NCT07286058 Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
| NCT ID | NCT07286058 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Takeda |
| Condition | Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,182 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2029-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,182 participants in total. It began in 2026-03-11 with a primary completion date of 2029-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age. 2. 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. 3. 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. Exclusion Criteria: 1. 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. 2. 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). 3. 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. 4. 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 & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT07286058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07286058 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,182 participants.
Is NCT07286058 currently recruiting?
Yes, NCT07286058 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT07286058 trial being conducted?
This trial is being conducted at Fountain Valley, United States, Thousand Oaks, United States, Denver, United States, Hialeah, United States and 11 additional locations.
Who is sponsoring the NCT07286058 clinical trial?
NCT07286058 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 1,182 participants.