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 ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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 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 of at Week 16 for zasocitinib Dose A and B compared to active comparator 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 compared to Active Comparator
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% BSA) for zasocitinib Dose A compared to active comparator 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 Active Comparator
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 active comparator will be reported.
At Week 16
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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 active comparator will be reported.
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 Active Comparator
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 active comparator 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 Active Comparator
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 active comparator 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 Active Comparator
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 active comparator will be reported.
Baseline, at Week 16
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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 active comparator will be reported.
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 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
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 SPARCC Enthesis Index = 0 through Week 16 for zasocitinib Dose A and B compared to placebo will be reported
Baseline up to Week 16

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 3, 2025

Primary Completion (Estimated)

May 18, 2027

Study Completion (Estimated)

January 28, 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)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-279-PsA-3001
  • 2024-513111-27-00 (Ctis)

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.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Zasocitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe