A Phase 3 interventional study of Zasocitinib in Psoriatic Arthritis, sponsored by Takeda. Recruiting at 78 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Takeda · Phase 3, Interventional, and Treatment
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.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 1,182 is above the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Zasocitinib
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.
Drug: Zasocitinib
Zasocitinib oral tablets.
Also known as: TAK- 279, NDI-034858
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From start of study drug administration up to follow-up (up to Week 108)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Weeks 24, 48, and 104
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · vivli.org
Started Mar 2026 (actual). Primary completion is estimated for Dec 2029, 45 months after the start.
Of 68 industry-sponsored phase 3 interventional studies under Arthritis, Psoriatic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's planned 45 months is above that.
Counting every sponsor, half of 74 studies reached it within 28 months; a quarter within 19 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Zasocitinib