Continued daily zasocitinib treatment for 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

This extension will try daily zasocitinib in adults with psoriatic arthritis who completed a year of earlier treatment to see how well it works and how safe it is over about two years.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1182 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Drugs / interventions: zasocitinib
• Locations: 1 site (Fountain Valley, California)
• Trial ID: NCT07286058 on ClinicalTrials.gov

What this trial studies

This long-term extension enrolls adults with psoriatic arthritis who completed the 52-week treatment period in specified parent Phase 3 studies. All participants will receive oral zasocitinib once daily at a protocol-defined lower or higher dose. Participants are followed for up to 104 weeks of treatment plus a 4-week safety follow-up, with regular visits for symptom assessments, lab tests, and monitoring of adverse events. The primary focus is on long-term safety, tolerability, and maintenance of clinical response.

Who should consider this trial

Good fit: Adults (≥18 years, ≥19 in South Korea) who completed the 52-week parent study period (TAK-279-PsA-3001 or TAK-279-PsA-3002) and whom the investigator deems likely to benefit from continued or newly started zasocitinib are eligible.

Not a fit: Patients who showed no improvement or worsened during the parent study or who met criteria for permanent discontinuation in the parent trials are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, continued zasocitinib could help maintain symptom control and offer a convenient long-term oral treatment option for adults with psoriatic arthritis.

How similar studies have performed: Other oral targeted kinase inhibitors for psoriatic arthritis have demonstrated clinical benefit, and this extension continues follow-up of participants from Phase 3 parent studies.

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).

Where this trial is running

Fountain Valley, California

• First OC Dermatology Research Inc. — Fountain Valley, California, United States (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Psoriatic Arthritis; Drug Therapy; Latitude PsA; Latitude PsA-3003