Psoriatic ArthritisPhase 3NCT06671483
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
A Phase 3 study testing Zasocitinib and Active Comparator in people with Psoriatic Arthritis, run by Takeda at 188 sites in 20 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Zasocitinib and Active Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,088 participants
- Where
- 188 sitesin 20 countries
- Study dates
- 3 Mar 2025to 28 Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:
- 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:
- The participant has a diagnosis of PsA.
- The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
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- The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
- The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
- Medications for PsA:
- The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union [EU]/ European Economic Area [EEA]), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
Who cannot join
- PsA and PsO:
- 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.
- 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).
Trial locations and contacts
188 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
188 sites in 20 countries
United States53 sites, 48 recruiting
- Recruiting
Albuquerque Center for Rheumatology PC
Albuquerque, New Mexico, 87102-1710
Site Contact, 505-242-6190, leroyp@abqrheum.net
Leroy Pacheco
- Recruiting
Arthritis & Rheumatic Disease Specialties (AARDS)
Aventura, Florida, 33180
Site Contact, 305-652-6676, drnbg@rheum.com
Norman Gaylis
- Recruiting
Accurate Clinical Research
Baytown, Texas, 77521
Site Contact, 832-705-7839, snajammd@accurateclinicalresearch.com
Sabeen Najam
- Recruiting
Novel Research | Bellaire Location
Bellaire, Texas, 77024
Site Contact, 832-757-8490, neiman@novelresearch.net
Abigail Neiman
- Recruiting
Novel Research | Bellaire Location
Bellaire, Texas, 77024
Site Contact, 832-400-2262, wajeeha@novelresearch.net
Wajeeha Yousaf
- Recruiting
RASF- Clinical Research Center
Boca Raton, Florida, 33486-1390
Site Contact, 5651-361-6547, sbb61@aol.com
Shawn Baca
- Recruiting
NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department
Brooklyn, New York, 11201
Site Contact, 347-390-7798, davidgoddardpi@gmail.com
David Goddard
- Recruiting
AARR- Chandler AZ
Chandler, Arizona, 85225
Site Contact, 480-443-8400, al-khoudari.research@azarthritis.com
Amer Al-Khoudari
- Recruiting
Clinical Research of West Florida | Clearwater, FL
Clearwater, Florida, 33765
Site Contact, 727-466-0078, rlevin@crwf.com
Robert Levin
- Recruiting
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
Cleveland, Ohio, 44106
Site, 216-286-1246, marina.magrey@uhhospitals.org
Marina Magrey
- Recruiting
GNP Research, LLC | Hollywood, FL
Cooper City, Florida, 33024
Site Contact, 754-248-3589, mjaffe@gnpresearch.com
Mark Jaffe
- Completed
Driven Research LLC
Coral Gables, Florida, 33134-3901
- Recruiting
Tectum Medical Research
Davie, Florida, 33024
Site Contact, 954-704-1050, Lilliam.miranda@tectumresearch.com
Lilliam Miranda
- Recruiting
Denver Arthritis Clinic | Denver, CO
Denver, Colorado, 80230
Site Contact, 303-394-2828 ext. 169, rantolini@dacdenver.com
Christopher Antolini
- Withdrawn
Henry Ford Health System-Rheumatology Department
Detroit, Michigan, 48202
- Recruiting
First OC Dermatology Research Inc.
