Psoriatic ArthritisPhase 3NCT07286058
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
A Phase 3 study testing Zasocitinib in people with Psoriatic Arthritis, run by Takeda at 78 sites in 16 countries.
Trial summary
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,182 participants
- Where
- 78 sitesin 16 countries
- Study dates
- 11 Mar 2026to 18 Dec 2029
- 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
- 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.
- The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.
- The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.
Who cannot join
- Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study.
- Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002).
- The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
- The participant has developed evidence of 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
78 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
78 sites in 16 countries
United States19 sites, 19 recruiting
- Recruiting
Accurate Clinical Research
Baytown, Texas, 77521
Site Contact, 832-705-7839, snajammd@accurateclinicalresearch.com
Sabeen Najam
- Recruiting
Novel Research LLC
Bellaire, Texas, 77401
Site Contact, 832-400-2262, wajeeha@novelresearch.net
Wajeeha Yousaf
- Recruiting
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230
Site Contact, rantolini@dacdenver.com
Christopher Antolini
- Recruiting
First OC Dermatology Research Inc.
Fountain Valley, California, 92708
Site Contact, 714-531-2966, vivian.laquer@firstocdermresearch.com
Vivian Laquer
- Recruiting
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, 21740-6138
Site Contact, 301-791-6680, ookoye@rheumdocs.com
Okechukwu Okoye
- Recruiting
Direct Helpers Research Center
Hialeah, Florida, 33012
Site Contact, 305-828-3555, don@dhrtrials.com
Frank Don
- Recruiting
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, 33016
Site Contact, csesin1979@aol.com
Carlos Sesin
- Recruiting
Novel Research | Abigail Neiman - Houston, TX
Houston, Texas, 77024
Site Contact, neiman@novelresearch.net
Abigail Neiman
- Recruiting
Northwest Houston Arthritis Center
Houston, Texas, 77090
Site Contact, 832-834-5627, adnan@novelresearch.net
Adnan Peer
- 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, 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
West Texas Clinical Research
Lubbock, Texas, 79424
Site Contact, 806-993-1040, jitendra.vasandani@yahoo.com
Jitendra Vasandani
- Recruiting
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150
Site Contact, 972-288-2600, asinghal@swrr.net
Atul Singhal
- Recruiting
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Site Contact, 440-826-0742, idiabmd@gmail.com
Isam Diab
- Recruiting
IRIS Research and Development
Plantation, Florida, 33324
Site Contact, 954-476-2338, drvalenzuela@irisrheumatology.com
Guillermo Valenzuela
- Recruiting
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382united
Site Contact, 281-766-7886, tbrionez@gmail.com
Tamar Brionez
- Recruiting
The Cohen Medical Centers
Thousand Oaks, California, 91360-3967
Site Contact, 805-904-0982, drcohen@wmresearch.com
Shariar Cohen-Gadol
- Recruiting
Jeffrey Loomer, MD Arizona Arthritis & Rheumatology Research
Tucson, Arizona, 85748
Site Contact, 85748, loomer.research@azarthritis.com
Jeffrey Loomer
Poland17 sites, 17 recruiting
- Recruiting
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, 15-077
Site Contact, 48604442168, klimiuk_piotr@yahoo.com
Piotr Klimiuk
- Recruiting
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, 15-351
Site Contact, 48 (0) 85-7465544, artur.racewicz@gmail.com
Artur Racewicz
- Recruiting
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15707
Site Contact, 518630640, izadomyslawska@o2.pl
Izabela Domyslawska
- Recruiting
NZOZ BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafal Roykiewicz
Bytom, 41-902
Site Contact, (50) 827-0636, hannamastalerz@wp.pl
Hanna Mastalerz
- Recruiting
Pratia MCM Krakow
Krakow, 30-727
Site Contact, 48 122954139, mariusz.korkosz@pratia.com
Mariusz Korkosz
- Recruiting
Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, 67-100
Site Contact, 48 693 652 007, miakisz@twojaprzychodnia.com
Malgorzata Miakisz
- Recruiting
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45-819
Site Contact, 48 690 548 825, gjaworska@opolemed.com
Grazyna Jaworska-Gorna
- Recruiting
Pratia Poznań
Poznan, 60-192
Site Contact, 48506969916, magdalena.szyszko@pratia.com
Magdalena Szyszko
- Recruiting
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
Poznan, 60-324
Site Contact, 48 724 444 299, wytyk@twojaprzychodnia.com
Agata Wytyk-Nowak
- Recruiting
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
Poznan, 61-397
Site Contact, 48883341493, pawel.hrycaj@gmail.com
Pawel Hrycaj
- Recruiting
RCMed Oddzial Sochaczew
Sochaczew, 96-500
Site Contact, 48 468 611 390, monika.wronisz@rcmed.com.pl
Monika Wronisz
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
Site Contact, 48 606453300, s.jeka@wp.pl
Slawomir Jeka
- Recruiting
Rheuma Medicus Sp. z o.o.
