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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06671496

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Zasocitinib in Adults With Active Psoriatic Arthritis With or Without Prior Biologic Treatment

Led by Takeda · Updated on 2026-04-06

600

Participants Needed

122

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Psoriatic arthritis PsA is a chronic inflammatory disease affecting the joints and skin in people with psoriasis. Researchers are evaluating how well the drug zasocitinib TAK-279 works in adults with active PsA, considering their prior experiences with specific treatments. This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study sponsored by Takeda, focusing on participants with or without previous biologic medicine use. Participants will be assigned to one of three groups one receiving zasocitinib Dose A, another receiving Dose B, both taken orally once daily for up to 52 weeks, and a third group receiving placebo orally once daily for 16 weeks followed by zasocitinib Dose A or Dose B from weeks 16 to 52. The study lasts up to 60 weeks, including the treatment period and follow-up. During the study, participants will undergo assessments to measure improvement in PsA symptoms, including joint tenderness and swelling, skin lesion severity, physical function, fatigue, and overall disease impact using recognized scales such as the American College of Rheumatology ACR responses and Psoriasis Area and Severity Index PASI. Safety and efficacy will be monitored throughout the 52-week treatment and at regular intervals.

CONDITIONS

Brief Title

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older at the time of consent.
  • Diagnosis of psoriatic arthritis.
  • Signs and symptoms of psoriatic arthritis for at least 3 months before screening.
  • Meet the Classification Criteria for Psoriatic Arthritis (CASPAR).
  • Active arthritis with at least 3 tender joints and 3 swollen joints at screening and baseline.
  • At least one active plaque psoriasis lesion 2 cm or larger, or characteristic nail psoriasis changes.
  • History of inadequate response to at least one of the following: NSAIDs (not applicable in EU/EEA), conventional synthetic DMARDs, or up to two biologic DMARDs.
Not Eligible

You will not qualify if you...

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

Research Team

T

Takeda Contact

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