Fountain Valley, California, 92708
Site Contact, 714-531-2966, vivian.laquer@firstocdermresearch.com
Vivian Laquer
- Recruiting
Michigan Rheumatology Group, P.C. - Grand Blanc Office
Grand Blanc, Michigan, 48439-2451
Site Contact, 810-694-0082, akarrar@aamrc.net
Ali Karrar
- Recruiting
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740
Site Contact, 301-724-4337, mhowell@rheumdocs.com
Mary Howell
- Recruiting
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, 33016
Site Contact, 305-456-9062, csesin1979@aol.com
Carlos Sesin
- Recruiting
Accellacare of Hickory
Hickory, North Carolina, 28602
Site Contact, 828-345-5060, rdc3s@yahoo.com
Ronald Caldwell
- Recruiting
Accurate Clinical Research
Houston, Texas, 77089
Site Contact, 281-240-1045, pwallermd@accurateclinicalresearch.com
Philip Waller
- Recruiting
Introscience Research | Northwest Houston Arthritis Center - Houston, TX
Houston, Texas, 77090
Site Contact, 832-834-5627, adnan@novelresearch.net
Adnan Peer
- Recruiting
Ash Research Clinic - Howell
Howell, Michigan, 48843
Site Contact, mir.asghar@ashresearchclinic.com
Mir M Asghar
- Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
Site Contact, 731-633-0145, aresearch@arthritisclinic.org
Jacob Aelion
- Recruiting
Purushotham & Akther Kotha MD
La Mesa, California, 91942
Site Contact, 619-229-1995 ext. 208, roshankotha@gmail.com
Roshan Kotha
- Recruiting
Triwest Research Associates LLC
La Mesa, California, 91942
Site Contact, 619-334-4735, drmabaquiao@triwestresearch.com
Arthur Ray Mabaquiao
- Recruiting
Accurate Clinical Research, Inc. | Lake Charles
Lake Charles, Louisiana, 70605
Site Contact, 337-312-8617, emendezmd@accurateclinicalresearch.com
Enrique Mendez
- Recruiting
June DO, PC Private Practice - Dr. Justus Fiechtner
Lansing, Michigan, 48911-4285
Site Contact, 517-272-9727, joshua.june@glcor.com
Joshua June
- Recruiting
West Texas Clinical Research
Lubbock, Texas, 79424
Site Contact, 806-993-1040, jitendra.vasandani@yahoo.com
Jitendra Vasandani
- Recruiting
Marietta Rheumatology Associates
Marietta, Georgia, 30060
Site Contact, 770-372-3962, rquerubin@csi-research.com
Roel Querubin
- Recruiting
Southwest Rheumatology Research, LLC | Mesquite, TX
Mesquite, Texas, 75150
Site Contact, 972-288-2600, asinghal@swrr.net
Atul Singhal
- Recruiting
Bioresearch Partners
Miami, Florida, 33143
Site Contact, 833-489-4968, okromomd@bioresearchpartner.com
Olga Kromo
- Recruiting
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Site Contact, 440-826-0742, idiabmd@gmail.com
Isam Diab
- Recruiting
GSCP/CIS
Orland Park, Illinois, 60467
Site Contact, 847-599-2492, cconniff@cisresearch.com
Cory Conniff
- Completed
HMD Research LLC
Orlando, Florida, 32819
- Recruiting
Millennium Research | Ormond Beach, FL
Ormond Beach, Florida, 32174
Site Contact, 386-672-1985, drkohen1@gmail.com
Michael Kohen
- Recruiting
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85032
Site Contact, 480-443-8400, chohan.research@azarthritis.com
Saima Chohan
- Recruiting
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85032
Site Contact, 602-386-4972, soloman.research@azarthritis.com
Nehad Soloman
- Completed
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85306
- Recruiting
Clinical Investigations of Texas
Plano, Texas, 75075
Site Contact, 972-599-1530, Fehmida.zahabi@citplano.com
Fehmida Zahabi
- Recruiting
IRIS Research and Development | Plantation, FL
Plantation, Florida, 33324
Site Contact, 954-476-2338, drvalenzuela@irisrheumatology.com
Guillermo Valenzuela
- Recruiting
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, 48081
Site Contact, 586-598-3329 ext. 201, asulich@msn.com
Andrew Sulich
- Recruiting
Santa Fe Rheumatology
Santa Fe, New Mexico, 87505-1102
Site Contact, 505-988-7568, drnorton@inspiresantafe.com
Hillary Norton
- Recruiting
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
Site Contact, 941-365-0770, jboodoo@arthritiscenters.net
Jesse Boodoo
- Recruiting
Greater Chicago Specialty Physicians LLC/CIS
Schaumburg, Illinois, 60195
Site Contact, 847-599-2492, kchaudhary@cisresearch.com
Kamran Chaudhary
- Recruiting
Arthritis Northwest, PLLC | Spokane, WA
Spokane, Washington, 99204
Site Contact, 509-838-6500, tcone@arthritisnw.com
Michael Coan
- Recruiting
Saint Louis Rheumatology
St Louis, Missouri, 63119
Site Contact, 314-646-0688, cronholm@stlrheum.com
Chad Ronholm
- Recruiting
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321
Site Contact, 954-724-5560, wbral.ramrattan@gmail.com
