What is zasocitinib studying for psoriatic arthritis?

Zasocitinib is being studied to see how well it works in adults with active psoriatic arthritis who have not used biologic treatments before. The study aims to evaluate its effects on joint and skin symptoms. Takeda is leading this research to better understand treatment options for psoriatic arthritis.

Who may be eligible for this psoriatic arthritis clinical trial?

Adults aged 18 years or older with a diagnosis of psoriatic arthritis who have active joint symptoms and certain skin or nail signs may be eligible. Participants should have had symptoms for at least 3 months and meet specific disease criteria. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this psoriatic arthritis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses like travel may not be covered and can vary. Participants should consider these factors when deciding to join the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06671483

A Phase 3 Study Evaluating the Efficacy and Safety of Zasocitinib in Adults With Active Psoriatic Arthritis Who Have Not Taken Biologic Disease-Modifying Antirheumatic Drugs

Led by Takeda · Updated on 2026-06-02

1088

Participants Needed

189

Research Sites

36 weeks

Total Duration

AI-Summary

What this Trial Is About

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting the joints and skin in people with psoriasis. This study aims to understand how well the drug zasocitinib TAK-279 works in adults with active PsA who have never been treated with biologic disease-modifying antirheumatic drugs. Participants will be involved in this Phase 3 trial to evaluate the drugs effects and safety. Participants will be randomly assigned to one of several groups receiving different treatments. Some will take zasocitinib Dose A or Dose B tablets once daily for up to 52 weeks. Others will receive an active comparator capsule twice daily for up to 52 weeks. A placebo group will take placebo once daily for 16 weeks, then switch to zasocitinib Dose A or B from Week 16 to Week 52. This design allows comparison between the new drug, an active treatment, and placebo. During the study, participants will have regular visits and assessments to monitor their joint and skin symptoms. Researchers will measure responses using criteria like the American College of Rheumatology 20 ACR20 response at Week 16, among other disease activity and quality of life assessments. The study duration for each participant can last up to 60 weeks, including treatment and follow-up to evaluate the drugs impact and safety.

CONDITIONS

Brief Title

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be aged 18 years or older (19 years or older in South Korea) at the time of informed consent.
Have a diagnosis of psoriatic arthritis.
Have had signs and symptoms of psoriatic arthritis for at least 3 months before screening.
Meet the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
Have active arthritis with at least 3 tender joints and 3 swollen joints at screening and baseline.
Have at least one active plaque psoriasis lesion 2 cm or larger, or characteristic nail psoriasis changes.
Have had inadequate response to a nonsteroidal anti-inflammatory drug or a conventional synthetic disease-modifying antirheumatic drug for psoriatic arthritis.

You will not qualify if you...

Have other diseases that could affect the evaluation of zasocitinib, such as rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
Have a comorbid skin condition that may interfere with study assessments, such as non-plaque psoriasis types including erythrodermic, pustular, predominately guttate, inverse, or drug-induced psoriasis.

Research Team

Takeda Contact

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