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Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full 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).

About the study

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

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.

What is being tested

Sponsor: Takeda · Participants: 1,182 · Started: Mar 11, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07286058

Locations in the U.S.

ArizonaJeffrey Loomer, MD Arizona Arthritis & Rheumatology Research, Tucson
CaliforniaFirst OC Dermatology Research Inc., Fountain Valley
Purushotham & Akther Kotha MD, La Mesa
Triwest Research Associates LLC, La Mesa
The Cohen Medical Centers, Thousand Oaks
ColoradoDenver Arthritis Clinic - Lowry, Denver
FloridaDirect Helpers Research Center, Hialeah
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research, Hialeah
IRIS Research and Development, Plantation
MarylandKlein and Associates, M.D., P.A., Hagerstown
OhioParamount Medical Research & Consulting, LLC, Middleburg Heights
TennesseeWest Tennessee Research Institute, Jackson
TexasAccurate Clinical Research, Baytown
Novel Research LLC, Bellaire
Northwest Houston Arthritis Center, Houston
Novel Research | Abigail Neiman - Houston, TX, Houston
West Texas Clinical Research, Lubbock
Southwest Rheumatology Research, LLC, Mesquite
Advanced Rheumatology of Houston, The Woodlands

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.