Laurie Ramrattan
- Recruiting
Clinical Research of West Florida | Tampa, FL
Tampa, Florida, 33606
Site Contact, 813-870-1292, jcarter@crwf.com
John Carter
- Recruiting
The Cohen Medical Centers
Thousand Oaks, California, 91360-3967
Site Contact, 805-728-0050, Scohen@sclamanagement.com
Shariar Cohen-Gadol
- Recruiting
Foothill Arthritis Clinic
Tujunga, California, 91042
Site Contact, 213-281-5146, vipul@medvinresearch.com
Dan La
- Completed
Medvin Clinical Research
Whittier, California, 90602-1005
- Recruiting
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610-3206
Site Contact, 610-374-8133, gemkeyresearch@emkeyarthritis.com
Gregory Emkey
Poland27 sites, 27 recruiting
- Recruiting
INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland
Bialystok, Podlaskie Voivodeship, 15-077
Site Contact, 48604442168, klimiuk_piotr@yahoo.com
Piotr Klimiuk
- Recruiting
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, 15-077
Site Contact, 518630640, izadomyslawska@o2.pl
Izabela Domyslawska
- Recruiting
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, Podlaskie Voivodeship, 15-351
Site Contact, 48660456566, osteo_medic_bial@op.pl
Artur Racewicz
- Recruiting
Bif-Med s.c. NZOZ
Bytom, Silesian Voivodeship, 41-902
Site Contact, (50) 827-0636, hannamastalerz@wp.pl
Hanna Mastalerz
- Recruiting
UNICA CR sp. z.o. o.
Dąbrówka, Warmian-Masurian Voivodeship, 62-069
Site Contact, elzbieta.gigiel@unica-cr.pl
Elżbieta Gigiel
- Recruiting
Ambulatorium Sp. z o.o.
Elblag, Warmian-Masurian Voivodeship, 82-300
Site Contact, +48602466155, bazela.ann@gmail.com
Anna Bazela-Ostromecka
- Recruiting
Centrum Medyczne Katowice - PRATIA
Katowice, Lower Silesian Voivodeship, 40-081
Site Contact, 48 604-215-132, tdziewit@pratia.pl
Tomasz Dziewit
- Recruiting
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
Site Contact, 48 501150912, alawloch@interia.pl
Alicja Wloch
- Recruiting
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727
Site Contact, 48 122954139, mariusz.korkosz@pratia.com
Mariusz Korkosz
- Recruiting
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501
Site Contact, 48 695195414, weronika.szpakiewicz@futuremeds.com
Weronika Kleczynska-Szpakiewicz
- Recruiting
Santa Familia PTG Lodz | Lodz, Poland
Lodz, 90-302
Site Contact, tomasz.budlewski@ptg-network.com
Tomasz Budlewski
- Recruiting
FutureMeds | Lodz Center - Lodz, Poland
Lodz, 91-363
Site Contact, 48 505634090, katarzyna.bartnicka@futuremeds.com
Katarzyna Bartnicka-Maslowska
- Recruiting
Twoja Przychodnia | Nowa Sol, Poland
Nowa Sól, 67-100
Site Contact, miakisz@twojaprzychodnia.com
Malgorzata Miakisz
- Recruiting
Etyka Osrodek Badan Klinicznych | Olsztyn, Poland
Olsztyn, Warmian-Masurian Voivodeship, 10-117
Site Contact, magdalenakrajewska@etykaosrodek.pl
Magdalena Krajewska-Wlodarczyk
- Recruiting
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, Opole Voivodeship, 45-819
Site Contact, 48 690 548 825, gjaworska@opolemed.com
Grazyna Jaworska-Gorna
- Recruiting
Pratia Poznań
Poznan, Greater Poland Voivodeship, 60-192
Site Contact, magdalena.szyszko@pratia.com
Magdalena Szyszko
- Recruiting
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
Poznan, Wielkopolska, 60-324
Site Contact, wytyk@twojaprzychodnia.com
Agata Wytyk-Nowak
- Recruiting
Reumedika | Poznan, Poland
Poznan, Wlkp, 60-446
Site Contact, 48618866866, wporawska@reumedika.pl
Wieslawa Porawska
- Recruiting
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland
Poznan, Woj. Wielkopolskie, 61-397
Site Contact, 48883341493, pawel.hrycaj@gmail.com
Pawel Hrycaj
- Recruiting
RCMed | Sochaczew, Poland
Sochaczew, Masovian Voivodeship, 96-500
Site Contact, 48 468 611 390, monika.wronisz@rcmed.com.pl
Monika Wronisz
- Recruiting
MICS Centrum Medyczne Torun
Torun, Silesian Voivodeship, 87-100
Site Contact, 48 606453300, s.jeka@wp.pl
Slawomir Jeka
- Recruiting
Rheuma Medicus | Warsaw, Poland
Warsaw, Masovian Voivodeship, 02-118
Site Contact, 48 501792039, rell-bakalarska@wp.pl
Rell-Bakalarska Maria
- Recruiting
MTZ Clinical Research Powered by PRATIA
Warsaw, Masovian Voivodeship, 02-172
Site Contact, 48 22 572 59 59, rupinski@mp.pl
Robert Rupinski
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic
Warsaw, Masovian Voivodeship, 02-637
Site Contact, cwbk.brygidakwiatkowska@spartanska.pl
Brygida Kwiatkowska
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665
Site Contact, 48602328612, januszjaworski@ymail.com
Jaworski Janusz
- Recruiting
ETG Warszawa Sp. z o.o.