Warsaw, 02-118
Site Contact, 48 501792039, rell-bakalarska@wp.pl
Maria Rell-Bakalarska
- Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, 02-172
Site Contact, 48 604 610 977, rupinski@mp.pl
Robert Rupinski
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, 02-665
Site Contact, 48602328612, januszjaworski@ymail.com
Janusz Jaworski
- Recruiting
ETG Warszawa Sp. z o.o.
Warsaw, 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
China12 sites, 12 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou Shi, Inner Mongolia, 014010
Site Contact, 18686198868, wyf18686198868@163.com
Yong-fu Wang
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Site Contact, 13501170870, bysyfsmyk@163.com
Rong Mu
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Site Contact, 13501069845, xiaofeng.zeng@cstar.org.cn
Xiaofeng Zeng
- Recruiting
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, Anhui, 233004
Site Contact, 15255227208, uglboy2002@126.com
Changhao Xie
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Site Contact, 13386277602, yi2006liu@163.com
Yi Liu
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, 610072
Site Contact, 18981838279, sujiangxy@126.com
Jiang Su
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Site Contact, 13503080061, 13503080061@126.com
Xiaoyan Cai
- Recruiting
Linyi People's Hospital
Linyi Shi, Shandong, 276000
Site Contact, 18305399766, lizunzhong0431@sina.com
Zunzhong Li
- Recruiting
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Site Contact, 13879936380, hjk0799@126.com
Jiankang Hu
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Site Contact, 86 13834676095, fuzili72@163.com
Zili Fu
- Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, 430022chin
Site Contact, 13995671635, Liqiubai_hust@hust.edu.cn
Qiubai Li
- Recruiting
Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Site Contact, 13007452129, 2990833152@qq.com
Jing-yang Li
Japan9 sites, 9 recruiting
- Recruiting
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
Site Contact, +81 3-3541-5151, satoshi.kawaai@gmail.com
Satoshi Kawaai
- Recruiting
Fukuoka University Hospital
Fukuoka, Hukuoka, 814-0180
Site Contact, 81928011011, simafuku.chiken@gmail.com
Shinichi Imafuku
- Recruiting
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902
Site Contact, 81 3-3411-0111, katsuyas.ntmc@gmail.com
Katsuya Suzuki
- Recruiting
Kojunkai Social Medical Corporation Daido Clinic
Minami-ku, Nagoya-shi, Aichi-ken, 457-8511
Site Contact, 81(0)52-611-6265, yoichirora1204@gmail.com
Yoichiro Haji
- Recruiting
Kyorin University Hospital
Mitaka-shi, Tokyo-To, 181-8611
Site Contact, +81 422-47-5511, kishimotomi@gmail.com
Mitsumasa Kishimoto
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Site Contact, 81528515511, amorita@med.nagoya-cu.ac.jp
Akimichi Morita
- Recruiting
Nippon Life Hospital
Osaka, Osaka, 550-0006
Site Contact, 81(0)6-644-33-446, shige.t1970@gmail.com
Shigeyoshi Tsuji
- Recruiting
Sasebo Chuo Hospital
Sasebo-shi, Nagasaki, 857-1195
Site Contact, 81 (0) 956-33-7151, cr-yu.ueki@hakujyujikai.or.jp
Yukitaka Ueki
- Recruiting
Mie University Hospital
Tsu, Mie, Mie-ken, 514-8507
Site Contact, 81 (0) 59-231-5025, yamake@clin.medic.mie-u.ac.jp
Keiichi Yamanaka
Czechia5 sites, 5 recruiting
- Recruiting
CCR Ostrava s.r.o.
Ostrava, 702 00
Site Contact, sylva.brtnikova@ccrostrava.com
Sylva Brtnikova
- Recruiting
Pratia Czech s.r.o.
Pardubice, 53002
Site Contact, 00420606298371, maca.svobodova@post.cz
Marcela Svobodova
- Recruiting
Praglandia
Prague, 150 00
Site Contact, a.voc@praglandia.cz
Andrea Vocilkova
- Recruiting
MEDICAL Plus s.r.o.
