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Taking people in ItalyPhase 3

Long-term study of zasocitinib for joint and skin psoriatic arthritis

Checks long-term safety of zasocitinib in adults with active psoriatic arthritis.

Key facts

Who runs it
Takeda
Where
Ancona, Florence, Milan, Padova, Pisa, Rome, and Rozzano, ItalySee the 9 sitesAlso in 23 other countries, 173 sites
Registry title
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Status
Recruiting
Phase
Phase 3
People taking part
1,182 people, planned
Started
11 Mar 2026
Expected to end
18 Dec 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Zasocitinib
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with psoriatic arthritis who finished the 52-week treatment period in one of two earlier zasocitinib studies. All take zasocitinib once a day.

Age
18 years or older (19 years or older in South Korea).
Sex
All sexes can join.
Disease stage
Psoriatic arthritis, in people whose doctor thinks they can benefit from zasocitinib.
Earlier treatment
Must have completed the 52-week treatment period in study TAK-279-PsA-3001 or TAK-279-PsA-3002, without having to stop the treatment permanently.

Main reasons for not taking part

  • The doctor thinks the person did not benefit from the treatment in the earlier study.
  • Met the criteria for permanent stop of treatment in the earlier study.
  • Developed another disease that could confuse the results, such as rheumatoid arthritis, lupus, gout or fibromyalgia.
  • Developed a skin condition that could interfere with the study assessments.

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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
  • 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
  • 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

Who cannot take part

  • 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)
  • 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
  • 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
  • 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)

Where in Italy

Also in 23 other countries, 173 sites

  • Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
  • Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
  • Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Azienda Ospedaliera di PadovaPadova, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people

About the trial

What the trial wants to find out

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.

Read full original descriptionShow less

The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.

Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).

Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

The 2 groups in the trial

  • Zasocitinib Dose A or Dose BTreatment being tested

    Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.

    Treatment: Zasocitinib

  • Re-randomized Participants - Zasocitinib Dose A or Dose BTreatment being tested

    Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.

    Treatment: Zasocitinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Long-term study of zasocitinib for joint and skin psoriatic arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026