Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
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
3 other identifiers
interventional
1,182
15 countries
77
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedStudy Start
First participant enrolled
March 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 18, 2029
September 9, 2026
September 1, 2026
3.8 years
December 11, 2025
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
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
At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104
At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104
At Weeks 24, 48, and 104
Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104
At Weeks 24, 48, and 104
Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104
At Weeks 24, 48, and 104
Study Arms (2)
Zasocitinib Dose A or Dose B
EXPERIMENTALParticipants 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.
Re-randomized Participants - Zasocitinib Dose A or Dose B
EXPERIMENTALParticipants 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.
Interventions
Zasocitinib oral tablets.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (78)
Jeffrey Loomer, MD Arizona Arthritis & Rheumatology Research
Tucson, Arizona, 85748, United States
First OC Dermatology Research Inc.
Fountain Valley, California, 92708, United States
Purushotham & Akther Kotha MD
La Mesa, California, 91942, United States
Triwest Research Associates LLC
La Mesa, California, 91942, United States
The Cohen Medical Centers
Thousand Oaks, California, 91360-3967, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, 33016, United States
IRIS Research and Development
Plantation, Florida, 33324, United States
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, 21740-6138, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Accurate Clinical Research
Baytown, Texas, 77521, United States
Novel Research LLC
Bellaire, Texas, 77401, United States
Novel Research | Abigail Neiman - Houston, TX
Houston, Texas, 77024, United States
Northwest Houston Arthritis Center
Houston, Texas, 77090, United States
West Texas Clinical Research
Lubbock, Texas, 79424, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382united, United States
R.K. Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, Anhui, 233004, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, 430022chin, China
Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
The First Affiliated Hospital of Baotou Medical College
Baotou Shi, Inner Mongolia, 014010, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Linyi People's Hospital
Linyi Shi, Shandong, 276000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, 610072, China
Clinical Hospital Center Rijeka - PPDS
Rijeka, 51000, Croatia
CCR Ostrava s.r.o.
Ostrava, 702 00, Czechia
Pratia Czech s.r.o.
Pardubice, 53002, Czechia
Praglandia
Prague, 150 00, Czechia
MEDICAL Plus s.r.o.
Uherské Hradiště, 68601, Czechia
Pv Medical Services
Zlín, 760 01, Czechia
Innomedica OU
Tallinn, 10117, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Clinical Research Centre Ltd
Tartu, 50106Estoni, Estonia
MediTrials OÜ
Tartu, 50708, Estonia
Hamburger Rheuma Forschungszentrum (HRF II) II
Hamburg, 20095, Germany
Vital Medical Center
Veszprém, 8200, Hungary
Galilee Medical Center
Nahariya, 2210001, Israel
Kojunkai Social Medical Corporation Daido Clinic
Minami-ku, Nagoya-shi, Aichi-ken, 457-8511, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Fukuoka University Hospital
Fukuoka, Hukuoka, 814-0180, Japan
Mie University Hospital
Tsu, Mie, Mie-ken, 514-8507, Japan
Sasebo Chuo Hospital
Sasebo-shi, Nagasaki, 857-1195, Japan
Nippon Life Hospital
Osaka, Osaka, 550-0006, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo-To, 181-8611, Japan
Orto klīnika
Riga, LV-1005, Latvia
CGM Research Trust
Christchurch Central, 8013, New Zealand
Porter Rheumatology Ltd
Nelson, 7010, New Zealand
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, 15-077, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, 15-351, Poland
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15707, Poland
NZOZ BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafal Roykiewicz
Bytom, 41-902, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, 67-100, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45-819, Poland
Pratia Poznań
Poznan, 60-192, Poland
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
Poznan, 60-324, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
RCMed Oddzial Sochaczew
Sochaczew, 96-500, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Rheuma Medicus Sp. z o.o.
Warsaw, 02-118, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, 02-172, Poland
Centrum Medyczne Reuma Park
Warsaw, 02-665, Poland
ETG Warszawa Sp. z o.o.
Warsaw, 02-677, Poland
FutureMeds Wroclaw
Wroclaw, 53-673, Poland
Centro Reumatologico de Caguas
Caguas, 00725, Puerto Rico
GCM Medical Group, PSC
San Juan, 00917, Puerto Rico
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Clinical Trial Center of Chung Shan Medical University Hospital
Taichung, 408413, Taiwan
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 16, 2025
Study Start
March 11, 2026
Primary Completion (Estimated)
December 18, 2029
Study Completion (Estimated)
December 18, 2029
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.