Uherské Hradiště, 68601
Site Contact, evadokoupil@gmail.com
Eva Dokoupilova
- Recruiting
Pv Medical Services
Zlín, 760 01
Site Contact, pv.medical@seznam.cz
Petr Vitek
Estonia4 sites, 4 recruiting
- Recruiting
Innomedica OU
Tallinn, 10117
Site Contact, sandra.meisalu@innomedica.ee
Sandra Meisalu
- Recruiting
North Estonia Medical Centre Foundation
Tallinn, 13419
Site Contact, +372 56 647 522, eve-kai.raussi@regionaalhaigla.ee
Eve-Kai Raussi
- Recruiting
Clinical Research Centre Ltd
Tartu, 50106Estoni
Site Contact, 3725058949, airi.poder@std.ee
Airi Poder
- Recruiting
MediTrials OÜ
Tartu, 50708
Site Contact, raili.myller@meditrials.ee
Raili Mueller
New Zealand2 sites, 2 recruiting
- Recruiting
CGM Research Trust
Christchurch Central, 8013
Site Contact, 64 3 365 6777, nigel.gilchrist@cgm.org.nz
Nigel Gilchrist
- Recruiting
Porter Rheumatology Ltd
Nelson, 7010
Site Contact, 006435483455, david@rheum.co.nz
David Porter
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro Reumatologico de Caguas
Caguas, 00725
Site Contact, 787-414-8465, ajperez@crcsalud.com
Amarilis Perez De Jesus
- Recruiting
GCM Medical Group, PSC
San Juan, 00917
Site Contact, drakarinavila@gmail.com
Karina Vila-Rivera
Australia1 site, 1 recruiting
- Recruiting
R.K. Will Pty Ltd
Victoria Park, Western Australia, 6100
Site Contact, 61894721904, robw@bdaus.com.au
Robert Will
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Center Rijeka - PPDS
Rijeka, 51000
Site Contact, 385 91 155 1015, srdan.novak@gmail.com
Srdan Novak
Germany1 site, 1 recruiting
- Recruiting
Hamburger Rheuma Forschungszentrum (HRF II) II
Hamburg, 20095
Site Contact, 49(0)43-31-33-76-60, everding@hotmail.de
Andrea Everding
Hungary1 site, 1 recruiting
- Recruiting
Vital Medical Center
Veszprém, 8200
Site Contact, 36 88325947, dr.dreschere@gmail.com
Edit Drescher
Israel1 site, 1 recruiting
- Recruiting
Galilee Medical Center
Nahariya, 2210001
Site Contact, 972 548354112, MohammadN@gmc.gov.il
Mohammad E. Naffaa
Latvia1 site, 1 recruiting
- Recruiting
Orto klīnika
Riga, LV-1005
Site Contact, 371 67144013, annamihailova@inbox.lv
Anna Mihailova
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Site Contact, 34690695711, ricardo.blanco@scsalud.es
Ricardo Blanco Alonso
Taiwan1 site, 1 recruiting
- Recruiting
Clinical Trial Center of Chung Shan Medical University Hospital
Taichung, 408413
Site Contact, 866 4-24739595, jccwei@gmail.com
James Cheng-Chung Wei
About this study
Official title: A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.
The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.
Read more
Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).
Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.
- Conditions
- Psoriatic Arthritis
- Being tested
- Zasocitinib
- Keywords
- Drug Therapy, Latitude PsA, Latitude PsA-3003
- 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 oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Zasocitinib Dose A or Dose B | Experimental | Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104. Receives: Drug: Zasocitinib |
| Re-randomized Participants - Zasocitinib Dose A or Dose B | Experimental | Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 [NCT06671483]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104. Receives: Drug: Zasocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
Measured: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Adverse Events of Special Interest (AESI)
An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Measured: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Vital Sign Values
Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
Measured: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.
Measured: From start of study drug administration up to follow-up (up to Week 108)
Secondary outcomes (5)
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104
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 percentage (%) 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 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).
Measured: At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104
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.
Measured: At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104
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.
Measured: At Weeks 24, 48, and 104
Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104
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 (PsO) <=3%, PtGA of PsA Pain score <=15, PtGA of PsA score <=20, HAQ-DI <=0.5, and Leeds Enthesitis Index (LEI) <=1.
Measured: At Weeks 24, 48, and 104
Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104
A PASI-75 response is defined as >=75% improvement in the PASI score from baseline. It is a ClinRO used to measure PsO severity, combining the percentage of surface area of skin affected 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 a complete lack of cutaneous involvement and 4 indicating the severest possible involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease.
Measured: At Weeks 24, 48, and 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start11 Mar 2026
- Primary completion18 Dec 2029 (estimated)
- Study completion18 Dec 2029 (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
- 1,182 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
- NCT07286058
- Sponsor's protocol ID
- TAK-279-PsA-3003
- Other IDs
- 2025-522586-30-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2025
- Last updated
- 9 Sep 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.