Warsaw, Masovian Voivodeship, 02-677
Site Contact, 48 575 000 749, a.rowinskaosuch@etg-network.com
Anna Rowinska-Osuch
- Recruiting
FutureMeds Wroclaw
Wroclaw, 53-673
Site Contact, 48 609593045, ewa.krecipro-nizinska@futuremeds.com
Ewa Krecipro-Nizinska
Mexico10 sites, 9 recruiting
- Recruiting
Office of Cesar F. Pacheco-Tena, MD
Chihuahua City, 31000
Site Contact, 6144373003, dr.cesarpacheco@gmail.com
Cesar Pacheco-Tena
- Recruiting
Centro Integral en Reumatologia, S.A. de C.V.
Guadalajara, Jalisco, 44160
Site Contact, 52 (01) 1202-0959, hilario_avila@hotmail.com
Hilario Avila-Armengol
- Recruiting
Private Practice - Dr. Delfina Villanueva Quintero
Guadalajara, Jalisco, 44600
Site Contact, luviq_16@yahoo.com.mx
Delfina Villanueva Quintero
- Recruiting
Consultorio de Reumatologia
Gustavo Adolfo Madero, Mexico City, 07760
Site Contact, 525557524673, smcv_1972@hotmail.com
Sandra Miriam Carrillo Vazquez
- Recruiting
Kohler and Milstein Research Yucatan
Mérida, Yucatán, 97070
Site Contact, 52 (01) 99-9920-4004, jabrahamsimon@yahoo.com.mx
J. Abraham Simon
- Recruiting
Hospitales Star Medica
Mérida, Yucatán, 97133
Site Contact, 529992863586, fcoaz68@hotmail.com
Francisco Avila Zapata
- Recruiting
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
Mexicali, Estado de Baja California, 21200
Site Contact, 52 (01) 686-553-4121, fidenciocons@gmail.com
Francisco Fidencio Cons Molina
- Withdrawn
HMG Hospital Coyoacan
Mexico City, Mexico City, 06720
- Recruiting
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, Mexico City, 11850
Site Contact, 5526143031, fedraira@prodigy.net.mx
Fedra Irazoque-Palazuelos
- Recruiting
iBiomed Guadalajara
Zapopan, Guadalajara, 44160
Site Contact, 3323162040 101, adriana.sanchez@investigacionbiomedica.com.mx
Adriana Sanchez Ortiz
Bulgaria9 sites, 7 recruiting
- Recruiting
Medical Center Medconsult Pleven OOD
Pleven, 5800
Site Contact, 359897046117, ktsoneva_medconsult@abv.bg
Krasimira Tsoneva
- Recruiting
AES Partner Site -Plovdiv
Plovdiv, 4000
Site Contact, 00359 888196602, yakov.rheumatology@gmail.com
Ivan Yakov
- Recruiting
Medical Center Artmed OOD | Plovdiv, Bulgaria
Plovdiv, 4000
Site Contact, 0898 523 128, dr.mariela.geneva@gmail.com
Mariela Geneva-Popova
- Completed
Diagnostic- Consultative Center- 1- Ruse EOOD
Rousse, 7002
- Recruiting
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Sofia-Grad, 1463
Site Contact, 35929586364, proff_rashkov@yahoo.com
Rasho Rashkov
- Recruiting
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia
Sofia, Sofia-Grad, 1606
Site Contact, 359888985531, oparanov@abv.bg
Boycho Oparanov
- Recruiting
Centre of Rheumatology St. Irina
Sofia, Sofia-Grad, 1784
Site Contact, 359888813435, rodina_usd@abv.bg
Rodina Licheva
- Completed
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria
Stara Zagora, 6000
- Recruiting
Medical Center Zara-Med EOOD
Stara Zagora, 6000
Site Contact, 359882887889, hr_vassilev@abv.bg
Hristo Vasilev
Czechia9 sites, 8 recruiting
- Recruiting
Revmatologie s.r.o. | Brno, Czech Republic
Brno, Czech Rep, 63800
Site Contact, +420604919772, revmatologie.prochazkova@seznam.cz
Leona Prochazkova
- Active, not recruiting
L.K.N. Arthrocentrum, s.r.o. - Revmatologicka
Hlučín, Czech Rep, 92307
- Recruiting
CCR Ostrava
Ostrava, Moravian-Silesian Region, 702 00
Site Contact, sylva.brtnikova@ccrostrava.com
Sylva Brtnikova
- Recruiting
Pratia Pardubice a.s.
