Continued daily zasocitinib treatment for adults with psoriatic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Jeffrey Loomer, MD Arizona Arthritis & Rheumatology Research
  Tucson, Arizona, United States Recruiting
• First OC Dermatology Research Inc.
  Fountain Valley, California, United States Recruiting
• Purushotham & Akther Kotha MD
  La Mesa, California, United States Recruiting
• Triwest Research Associates LLC
  La Mesa, California, United States Recruiting
• The Cohen Medical Centers
  Thousand Oaks, California, United States Recruiting
• Denver Arthritis Clinic - Lowry
  Denver, Colorado, United States Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.