Zasocitinib Phase 3 Long-Term Extension

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

The Purpose of the Study

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this continuation (long-term extension) study is to check how safe the investigational drug zasocitinib is, how well it is tolerated, and how well it works in adults with PsA over a longer period of time.

What is Zasocitinib (TAK-279)?

Zasocitinib is an investigational, once-daily oral medication. It is an allosteric, highly selective, and potent tyrosine kinase 2 (TYK2) inhibitor. It works by targeting specific signaling pathways (such as interleukin-23 and interleukin-12) that are central to the inflammation seen in psoriatic arthritis, while minimizing the inhibition of other Janus kinase (JAK) enzymes to potentially reduce side effects.

Who Can Participate?

You may be eligible to participate if you:

  • Are an adult with active Psoriatic Arthritis.
  • Are either biologic DMARD-naïve or biologic DMARD-experienced, including those who have had an inadequate response to biologic DMARDs.
  • Have already successfully completed the 1-year (52-week) treatment period in one of the parent Phase 3 studies, such as TAK-279-PsA-3001 or TAK-279-PsA-3002.

What to Expect During the Trial

  • Study Design: This is a long-term extension (LTE) study, meaning there are no placebos used in this phase. All participants will receive the active study drug.
  • Dosing: Participants will take zasocitinib (at either a lower or higher dose) orally, once a day.
  • Monitoring: The treatment period will last for up to 104 weeks (approximately 2 years) to evaluate long-term safety and effectiveness. This is followed by a 4-week follow-up period to monitor health, making total participation approximately 108 weeks.

Why Participate?

By participating in this Phase 3 trial, you will help researchers evaluate the long-term safety and continued benefit of this treatment for chronic psoriatic arthritis. Because Phase 3 is the final step before potential FDA approval, your participation contributes directly to the development of a novel, once-daily oral therapy option for patients who may need alternatives to traditional biologic injections.