Pardubice, 53002
Site Contact, 00420606298371, maca.svobodova@post.cz
Marcela Svobodova
- Recruiting
Clintrial s.r.o. | Prague, Czech Republic
Prague, Czech Rep, 100 00
Site Contact, 420 222 510 607, v.gollerova@clintrial.cz
Vlasta Gollerova
- Recruiting
Praglandia | Prague, Czech Republic
Prague, Czech Rep, 150 00
Site Contact, a.voc@praglandia.cz
Andrea Vocilkova
- Recruiting
Revmatologicky ustav | Clinical Evaluation Department
Prague, Prague, 12800
Site Contact, zavada@revma.cz
Jakub Zavada
- Recruiting
MEDICAL Plus s.r.o.
Uherské Hradiště, Czech Rep, 68601
Site Contact, evadokoupil@gmail.com
Eva Dokoupilova
- Recruiting
Pv Medical Services
Zlín, NAP, 760 01
Site Contact, pv.medical@seznam.cz
Petr Vitek
Italy9 sites, 9 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Site Contact, 00390557946457, serena.guiducci@unifi.it
Serena Guiducci
- Recruiting
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Lombardy, 20122
Site Contact, 00390258296272, ennio.favalli@asst-pini-cto.it
Ennio Giulio Favalli
- Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy, 20132
Site Contact, 390226433828, dagna.lorenzo@unisr.it
Lorenzo Dagna
- Recruiting
Azienda Ospedale Università Padova
Padova, Veneto, 35128
Site Contact, 390498212199, roberta.ramonda@unipd.it
Roberta Ramonda
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Site Contact, 390502218290, marta.mosca@unipi.it
Marta Mosca
- Recruiting
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133
Site Contact, 00390694377533, maria.sole.chimenti@uniroma2.it
Maria Sole Chimenti
- Recruiting
Policlinico Agostino Gemelli, UOC Reumatology
Rome, Lazio, 168
Site Contact, 00390630157803, mariaantonietta.dagostino@policlinicogemelli.it
Maria Antonietta D'Agostino
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089
Site Contact, 390282246161, carlo.selmi@hunimed.eu
Carlo Francesco Selmi
- Recruiting
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, Ancona, 60126
Site Contact, 00390715964200, m.luchetti@staff.univpm.it
Michele Maria Luchetti Gentiloni
Germany8 sites, 8 recruiting
- Recruiting
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Site Contact, 495922745210, a.tsianakas@fk-bentheim.de
Athanasios Tsianakas
- Recruiting
Rheumzentrum Prof.Dr.med.Gunther Neeck
Bad Doberan, Mecklenburg-Vorpommern, 18209
Site Contact, 493820373190, gunther.neeck@biomedro.de
Gunther Neeck
- Recruiting
Rheumatologische Schwerpunktpraxis | Berlin, Germany
Berlin, 12161
Site Contact, 30-85-99-33-90, jan.brandt-juergens@charite.de
Jan Brandt-Jurgens
- Recruiting
Städtisches Klinikum Dresden
Dresden, 01067
Site Contact, leonore.unger@klinikum-dresden.de
Leonore Unger
- Recruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
Hamburg, 20095
Site Contact, 49(0)43-31-33-76-60, everding@hotmail.de
Andrea Everding
- Recruiting
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, 4103
Site Contact, matthias.pierer@medizin.uni-leipzig.de
Matthias Pierer
- Recruiting
Medicover MVZ München Ost
München, 81667
Site Contact, david.kofler@medicover.de
David Kofler
- Recruiting
Rheumazentrum Ratingen-Studienambulanz
Ratingen, North Rhine-Westphalia, 40878
Site Contact, 4921025533788, studien@rhzr.de
Siegfried Wassenberg
Hungary6 sites, 6 recruiting
- Recruiting
Qualiclinic | Budapest, Hungary
Budapest, 1036
Site Contact, 36309606109, i.szombati@qclinic.hu
Istvan Szombati
- Recruiting
Porcika Klinika
Hódmezővásárhely, Csongrad-Csanad, 6800
Site Contact, 36203265302, jimbies@gmail.hu
Eva Balazs
- Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrad-Csanad, 6720
Site Contact, 36204718443, balog.attila@med.u-szeged.hu
Attila Balog
- Recruiting
CMed Rehabilitacios es Diagnosztikai Kozpont
Székesfehérvár, Fejér, 8000
Site Contact, 36305335228, vargatundedr1@gmail.com
Tunde Varga
- Recruiting
Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center
Székesfehérvár, 8000
Site Contact, 36209223932, juditpulai@gmail.com
Judit Pulai
- Recruiting
Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary
Veszprém, 8200
Site Contact, 36 88325947, dr.dreschere@gmail.com
Edit Drescher
Israel6 sites, 6 recruiting
- Recruiting
Assuta Ashdod Medical Center
Ashdod, Southern District, 7747629
Site Contact, 972 (0) 3-9377710, yonataned@assuta.co.il
Yonatan Edel
- Recruiting
Barzilai Medical Center | Rheumatology Department
Ashkelon, 7830604
Site Contact, 972 0537088864, jenniferb@bmc.gov.il
Jennifer (Guttman) Ben Shimol
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
Site Contact, 972 (0) 3-978-80-04, Y_braun@rambam.health.gov.il
Yolanda Braun-Moscovici
- Recruiting
Galilee Medical Center | Rheumatology Unit
Nahariya, 2210001
Site Contact, 972 548354112, MohammadN@gmc.gov.il
Mohammad E. Naffaa
- Recruiting
The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases
Ramat Gan, 5265601
Site Contact, 97235304413, merav.lidar@sheba.health.gov.il
Merav Lidar
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Site Contact, 00972-3-6973668, orie@tlvmc.gov.il
Elkayam Ori
Portugal6 sites, 6 recruiting
- Recruiting
Hospital Garcia de Orta
Almada, 2805-267
Site Contact, +351 212724264, mjps1234@gmail.com
Maria Jose Parreira dos Santos
- Recruiting
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
Coimbra, Barcelona, 3004-561
Site Contact, mary.lucy.marques@gmail.com
Mary Lucy Marques
- Recruiting
Instituto Portugues de Reumatologia
Lisbon, 1050-034
Site Contact, lcunhamiranda@hotmail.com
Luis Miguel da Cunha Cristovao Botelho de Miranda
- Recruiting
Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department
Lisbon, 1649-035
Site Contact, +351210405814, elsasousa@medicina.ulisboa.pt
Elsa Vieira de Sousa
- Recruiting
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
Ponte de Lima, Barcelona, 4990-041
Site Contact, 919336738, jose.costa@ulsam.min-saude.pt
Jose Antonio Tavares Da Costa
- Recruiting
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
Vila Nova de Gaia, New Mexico, 4434-502
Site Contact, diogo.fonseca@ulsge.min-saude.pt
Diogo Fonseca
Spain6 sites, 5 recruiting
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
Site Contact, 951290200, afnebro@gmail.com
Antonio Fernandez-Nebro
- Completed
Hospital Universitario de Badajoz
Mérida, Badajoz, 06006
- Recruiting
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell, Barcelona, 08208
Site Contact, 34937231010 84082, moreno.parctauli@gmail.com
Mireia Moreno Martinez-Losa
- Recruiting
Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department
Santiago de Compostela, Galicia, 15706
Site Contact, (3498) 195-1036, antonio.jose.mera.varela@sergas.es
ANTONIO MERA-VARELA
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Site Contact, 34955008000, perez.venegas@gmail.com
Jose Perez Venegas
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Site Contact, +34961973787, delaeme84@gmail.com
Isabel de la Morena Barrio
Belgium5 sites, 5 recruiting
- Recruiting
Université Libre de Bruxelles
Anderlecht, Brussels Capital, 1070
Site Contact, 32 2 555 65 79, joelle.margaux@hubruxelles.be
Joelle Margaux
- Recruiting
St Pierre Brussels
Brussels, 1000
Site Contact, silvana.diromana@stpierre-bru.be
Silvana Di Romana
- Recruiting
ReumaClinic Genk
Genk, Limburg, 3600
Site Contact, 32 89 362977, johan@vanhoofjohan.be
Johan Vanhoof
- Recruiting
University Hospital Ghent
Ghent, Flanders, 9000
Site Contact, filip.vandenbosch@ugent.be
Filip Van Den Bosch
- Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000
Site Contact, 32 4 323 72 41, Clio.Ribbens@chuliege.be
Clio Ribbens
Chile5 sites, 5 recruiting
- Recruiting
El Centro de Estudios Reumatologicos (CER)
Providencia, Santiago Metropolitan, 7500000
Site Contact, dr.pedromiranda@gmail.com
Pedro Claudio Miranda Cabezas
- Recruiting
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881
Site Contact, 56229540251, ccruzf@gmail.com
Claudia Paz De La Cruz Fernandez
- Recruiting
Centro de Estudios Clinicos
Santiago, 8320000
Site Contact, ivangonzalez44@yahoo.com
Ivan Gonzalez
- Recruiting
CTR Estudios
Santiago, 8320000
Site Contact, luisa_donaire@yahoo.es
Luisa Andrea Donaire Romo
- Recruiting
Centro Internacional de Estudios Clínicos
Santiago, 8420383
Site Contact, fvalenzuela.cl@gmail.com
Fernando Valenzuela Ahumada
Croatia5 sites, 4 recruiting
- Recruiting
Clinical Hospital Centre Osijek
Osijek, 31000
Site Contact, 385989801142, jmilasahic@gmail.com
Jasminka Milas-Ahic
- Recruiting
Clinical Hospital Center Rijeka
Rijeka, 51000
Site Contact, 385 91 155 1015, srdan.novak@gmail.com
Srdan Novak
- Recruiting
University Hospital Centre Split
Split, 21000
Site Contact, +385 91 611 2270, mislavradic@gmail.com
Mislav Radic
- Completed
General Hospital Zadar
Zadar, 23000
- Recruiting
Medicinski Centar Kuna and Peric
Zagreb, City of Zagreb, 10000
Site Contact, +385 98 511 193, porin.peric@gmail.com
Porin Peric
Estonia5 sites, 5 recruiting
- Recruiting
Innomedica OU | Tallinn, Estonia
Tallinn, Harju, 10117
Sandra Meisalu, sandra.meisalu@innomedica.ee
Sandra Meisalu
- Recruiting
Center for Clinical and Basic Research
Tallinn, Harju, 10128
Site Contact, ivo.valter@nordestmedical.eu
Ivo Valter
- Recruiting
North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department
Tallinn, 13419
Site Contact, 372 617 1300, eve-kai.raussi@regionaalhaigla.ee
Eve-Kai Raussi
- Recruiting
Clinical Research Centre | Tartu, Estonia
Tartu, Tartu, 50106
Site Contact, airi.poder@std.ee
Airi Poder
- Recruiting
MediTrials OÜ
Tartu, 50708
Site Contact, raili.myller@meditrials.ee
Raili Mueller
New Zealand5 sites, 5 recruiting
- Recruiting
Aotearoa Clinical Trials
Auckland, North Island, 2025
Site Contact, 00 64 9 276 0000, mark.sapsford@middlemore.co.nz
Mark Sapsford
- Recruiting
North Shore Hospital
Auckland, North Island, 6022
Site Contact, 00 64 21 589 228, Sue.Austin@waitematadhb.govt.nz
Kristine Ng
- Recruiting
CGM Research Trust
Christchurch Central, Christchurch, 8013
Site Contact, 64 3 365 6777, nigel.gilchrist@cgm.org.nz
Nigel Gilchrist
- Recruiting
Waikato Hospital
Hamilton, Waikato Region, 8011
Site Contact, 00 64 7 839 8660, douglas.white@waikatodhb.health.nz
Douglas White
- Recruiting
Porter Rheumatology Ltd
Nelson, South Island, 7010
Site Contact, david.porter@uphs.upenn.edu
David Porter
South Korea5 sites, 5 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Site Contact, 82 2 3010 3271, cklee@amc.seoul.kr
Chang-Keun Lee
- Recruiting
SMG - SNU Boramae Medical Center
Seoul, 07061
Site Contact, 82 (0) 2-840-2114, kideb1@snu.ac.kr
Kichul Shin
- Recruiting
Kyung Hee University Hospital
Seoul, 2447
Site Contact, 82 0 2-1577-5800, jsunok-n@hanmail.net
Yeon-Ah Lee
- Recruiting
The Catholic University of Korea
Suwon, Gyeonggi-do, 16247
Site Contact, 821066000000, jwas@catholic.ac.kr
Yune-Jung Park
- Recruiting
Ajou University Hospital | Clinical Trial Center
Suwon, Gyeonggido, 16499
Site Contact, 82-31-219-5118, chsuh@ajou.ac.kr
Chang-Hee Suh
Taiwan5 sites, 5 recruiting
- Recruiting
Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department
New Taipei City, 220
Site Contact, 886 2 77282148, wucs.tw@gmail.com
Chien-Sheng Wu
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
Site Contact, 866 4-24739595, jccwei@gmail.com
James Cheng-Chung Wei
- Recruiting
National Cheng Kung University
Tainan, Tainan City, 701
Site Contact, 886 6-2353535, maggieweng69@gmail.com
Meng-Yu Weng
- Recruiting
Chi Mei Medical Center
Tainan, 710
Site Contact, 886 6-281-2811, hachen801039@yahoo.com.tw
Hung-An Chen
- Recruiting
National Taiwan University Hospital
Zhong Zheng Qu, Taipei City, 100
Site Contact, 886223123456, tftsai@ntuh.gov.tw
Tsen-Fang Tsai
Latvia2 sites, 2 recruiting
- Recruiting
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
Liepāja, 3401
Site Contact, 371 (0) 34-29509038, dskap@inbox.lv
Daina Saulite-Kandevica
- Recruiting
ORTO Clinic | Rheumatology Department
Riga, LV-1005
Site Contact, 371 67144013, annamihailova@inbox.lv
Anna Mihailova
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro Reumatologico de Caguas | Caguas, PR
Caguas, 00725
Site Contact, ajperez@crcsalud.com
Amarilis Perez De Jesus
- Recruiting
GCM Medical Group, PSC | San Juan, PR
San Juan, 00917
Site Contact, drakarinavila@gmail.com
Karina Vila-Rivera
About this study
Official title: 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Zasocitinib, Active Comparator, Placebo
- Keywords
- Drug Therapy, Latitude Research Program, Latitude PsA, Latitude PsA-3001
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZasocitinibDrug
Also called TAK- 279, NDI-034858
Zasocitinib over-encapsulated tablets.
Active ComparatorDrug
Active comparator capsule.
PlaceboDrug
Zasocitinib or active comparator matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Zasocitinib Dose A | Experimental | Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52. Receives: Drug: Zasocitinib |
| Zasocitinib Dose B | Experimental | Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52. Receives: Drug: Zasocitinib |
| Active Comparator Dose C | Active comparator | Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52. Receives: Drug: Active Comparator |
| Placebo + Zasoctinib | Experimental | 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. Receives: Drug: Zasocitinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: At Week 16
Secondary outcomes (31)
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI-75) Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: Baseline, at Week 16
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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, 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.
Measured: At Week 16
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: At Week 16
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: Baseline, 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 and B Compared to Placebo
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.
Measured: 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 and B Compared to Placebo
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.
Measured: Baseline, at Week 16
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: At Week 16
Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 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
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.
Measured: Baseline, at Week 4 and 8
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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, at Week 16
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
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
Measured: Baseline up to Week 16
Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo
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.
Measured: At Week 8
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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.
Measured: At Week 16
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start3 Mar 2025
- Primary completion18 May 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,088 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671483
- Sponsor's protocol ID
- TAK-279-PsA-3001
- Other IDs
- 2024-513111-27-00
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.